Item 2. Management’s Discussion and Analysis
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with the financial
statements and the related notes included under Part I, Item 1 of this Quarterly Report on Form 10-Q (this “Quarterly Report”)
as well as the Company’s audited financial statements and notes thereto included in its Annual Report on Form 10-K for the year
ended December 31, 2023 that was filed with the SEC on April 16, 2024. Certain information contained in the discussion and analysis set
forth below includes forward-looking statements that involve risks and uncertainties. The following
discussion contains forward-looking statements based upon current expectations that involve risks, uncertainties and assumptions. Our
actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including
those set forth under the section titled “Risk Factors” or in other parts of this Quarterly Report . Our historical
results are not necessarily indicative of the results that may be expected for any period in the future. Conduit Pharmaceuticals Limited
entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Murphy Canyon Acquisition Corp. (“MURF”)
on November 8, 2022. The transaction contemplated by the terms of the Merger Agreement was completed on September 22, 2023, in conjunction
with which MURF changed its name to Conduit Pharmaceuticals Inc. (hereafter referred to, collectively with is subsidiaries as “Conduit”,
the “Company”, “we”, “us” or “our”, unless the context otherwise requires). All dollar
amounts are expressed in thousands of United States dollars (“$”), unless otherwise indicated.
Overview
Conduit
has developed a unique business model that allows it to act as a “conduit” to bring clinical assets from pharmaceutical companies
and develop new treatments for patients. Our novel approach addresses unmet medical need and lengthens the intellectual property for
our existing assets through cutting-edge solid-form technology and then commercialize these products with life science companies.
We
are led by highly experienced pharma executives, Dr. Freda Lewis-Hall, former Chief Medical Officer of Pfizer Inc., the Chair of our
Board of Directors, and Dr. David Tapolczay, former Chief Executive Officer of the United Kingdom-based medical research charity LifeArc,
our Chief Executive Officer.
While
simultaneously leveraging the capabilities of our Cambridge laboratory facility and highly experienced team of solid-form experts to
extend or develop proprietary solid-form intellectual property for our existing and future clinical assets. Our own intellectual property
portfolio comprises a 20-year patent pending solid-form compound, the AZD1656 Cocrystal (a HK-4 Glucokinase Activator), targeting a wide
range of autoimmune diseases. Our pipeline research includes a number of compounds that serve as promising alternatives to existing clinical
assets currently marketed and sold by large pharmaceutical companies, which we have identified as having an opportunity to develop further
intellectual property positions through solid-form technology.
In
connection with the funding and development of clinical assets, we evaluate and select the specific molecules to be developed and collaborate
with external CROs and KOLs to run clinical trials that are managed, funded, and overseen by us. We intend to leverage our comprehensive
clinical and scientific expertise in order to facilitate development of clinical assets through Phase II trials in an efficient manner
by using CROs and third-party service providers. We will also collaborate closely with disease specific KOLs to collectively assess and
determine the most appropriate indications for all our current and forthcoming assets.
We
believe that successful Phase II trials of the clinical assets in our pipeline will increase the value of our assets. There is no assurance
that any clinical trials on the assets owned or licensed by us will be successful, however, following a successful Phase II clinical
trial, we would look to licensing opportunities with large biotech or pharmaceutical companies, typically for up-front milestone payments
and royalty income streams for the life of the asset patent. We anticipate using any future royalty income stream to develop our asset
portfolio in combination with other potential sources of financing, including debt or equity financing.
Outside
of our proprietary owned patented clinical assets, we have an exclusive relationship and partnership with St George Street, a biomedical
charity based in the United Kingdom. We have the option to fund 100% of the development of clinical assets that were initially licensed
to St George Street by AstraZeneca. There may be additional opportunities for us to partner with St George Street to fund the
development of additional clinical assets in the future, licensed from Astra Zeneca.
26
AstraZeneca
has conducted initial pre-clinical and, in some instances, clinical trials on these assets, but has decided to license them for further
development.
In
addition to our patent pending solid-form compound targeting a wide range of autoimmune diseases, two assets which were licensed from
AstraZeneca to St George Street that is expected to be developed by us include AZD5904 (a Myeloperoxidase Inhibitor) targeting idiopathic
male infertility and AZD1656 (a Glucokinase Activator) targeting autoimmune diseases or immunodeficient conditions including uveitis,
premature labor, renal transplant rejection, and Hashimoto’s thyroiditis.
