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REVIEW AND PROSPECTS
You should read the following discussion of our financial condition
and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this Annual Report
on Form 20-F. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results
could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences
include those discussed below and elsewhere in this Annual Report on Form 20-F, particularly those in “Item 3. Key Information -
Risk Factors.” Our discussion and analysis for the year ended December 31, 2024 can be found in Item 5. “Operating and Financial
Review and Prospects” of our Annual Report on Form 20-F for the fiscal year ended December 31, 2024, filed with the SEC on March
31, 2025 (File No. 001-35223).
We are a biopharmaceutical company pursuing life-changing therapies
in oncology and rare diseases. Our first approved product, APHEXDA® (motixafortide), a novel peptide for the treatment of stem-cell
mobilization and solid tumors, with an indication in the United States for stem cell mobilization for autologous transplantation
in multiple myeloma, is being developed and commercialized by Ayrmid Pharma Ltd., or Ayrmid, (globally, excluding Asia) and Gloria, (in
Asia). We are also advancing the development of motixafortide for patients with pancreatic cancer and other solid tumors outside of Asia.
In October 2023, we out-licensed the rights to motixafortide for
all indications in substantially all of Asia to Gloria, and in November 2024, we out-licensed the global rights (other than in Asia) to
motixafortide for all indications, other than solid tumors, to Ayrmid. As a result of the November 2024 transaction, we shut down our
independent commercialization activities in the United States and refocused our operations on development activities in Israel in the
fields of oncology (including solid tumors) and rare diseases, at a significantly reduced annual cash burn rate.
We have retained the rights to develop motixafortide across all solid tumor indications,
in all territories other than Asia, including in PDAC, for which an investigator-initiated Phase 2b trial, sponsored by Columbia University,
and supported equally by us and Regeneron, is ongoing at a relatively minimal cost to us. We expect this program to continue to advance
without any significant expense to us.
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In September 2025, we entered into a collaboration transaction with Hemispherian AS,
or Hemispherian, a Norwegian biotech company focused on small molecule cancer therapeutics, for the development, clinical evaluation
and commercialization of GLIX1, Hemispherian’s lead drug candidate, a first-in-class, oral, small molecule targeting DNA damage
response in GBM, and other cancers.
A key pillar of our growth strategy is to in-license additional
assets in the fields of oncology and rare diseases – areas where significant unmet medical needs remain and where innovative therapies
can have a transformative impact on patient lives. We are committed to identifying and advancing therapeutic candidates that demonstrate
clear differentiation from currently available treatments, offering the potential for superior efficacy, improved safety, and novel mechanisms
of action. We have generated our pipeline through a systematic process of asset identification, rigorous scientific and clinical validation,
and disciplined in-licensing. We believe this methodical approach allows us to select candidates with a high probability of both therapeutic
and commercial success. Drawing on our substantial experience in asset scouting and evaluation and executing transactions structured with
back-ended, success-based consideration, we are seeking to secure assets with modest upfront payments, while aligning incentives with
our partners and maintaining a focus on cost-effective clinical development programs. With our deep expertise, strategic focus, and prudent
financial management, we believe we are uniquely positioned to bring forward novel therapies that can redefine standards of care and deliver
significant value to patients, healthcare providers, and stakeholders.
Our longer-term vision is to develop innovative assets with significant
potential value whose development costs have been offset by the royalties and milestones from our existing motixafortide partnerships.
We aim to continue pursuing new partnerships on these programs to create additional value for our shareholders.
A. Operating Results
History of Losses
Since our inception in 2003, we have generated significant losses.
As of December 31, 2025, we had an accumulated deficit of $401 million. We expect to continue to generate losses in connection with our
research and development activities relating to our pipeline of therapeutic candidates until we reach commercial profitability, if ever.
Such research and development activities are budgeted to expand over time and will require further resources if we are to be successful.
As a result, we expect to continue to incur operating losses and we expect to need to obtain additional funds to further pursue our research
and development programs.