As
the clinical assets have undergone initial pre-clinical and clinical testing conducted by AstraZeneca, we are able to use the safety
data generated in these clinical trials to assess which clinical assets to further develop and for which indications.
Through
this relationship, there are considerable APIs that were manufactured by AstraZeneca in conducting its clinical trials available. As
a result, Conduit may not have to develop the APIs, which is often a time consuming and expensive process, and the APIs already produced
were subject to rigorous quality control measures.
Furthermore,
Conduit is well positioned, and intends, to pursue additional relationships and/or partnerships with third parties for the licensing
of further assets which are currently deprioritized. We plan to focus our efforts on developing clinical assets to address diseases that
impact a large population where there is no present treatment or the present treatment, carries significant unwanted side effects.
Key
Component of Result of Operations
Operating
Expenses
Research
and Development Expenses
Research
and development expenses consist primarily of costs incurred in connection with the research and development of our candidates and programs.
We expense research and development costs and intangible assets acquired that have no alternative future use as incurred. These expenses
include:
●
personnel-related
expenses, including salaries, bonuses, benefits and stock-based compensation for employees engaged in research and development functions;
●
expenses
incurred in connection with the clinical development and regulatory approval of our clinical assets, including under agreements with
third parties, such as consultants, contractors and CROs;
●
license
fees with no alternative use; and
●
other
expenses related to research and development.
We
expense research and development costs as incurred. Advance payments that we make for goods or services to be received in the future
for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the benefits are
consumed.
We
incurred approximately $128,000 on research and development activities during the three months ended March 31, 2024. There was no comparable research and development funding during
the three months ended March 31, 2023. Our research and development activities have been wholly focused on developing co-crystals of AZD1656
to increase patent life. Some of this work was completed by third-party CROs but all intellectual property is retained by us. We currently
have one pending international patent application and two pending national patent applications. The successful completion of clinical
trials increases the value of clinical assets and may lead to the commercialization and/or licensing of such assets to other pharmaceutical
companies. There is no assurance that any clinical trials on the assets owned or licensed by us will be successful.
General
and Administrative Expenses
General
and administrative expenses consist of salaries and other related costs, legal fees relating to intellectual property and corporate matters,
professional fees for accounting, auditing, tax and consulting services, insurance costs, travel, and other operating costs.
27
We
anticipate that our general and administrative expenses will increase substantially for the foreseeable future as we increase our administrative
headcount to operate as a public company and as we advance clinical assets through clinical development. We also will incur additional
expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the
SEC and the Nasdaq listing rules, additional insurance expenses, investor relations activities and other administrative and professional
services. In addition, if regulatory approval is obtained for clinical assets, we expect to incur expenses associated with building a
sales and marketing team.
Other
Income (Expenses)
Other
income (expenses), net
Other
income (expense), net consists of change in the fair value of options, change in fair value of convertible notes, and expense
incurred upon the issuance of warrants during the quarter. Other income (expense), net consists of change in the fair value of
options, change in fair value of convertible notes, and expense incurred upon the issuance of warrants during the
quarter.
Interest
expense, net
Interest
expense, net consists primarily of interest expense on convertible loan notes and promissory notes and interest expense on deferred commissions
payable to an advisor for fees related to the Merger, as well as a small amount of interest income on cash and cash equivalents held
by the Company.
Results
of Operations
The
following table set forth our results of operations for the periods indicated:
Three Months ended March 31,
(In thousands, except share and per share amounts)
2024
2023
Operating expenses:
Research and development expenses
$ 128
$ -
General and administrative expenses
2,827
1,515
Total operating costs and expenses
2,955
1,515
Operating loss
(2,955 )
(1,515 )
Other income (expenses):
Other income (expense), net
(487 )
(157 )
Interest Income
9
-
Interest expense, net
(119 )
-
Total other (expense) income, net
(597 )
(157 )
Net loss
$ (3,552 )
$ (1,672 )
Comparison
of the Three Months Ended March 31, 2024 and 2023
Research
and Development Expenses
Three Months ended March 31,
Change
(Dollar amounts in thousands)
2024
2023
Amount
%
Research and development expenses
$ 128
$ -
$ 128
100 %
Research
and development expenses increased by $0.1 million, or 100%, for the three months ended March 31, 2024, as compared to nil for the three
months ended March 31, 2023. The increase was primarily due to the development of certain co-crystals of AZD1656 (AZD1656 Co-Crystal PCT/IB2022/00075 - Patent Expires 02/09/2042) during the quarter
ended March 31, 2024. We will seek to develop the AZD1656 Co-Crystal in psoriasis, Crohn’s disease, lupus, sarcoidosis, diabetic
wound healing, idiopathic pulmonary fibrosis, and nonalcoholic steatohepatitis (NASH). There was no comparative activity during the three months ended March 31, 2023.