We have funded our operations primarily through the sale of equity
securities (both in public and private offerings), payments received under our strategic licensing and collaboration arrangements, funding
received from the Israel Innovation Authority, or IIA, debt financing, and interest earned on investments. We expect to continue to fund
our operations over the next several years through our existing cash resources, potential future milestone and royalty payments that we
may receive from our existing out-licensing agreements, primarily royalties from the commercialization of APHEXDA by Ayrmid, potential
future upfront, milestone or royalty payments that we may receive from Gloria and any other out-licensing transaction, interest earned
on our investments, and additional capital to be raised through public or private equity offerings or debt financings. As of December
31, 2025, we had $20.9 million of cash, cash equivalents and short-term bank deposits.
Revenues
Our revenues to date have been generated primarily from upfront
and milestone payments under out-licensing agreements and between the fourth quarter of 2023 and November 2024, and revenues from product
sales of APHEXDA.
We expect our revenues, if any, for the next several years to be
derived primarily from future royalties on product sales, primarily royalties paid by Ayrmid from the commercialization of APHEXDA in
stem cell mobilization in the U.S. and potential milestone payments from the license agreements with Ayrmid and Gloria.
Cost of Revenues
Our cost of revenues to date have consisted of sub-license payments
to the licensors in respect of upfront and milestone payments associated with out-licensing agreements, costs associated with the manufacture
of APHEXDA and royalty payments to the licensor with respect to direct product sales of APHEXDA. Prior to receiving FDA approval for APHEXDA
in September 2023, we expensed all manufacturing and material costs as research and development expenses.
We expect our cost of revenues, if any, for the next several years
to be derived primarily from sub-license payments to the licensors in respect of out-licensing agreements and other potential collaboration
arrangements, including future royalties on product sales from such out-licensing agreements.
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Research and Development
Our research and development expenses consist primarily of salaries
and related personnel expenses, fees paid to external service providers, up-front and milestone payments under our license agreements,
patent-related legal fees, costs of preclinical studies and clinical trials, drug and laboratory supplies and costs for facilities and
equipment. We primarily use external service providers to manufacture our therapeutic candidates for clinical trials and for the majority
of our preclinical and clinical development work. We charge all research and development expenses to operations as they are incurred.
We expect our research and development expenses to remain one of our primary expenses in the near future as we continue to develop GLIX1,
motixafortide and additional assets we may in license.
The following table identifies our current major research and development projects:
Project Status Expected Near Term Milestones
GLIX1 1. IND cleared by the FDA in August 2025; preparations ongoing for upcoming initiation of Phase 1/2a study in GBM and other cancers 1. Phase 1/2a study expected to initiate in Q1 2026
Motixafortide 2. FDA approval received on September 8, 2023 for stem-cell mobilization in multiple myeloma patients. 2. Out-licensed to Ayrmid in November 2024; five-year long-term follow-up of GENESIS patients ongoing
3. Reported preliminary data in September 2023 from single-arm pilot phase of the investigator-initiated Phase 2 combination trial in first-line PDAC. Of 11 patients with metastatic pancreatic cancer enrolled, 7 patients (64%) experienced partial response (PR), of which 6 (55%) were confirmed PRs with one patient experiencing resolution of the hepatic (liver) metastatic lesion. 3 patients (27%) experienced stable disease, resulting in a disease control rate of 91%. Based on these encouraging preliminary results, study was substantially revised to a multi-institution, randomized Phase 2b trial of 108 patients. In May 2025, reported updated results from the pilot phase indicating that four of 11 patients remained progression free after more than one year. Two patients underwent definitive treatment for mPDAC – one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response. An analysis of pre- and on-treatment biopsies and peripheral blood mononuclear cells (PBMCs) also revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. 3. First patient dosed in randomized study in February 2024. Interim futility analysis planned for 2026 and full enrollment projected for 2027*
4. Phase 1 study for gene therapies in SCD (with Washington University School of Medicine in St. Louis)**, which was initiated in December 2023 4. Study completed during 2025. Final results from the study were presented at ASH Annual Meeting in December 2025. A summary of the published abstract is disclosed in this report above – see “Motixafortide”, “Stem cell mobilization”, “Sickle Cell Disease”
5. Phase 1 study for gene therapies in SCD (with St. Jude Children’s Research Hospital, Inc.)** 5. First patient dosed in February 2025, with data planned in 2026*
6. IND approved in China for initiation of pivotal bridging study in SCM under license agreement with Gloria 6. First patient dosed in December 2025
7. Phase 2b randomized study in first-line PDAC in China under license agreement with Gloria 7. IND submission and protocol finalization is currently delayed***
* These studies are investigator-initiated studies; therefore, the timelines are ultimately controlled by the independent investigators and are subject to change.