General
and Administrative Expenses
Three Months ended March 31,
Change
(Dollar amounts in thousands)
2024
2023
Amount
%
General and administrative expenses
$ 2,827
$ 1,515
$ 1,312
87 %
General
and administrative expenses increased by $1.3 million, or 87%, to $2.7 million for the three months ended March 31, 2024, as compared
to $1.5 million for the three months ended March 31, 2023. The increase was primarily driven by a $0.9 million increase in salaries and
stock compensation expense and $0.5 million increase in insurance related the amortization of D&O insurance, partially offset by
$0.2 million decrease in professional fees.
28
Other
Income (Expense), Net
Three Months ended March 31,
Change
(Dollar amounts in thousands)
2024
2023
Amount
%
Other income (expense), net
$ (487 )
$ (157 )
$ 330
210 %
Other
income (expense), net changed by $0.3 million, or 210%, to $0.5 million of expense for the three months ended March 31, 2024, as compared
to $0.2 million of net expense for the three months ended March 31, 2023. The increase was primarily driven by an increase of $0.5 million
related to the issuance of warrants during the three months ended March 31, 2024. The $0.2 million expense in for the three months ended March 31, 2023 was
primarily driven by a $0.3 million change in fair value on the convertible notes payable, partially offset by a gain of $0.1 million on the change in fair value of the Cizzle option.
For
further details refer to Note 13, “Other income (expense), net,” in the unaudited financial statements as of March 31, 2024
and March 31, 2023 included elsewhere in this Quarterly Report.
Interest
Expense, Net
Three Months ended March 31,
Change
(Dollar amounts in thousands)
2024
2024
Amount
%
Interest expense, net
$ (119 )
$ -
$ (119 )
-100 %
Interest
expense was $0.1 million for the three months ended March 31, 2024 compared to nil for the three months ended March 31, 2023. The change
was driven by $79 thousand of interest expense on the deferred commission payable to an advisor for fees related to the Merger and $40
thousand of interest expense for interest on convertible notes for the three months ended March 31, 2024.
Liquidity
and Capital Resources
Management
assesses liquidity in terms of our ability to generate cash to fund operating, investing and financing activities. Since our inception,
and in line with our growth strategy, we have prepared our financial statements assuming we will continue as a going concern. Since our
inception, we have incurred net losses and experienced negative cash flows from operations. To date, our primary sources of capital have
been through private placements of equity securities and convertible debt as well as PIPE financing as a result of the Merger. During
the three months ended March 31, 2024 and 2023, we had net losses of $3.6 million and $1.7 million, respectively. We
expect to incur additional losses and higher operating expenses for the foreseeable future as we continue to invest in research and development
programs. We have determined that additional financing will be required to fund our operations for the next 12 months and our ability
to continue as a going concern is dependent upon obtaining additional capital and financing.
Sources
and Uses of Liquidity
Our
primary uses of cash are to fund our operations as we continue to grow our business. We will require a significant amount of cash for
expenditures as we invest in ongoing research and development and business operations. Until such time as we can generate significant
revenue from commercialization of our product, we expect to finance our cash needs for ongoing research and development and business
operations through public or private equity or debt financings or other capital sources, including strategic partnerships. However, we
may be unable to raise additional funds or enter into such other arrangements, when needed, on favorable terms or at all. To the extent
that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders
will be, or could be, diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the
rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, or substantially
reduce research and development efforts. While the Company believes in the viability of its ability to raise additional funds, there
can be no assurances to that effect. These matters raise substantial doubt about the Company’s ability to continue as a going concern
for a period of twelve months from the date the financial statements are issued. These financial statements have been prepared assuming
the Company will continue as a going concern and do not include adjustments to reflect the possible effects on the recoverability and
classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
29
Cash
Requirements
Our
material cash requirements include the following contractual and other obligations.
Promissory
Convertible Note
In
March 2023, we issued an aggregate principal amount of $0.8 million convertible promissory note payable to an investor.
The
promissory convertible note matures and is payable in full, 18 months from the date of the note. The note carries 20% interest and is
payable every six months from the date of the note until the maturity date. The note is subject to conversion of Conduit’s common stock following
the consummation of the Merger taking place prior to the maturity date of the promissory convertible note.