** Study to be continued under the Ayrmid License Agreement
*** The planned study of motixafortide in China under the Gloria License Agreement is currently not advancing according to schedule and it is unclear when such study will be initiated, if at all.
We expect that a large percentage of our research and development
expenses in the future will be incurred in support of our current and future clinical and pre-clinical development projects. Clinical
development timelines, the probability of success and development costs can differ materially from expectations. We expect to continue
to test GLIX1, motixafortide and any other therapeutic candidates in preclinical studies for toxicology, safety and efficacy, and to conduct
additional clinical trials for each such candidate. If we are not able to enter into an out-licensing arrangement with respect to any
therapeutic candidate prior to the commencement of later stage clinical trials, we may fund the trials for the therapeutic candidate ourselves.
Our future research and development expenses will depend on the
clinical success of GLIX1, motixafortide (in solid tumor indications) and on other potential therapeutic candidates, as well as ongoing
assessments of each therapeutic candidate’s commercial potential. In addition, we cannot forecast with any degree of certainty which
therapeutic candidates may be subject to future out-licensing arrangements, when such out-licensing arrangements will be secured, if at
all, and to what degree such arrangements would affect our development plans and capital requirements.
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As we obtain results from clinical trials, we may elect to discontinue
or delay clinical trials for certain therapeutic candidates or projects in order to focus our resources on more promising therapeutic
candidates or projects. Completion of clinical trials by us or our licensees may take several years or more, but the length of time generally
varies according to the type, complexity, novelty and intended use of a therapeutic candidate.
The cost of clinical trials may vary significantly over the life
of a project as a result of differences arising during clinical development, including, among others:
• the number of sites included in the clinical trials;
• the length of time required to enroll suitable patients;
• the number of patients that participate, and are eligible to participate, in the clinical trials;
• the duration of patient follow-up;
• whether the patients require hospitalization or can be treated on an outpatient basis;
• the development stage of the therapeutic candidate; and
• the efficacy and safety profile of the therapeutic candidate.
The lengthy process of completing clinical trials and seeking regulatory
approval for our therapeutic candidates requires expenditure of substantial resources. Any failure or delay in completing clinical trials,
or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses
to increase and, in turn, have a material adverse effect on our operations. Due to the factors set forth above, we are not able to estimate
with any certainty when we would recognize any net cash inflows from our projects.
Sales and Marketing Expenses
In 2023 and 2024, sales and marketing expenses consisted primarily
of compensation for employees in commercialization, marketing and business development functions. Other significant costs included
marketing and communication materials, market access activities, professional fees for outside market research and consulting, and legal
services related to compliance and to potential business development transactions.
Following the license agreement with Ayrmid and the termination
of our commercialization activities in the U.S., we experienced a significant reduction in sales and marketing expenses and, during the
year ended December 31, 2025, we did not incur any sales and marketing expenses. We expect that any future sales and marketing expenses
will be primarily related to business development.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation
for employees in executive and operational functions, including accounting, finance, legal, investor relations, information technology,
and human resources. Other significant general and administration costs include facilities costs, professional fees for outside accounting
and legal services, travel costs, insurance premiums, depreciation and a provision for doubtful accounts receivable when relevant.
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Non-Operating Expense and Income
Non-operating expense and income includes fair-value adjustments
of liabilities on account of the warrants issued in equity financings we carried out in February 2019, September 2022 April 2024, November
2024 and January 2025. These fair-value adjustments are highly influenced by our share price at each period end (revaluation date). Non-operating
expense and income also includes issuance expenses under the “at-the-market” offering agreement, or ATM Agreement, between
us and HCW entered into in September 2021, and the pro-rata share of issuance expenses from the placements related to the warrants. Net
sales-based royalties from the license agreement with Perrigo have also been included as part of non-operating income, as the out-licensed
product is not an integral part of our strategy, and the amounts are not material.