Loans
Payable
In
May 2022, we entered into two loan agreements, with an aggregate principal amount of $0.2 million, with two lenders.
The
loans payable mature and is payable in full two years from the date of the agreement and bear no interest.
For
additional information regarding our convertible promissory note, see Note 7 of the note to the unaudited financial statements.
Working
Capital
We
currently anticipate that cash required for working capital for the next 12 months is approximately $14.4 million, which includes
deferred financing fees payable of $5.7 million, accrued expenses and other current liabilities of $0.9 million, a convertible
promissory note, if not converted prior to maturity, of $0.8 million, income taxes payable of $0.1 million and a note payable of
$0.2 million that matures within the next 12 months. We do not anticipate being able to fund required capital expenditures for the
next 12 months with cash and cash equivalents on hand as we have a history of limited cash on hand. We have historically been able
to access funds through the issuance of our convertible notes and believe we can continue to obtain funding through debt and equity financing agreements as needed to meet cash requirements for the next 12 months.
30
Cash
Flows
The
following table set forth our cash flows for the period indicated (in thousands):
Three Months ended March 31,
2024
2023
Net cash (used in) provided by:
Operating Activities
$ (2,357 )
$ (1,970 )
Investing Activities
-
(243 )
Financing Activities
-
2,220
Effect of exchange rate changes on cash and cash equivalents
(27 )
1
Net (decrease) increase in cash and cash equivalents
$ (2,384 )
$ 8
Cash
Flows Used in Operating Activities
Net
cash used in operating activities for the three months ended March 31, 2024, was $2.4 million, resulting primarily from a net loss of
$3.6 million, adjusted for non-cash items including a $0.4 million of stock-based compensation, a $0.4 million of amortization expense,
a $0.5 million expense on the issuance of warrants and a $0.1 million interest expense of the deferred commission payable. The $0.2 million
cash outflow from operating assets and liabilities is primarily due to a $0.1 cash inflow from accrued expense and other current liabilities
due to differences in the timing of disbursements and a $0.2 million cash outflow from prepaid expenses.
Net
cash used in operating activities for the three months ended March 31, 2023, was $1.9 million, resulting primarily from a net loss of
$1.7 million, adjusted for non-cash charges of $0.3 million for a loss on the change in fair value of convertible notes payable, a $0.2
million loss change in reserve on a related party loan, and a $0.1 million loss on the change in fair value of the Cizzle option. The
$0.7 million cash outflow from operating assets and liabilities is primarily due to a $0.2 cash outflow from accrued expense and other
current liabilities due to differences in the timing of disbursements and a $0.4 million cash outflow from prepaid expenses due to capitalized
costs incurred in connection with the Company’s Merger.
Cash
Flows (Used) Provided by Investing Activities
There was no
cash flow from investing activities for the three months ended March 31, 2024.
Net
cash used in investing activities for the three months ended March 31, 2023, was $0.3 million, resulting from the issuance
of a loan to a related party.
Cash
Flows Provided by Financing Activities
There
was no cash flow from financing activities for the three months ended March 31, 2024.
Net
cash provided by financing activities for the three months ended March 31, 2023, was $2.2 million, resulting from the issuance of a convertible
note payable of $1.4 million, and $0.7 million from the issuance of a convertible promissory note payable.
Contractual
Obligations and Other Commitments
As
of March 31, 2024, we had no non-cancellable commitments for the purchase of clinical materials, contract manufacturing, maintenance
and committed funding which we expect to pay within one year.
31
Critical
Accounting Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that affect
the amounts reported in the Consolidated Financial Statements. These estimates, judgments and assumptions are evaluated on an ongoing
basis. We base our estimates on historical experience and on various other assumptions that we believe are reasonable at that time, 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 materially from those estimates. The accounting policies that reflect our more significant
estimates, judgments and assumptions and which we believe are the most critical to aid in fully understanding and evaluating our reported
financial results include the following:
Going
Concern
The
accompanying Consolidated Financial Statements have been prepared on a going concern basis of accounting, which contemplates continuity
of operations, realization of assets and liabilities and commitments in the normal course of business. The accompanying Consolidated
Financial Statements do not reflect any adjustments that might result if we are unable to continue as a going concern. In connection
with the preparation of the Consolidated Financial Statements for the three months ended March 31, 2024 and year ended December 31, 2023,
we conducted an evaluation as to whether there were conditions and events, considered in the aggregate, which raised substantial doubt
as to our ability to continue as a going concern within one year after the date of the issuance of such financial statements, and concluded
that substantial doubt existed as to our ability to continue as a going concern as further discussed in Note 1 in the notes to the Consolidated
Financial Statements of this Quarterly Report.
Under
ASC 205-40, the receipt of potential funding from future partnerships, equity or debt issuances, potential achievement of milestones
from customer agreements and reductions in workforce cannot be considered probable at this time because these plans are not entirely
within our control and/or have not been approved by our board of directors as of the date of issuance of the Consolidated Financial Statements.
Our
expectation to generate operating losses and negative operating cash flows in the future and the need for additional funding to support
our planned operations, raise substantial doubt regarding our ability to continue as a going concern. Our plans to alleviate the conditions
that raise substantial doubt include reduced spending, and the pursuit of additional capital. We have concluded the likelihood that our
plan to successfully obtain sufficient funding from one or more of these sources, or adequately reduce expenditures, while possible,
is less than probable. We believe that the accounting estimates described below involve a significant degree of judgment and complexity.
Accordingly, we believe these are the most critical to aid in fully understanding and evaluating our financial condition and results
of operations.
Fair
Value Measurements
Accounting
Standards Codification (“ASC”) Topic 820, Fair Value Measurements and Disclosures , defines fair value, establishes
a framework for measuring fair value, and expands disclosures about fair value measurements. Fair value is to be determined based on
the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants. In determining fair value, the Company used
various valuation approaches. A fair value hierarchy has been established for inputs used in measuring fair value that maximizes the
use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available.
Observable inputs are those that market participants would use in pricing the asset or liability based on market data obtained from sources
independent of the Company.
Unobservable
inputs reflect the Company’s assumption about the inputs that market participants would use in pricing the asset or liability developed
based on the best information available in the circumstances. The fair value hierarchy is categorized into three levels, based on the
inputs, as follows:
●
Level
1-Valuations based on quoted prices for identical instruments in active markets. Since valuations are based on quoted prices that
are readily and regularly available in an active market, valuation of these instruments does not entail a significant degree of judgment.
32
●
Level
2- Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for either similar instruments
in active markets, identical or similar instruments in markets that are not active, or model-derived valuations whose inputs or significant
value drivers are observable or can be corroborated by observable market data.
●
Level
3-Valuations based on inputs that are unobservable. These valuations require significant judgment.
The
Company’s Level 1 assets consist of cash and cash equivalents in the accompanying balance sheets and the value of accrued expenses
and other current liabilities approximate fair value due to the short-term nature of these assets and liabilities.
As
of March 31, 2024, the Company has one financial liability, a warrant liability for which the fair value is determined based on Level
2 inputs as such inputs are based on observable inputs other than quoted prices.
The warrant liability is valued using a Black-Scholes model, with the most judgmental non-observable input being
the volatility measure. Changes in the assumptions around the volatility can cause significant changes in the estimated fair value of
the warrant liability. See Note 4 for further information on the Company’s financial liabilities carried at fair value.
Emerging
Growth Company Status and Smaller Reporting Company Status
The
Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under
the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of
the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period
for complying with new or revised accounting standards that have different effective dates for public and private companies until the
earlier of the date that: (i) is no longer an emerging growth company or (ii) affirmatively and irrevocably opts out of the extended
transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with
the new or revised accounting pronouncements as of public company effective dates.
Upon
closing of the Merger, the surviving company remained an emerging growth company, as defined by the Jumpstart Our Business Startups act
of 2012, until the earliest of (i) the last day of the combined entity’s first fiscal year following the fifth anniversary of the
completion of MURF’s initial public offering, (ii) the last day of the fiscal year in which the combined entity has total annual
gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which the combined entity is deemed to be a large
accelerated filer, which means the market value of the combined entity’s common stock that is held by non-affiliates exceeds $700.0
million as of the prior December 31st or (iv) the date on which the combined entity has issued more than $1.0 billion in non-convertible
debt securities during the prior three year period.
33
In
addition, Conduit is a smaller reporting company as defined in the Exchange Act. The Company may continue to be a smaller reporting company
even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller
reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) Conduit’s voting and non-voting
common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii)
Conduit’s annual revenue is less than $100.0 million during the most recently completed fiscal year and its voting and non-voting
common stock held by non-affiliates is less than $700.0 million measured on the last business day of its second fiscal quarter.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
As a smaller reporting company, we are not required to provide disclosure regarding quantitative and qualitative
market risk.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.