Financial Expense and Income
Financial expense and income consist of interest earned on our
cash, cash equivalents and short-term bank deposits; interest expense related to our loans from BlackRock, bank fees and other transactional
costs. In addition, it may also include gains/losses on foreign exchange hedging transactions, which we carry out from time to time to
protect against a portion of our NIS-denominated expenses (primarily compensation) in relation to the dollar.
Critical Accounting Policies and Estimates
Our consolidated financial statements are prepared in conformity
with IFRS, as issued by the IASB. In preparing our consolidated financial statements, we make judgements, estimates and assumptions about
the application of our accounting policies which affect the reported amounts of assets, liabilities, revenue and expenses. Our critical
accounting judgements and sources of estimation uncertainty are described in Note to our consolidated financial statements, which are
included elsewhere in this Annual Report on Form 20-F.
Impairment
of indefinite-lived intangible assets
We perform impairment reviews of intangible assets not subject
to amortization on an annual basis, or more frequently if events or changes in circumstances indicate a potential impairment.
The recoverable amount is determined using discounted cash flow calculations. The analysis
estimates the future cash flows we expect to derive from the asset, incorporates expectations about possible variations in the amount
or timing of those future cash flows, as well as the uncertainty inherent in the asset, and the risk-adjusted cash flows are then discounted
using our estimated post-tax weighted average cost of capital, or WACC. The main estimates used in calculating the recoverable amount
include the WACC estimation and the amounts and timing of projected future cash flows. Such amounts and timing are influenced by the expected
outcome of development activities, the probability of success and timing in gaining regulatory approval, size of the potential market
and our specific market share, either via direct sales or a potential out-licensing deal.
Accrued Expenses
We are required to estimate accrued expenses as part of our process
of preparing financial statements. This process involves estimating the level of service performed on our behalf and the associated cost
incurred in instances where we have not been invoiced or otherwise notified of actual costs. Examples of areas in which subjective judgments
may be required include costs associated with services provided by contract organizations for commercialization, clinical trials, and
preclinical development. We account for expenses associated with these external services by determining the total cost of a given study
based on the terms of the related contract. We accrue for costs incurred as the services are being provided by monitoring the status of
the trials and the invoices received from our external service providers. In the case of clinical trials, the estimated cost normally
relates to the projected costs of treating the patients in our trials, which we recognize over the estimated term of the trial according
to the number of patients enrolled in the trial on an ongoing basis, beginning with patient enrollment. As actual costs become known to
us, we adjust our accruals.
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Investments in Financial Assets
The primary objective of our investment activities is to preserve
principal while maximizing the income that we receive from our investments without significantly increasing risk and loss. Our investments
are exposed to market risk due to fluctuations in interest rates, which may affect our interest income and the fair market value of our
investments. We manage this exposure by performing ongoing evaluations of our investments. Due to the short-term maturities of our investments
to date, their carrying value has always approximated their fair value.
A financial asset is classified in this category if our management
has designated it as a financial asset upon initial recognition, because it is managed, and its performance is evaluated, on a fair-value
basis in accordance with a documented risk management or investment strategy. Our investment policy with regard to excess cash, as adopted
by our board of directors, is composed of the following objectives: (i) preserving investment principal; (ii) providing liquidity; and
(iii) providing optimum yields pursuant to the policy guidelines and market conditions. The policy provides detailed guidelines as to
the securities and other financial instruments in which we are allowed to invest. In addition, in order to maintain liquidity, investments
are structured to provide flexibility to liquidate at least 50% of all investments within 15 business days. Information about these assets,
including details of the portfolio and income earned, is provided internally on a quarterly basis to our key management personnel and
on a semi-annual basis to the Investment Monitoring Committee of our board of directors. Any divergence from this investment policy requires
approval from our board of directors.
Share-based Compensation
We account for share-based compensation arrangements in accordance
with the provisions of IFRS 2. IFRS 2 requires companies to recognize share compensation expense for awards of equity instruments based
on the grant-date fair value of those awards (with limited exceptions). The cost is recognized as compensation expense over the life of
the instruments, based upon the grant-date fair value of the equity or liability instruments issued. The fair value of our share-based
compensation grants is computed as of the grant date based on the Black-Scholes model, using the standard parameters established in that
model including estimates relating to volatility of our shares/ADSs, risk-free interest rates, estimated life of the equity instruments
issued and the market price of our shares/ADSs. As our ordinary shares/ADSs are publicly traded on the TASE or Nasdaq, we do not need
to estimate their fair market value. Rather, we use the actual closing market price of our ordinary shares/ADSs on the date of grant,
as reported by the TASE or Nasdaq.
Warrants
In connection with a loan transaction entered into with BlackRock
in October 2018, we issued a warrant to purchase 1,596 ADSs at an exercise price of $564.00 per ADS. The warrant is exercisable for a
period of ten years from the date of issuance. Since the exercise price was not deemed to be fixed, the warrant is not qualified for classification
as an equity instrument and has therefore been classified as a non-current financial liability.
In connection with an underwritten public offering we completed
in January 2021, we issued warrants to purchase 17,989 ADSs at an exercise price of $120.00 per ADS. The warrants are exercisable for
a period of five years from the date of issuance. The warrants have been classified as shareholder’s equity and expired January
2026.
In connection with a registered direct offering we completed in
September 2022, we issued warrants to purchase 340,909 ADSs at an exercise price of $46.00 per ADS, of which warrants to purchase 63,637
have been exercised. The warrants are exercisable for a period of five years from the date of issuance. Since the exercise price of those
warrants were not deemed to be fixed, the warrants are not qualified for classification as an equity instrument and have therefore been
classified as a non-current financial liability. We also issued warrants to purchase 17,045 ADSs at an exercise price of $55.00 per ADS.
The warrants are exercisable for a period of five years from the date of issuance and have been classified as shareholder’s equity.
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In connection with a registered direct offering we completed in
April 2024, we issued warrants to purchase 187,500 ADSs at an exercise price of $32.00 per ADS, of which none of these warrants have been
exercised to date. The warrants are exercisable for a period of five years from the date of issuance. Since the exercise price of those
warrants were not deemed to be fixed, the warrants are not qualified for classification as an equity instrument and have therefore been
classified as a non-current financial liability.
In connection with a registered direct offering we completed in
November 2024, we issued warrants to purchase 205,893 ADSs at an exercise price of $23.60 per ADS, of which none of these warrants have
been exercised to date, and pre-funded warrants to purchase 308,749 ADSs at an exercise price of $0.004 per ADS, of which warrants to
purchase 124,982 have been exercised. The warrants are exercisable for a period of four years from the date of issuance and the pre-funded
warrants will not expire until exercised in full. Since the exercise price of the warrants were not deemed to be fixed, the warrants are
not qualified for classification as an equity instrument and have therefore been classified as a non-current financial liability. The
pre-funded warrants have been classified as equity instruments.
In connection with a registered direct offering we completed in
January 2025, we issued warrants to purchase 1,250,000 ADSs at an exercise price of $8.00 per ADS, of which none of these warrants have
been exercised to date, and pre-funded warrants to purchase 391,697 ADSs at an exercise price of $7.996 per ADS, of which all of the warrants
had been exercised. The warrants are exercisable for a period of five years from the date of issuance and the pre-funded warrants will
not expire until exercised in full. We also issued placement agent warrants to purchase 62,500 ADSs at an exercise price of $10.00 per
ADS. The warrants are exercisable for a period of five years from the date of issuance. Since the exercise price of the warrants were
not deemed to be fixed, the warrants are not qualified for classification as an equity instrument and have therefore been classified as
a non-current financial liability. The pre-funded warrants have been classified as equity instruments.
Results of Operations - Overview
Comparison of the Year Ended December 31, 2025 to the Year Ended
December 31, 2024
Revenues
Revenues for the year ended December 31, 2025 were $1.2 million,
a decrease of $27.7 million, compared to $28.9 million for the year ended December 31, 2024. The significant decrease in revenues in 2025
from 2024 reflects the one-time revenues recorded in 2024 relating to the out-licensing transaction with Gloria during the fourth quarter
of 2023, as well as the change in our operations following the out-licensing of APHEXDA to Ayrmid during the fourth quarter of 2024.
The revenues in 2025 reflect the royalties paid by Ayrmid from
the commercialization of APHEXDA in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect a portion of the up-front
payment received by us under the Gloria License Agreement and a milestone payment achieved under the Gloria License Agreement, which collectively
amounted to $15.0 million, as well as the up-front payment received by us under the Ayrmid License Agreement and $6.0 million of net revenues
from product sales of APHEXDA in the United States.
Cost of revenues
Cost of revenues for the year ended December 31, 2025 were $0.2
million, a decrease of $9.1, compared to $9.3 million for the year ended December 31, 2024. The cost of revenues in 2025 reflects sub-license
fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024
primarily reflects the amortization of intangible assets, sub-license fees on the up-front payment received by us for the Ayrmid License
Agreement, sub-license fees accrued on a milestone payment recorded under the Gloria License Agreement, as well as royalties on net product
sales of APHEXDA in the U.S. and cost of goods sold on product sales.
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Research and development expenses
Research and development expenses for the year ended December 31, 2025 were $8.1 million,
a decrease of $1.1 million, or 11.5% compared to $9.2 million for the year ended December 31, 2024. The decrease resulted primarily from
lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based
compensation, primarily due to a decrease in headcount, offset by expenses related to initiation of the GLIX1 project.
Sales and marketing expenses
There were no sales and marketing expenses in 2025 compared to $23.6 million for the
year ended December 31, 2024. The decrease resulted from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following
the Ayrmid out-licensing transaction.
General and administrative expenses
General and administrative expenses for the year ended December
31, 2025 were $3.1 million, a decrease of $3.2 million, or 50.3% compared to $6.3 million for the year ended December 31, 2024. The decrease
resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria,
as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, and a decrease in a number of
general and administrative expenses.
Impairment of intangible assets
We did not record an impairment of intangible assets in 2025, compared
to a $1.0 impairment of intangible assets for the year ended December 31, 2024. This non-cash expense in 2024 reflects the impairment
of the remaining rights related to motixafortide in solid tumor indications.
Non-operating income (expense), net
We recognized net non-operating income of $8.1 million for the
year ended December 31, 2025 compared to net non-operating income of $18.4 million for the year ended December 31, 2024. Non-operating
income for the periods primarily relates to fair-value adjustments of warrant liabilities on our balance sheet, as a result of changes
in our share price, offset by warrant offering expenses.
Financial income (expense), net
We recognized net financial income of $0.2 million for the year
ended December 31, 2025 compared to net financial expenses of $7.3 million for the year ended December 31, 2024. Net financial income
for 2025 relates to investment income earned on our bank deposits and gains on foreign currency (primarily NIS) cash balances due to the
appreciation of the NIS against the U.S. dollar during the period, partially offset by interest paid on loans. Net financial expenses
for 2024 primarily relate to interest paid on loans, which increased in 2024 due to a one-time $4.0 million charge to interest expense
in connection with the November 2024 amendment to our loan agreement with BlackRock (as described in Note 10 to our consolidated financial
statements), partially offset by investment income earned on our bank deposits.
B. Liquidity and Capital Resources
Since our inception, we have funded our operations primarily through
public and private offerings of our equity securities, payments received under our strategic licensing and collaboration arrangements,
interest earned on investments, debt financing and funding previously received from the IIA. As of December 31, 2025, we held $20.9
million of cash, cash equivalents and short-term bank deposits. We have invested substantially all our available cash funds in short-term
bank deposits.
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In September 2021, we entered into the ATM Agreement with HCW pursuant
to which we may offer and sell, at our option, up to $25.0 million of our ADSs through an at-the-market equity program under which HCW
agreed to act as sales agent. As of the issuance date of this report, we have sold 825,010 of our ADSs for total gross proceeds of approximately
$9.6 million under the ATM program. Under General Instruction I.B.5 to Form F-3 (also known as the baby shelf rule), we may currently
sell up to $4.5 million under the ATM program.
Loan Agreements with BlackRock
In September 2022, we entered into a secured Loan Agreement with
BlackRock EMEA Venture and Growth Lending (previously Kreos Capital VII Aggregator SCSP), or BlackRock, under which BlackRock agreed to
provide us with access to term loans in an aggregate principal amount of up to $40 million in three tranches, or the Loans. We drew down
the initial tranche of $10 million following execution of the agreement in September 2022 and we drew down the second tranche of $20 million
in April 2024, following fulfilment of the requisite milestones. The third tranche was available for drawdown until October 1, 2024, upon
achievement of certain milestones, but was not drawn down.
In November 2024, in connection with the Ayrmid License Agreement,
we entered into the Loan Amendment to the Loan Agreement with BlackRock, pursuant to which, (i) we agreed to make aggregate payments of
$16.5 million, as partial repayment of the Loans and in lieu of future revenue-based payments, which were fully cancelled, (ii) effective
December 1, 2024, we agreed to pay the remaining amounts outstanding under the Loans (in principal and interest) over a three year period
ending December 1, 2027, and (iii) our minimum cash balance requirement under the Loan Agreement was reduced from $10 million to $4 million.
In addition, pursuant to the Loan Amendment, 10% of any future milestone payments received by us from the out-licensing agreements through
December 1, 2027 will be used to repay principal of the Loans, and the repayments in (ii) above will be adjusted accordingly. All other
terms of the Loan Agreement remain the same.
Interest on each tranche of the Loans accrues at a fixed rate of
9.5% per annum from the drawdown date until repayment in full of the tranche.
We may prepay all, but not less than all, of the outstanding balance
of any of the Loans. In connection with any prepayment, we will also pay an end of loan payment equal to 5% of the amount of each tranche
drawn down upon the final repayment of each such tranche, or the End of Loan Payment, and any other unpaid fees or costs, if any.
The Loans are subject to mandatory accelerated repayment provisions
that require repayment of the outstanding principal amount of the Loans, and all accrued and unpaid interest thereon, upon the occurrence
of an event of default, subject to certain limitations and cure rights. In addition, in the event of acceleration upon an event of default
(a) we will be required to pay the aggregate of the monthly interest payments scheduled to be paid by the Company for the period from
the date of acceleration to the expiry of the applicable Loan, in each case discounted from the applicable monthly repayment date to the
date of prepayment at the rate of 2% per annum and (b) the End of Loan Payment.
Outstanding borrowings under the Loan Agreement are secured by
(a) a first priority fixed charge over certain assets and intellectual property of the Company, as well as all shares held by the Company
in BioLineRx USA, Inc., or the Fixed Charge, (b) a first priority floating charge over all our assets as of the date of the Loan Agreement
or thereafter acquired, other than the assets charged under the Fixed Charge or as otherwise specifically excluded pursuant to the terms
of the floating charge, and (c) subject to the provisions of the Fixed Charge, a security interest in our intellectual property.
The Loan Agreement contains customary representations and warranties,
indemnification provisions in favor of the Lender, events of default and affirmative and negative covenants, including, among others,
covenants that limit or restrict the Company’s ability to, among other things, incur additional indebtedness, merge or consolidate,
make acquisitions, pay dividends or other distributions or repurchase equity, and dispose of assets, in each case subject to certain exceptions.
The Company has also granted BlackRock certain information rights.
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Cash Flows
Net cash used in operating activities was $8.1 million for the
year ended December 31, 2025, compared with net cash used in operating activities of $43.9 million for the year ended December 31, 2024.
The $35.8 million decrease in net cash used in operating activities in 2025 was primarily the result of a significant decrease
in operating expenses following the transaction with Ayrmid in the fourth quarter of 2024.
Net cash used in investing activities was $8.6 million for the
year ended December 31, 2025, compared to net cash provided by investing activities of $29.4 million for the year ended December 31, 2024.
The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits.
Net cash provided by financing activities was $8.9 million for
the year ended December 31, 2025, compared to net cash provided by financing activities of $20.7 million for the year ended December 31,
2024. The net cash provided by financing activities in 2025 primarily reflects the net proceeds of the registered direct offering and
net proceeds from the ATM facility, offset by repayments of the loan from BlackRock and the repayments of lease liabilities. Net
cash provided by financing activities in 2024 primarily reflects the net proceeds of a loan from BlackRock and the net proceeds of a registered
direct offering of our ADSs in April 2024, offset by repayments of the loan from BlackRock and the repayments of lease liabilities.
Funding Requirements
We have incurred
accumulated losses in the amount of $401 million through December 31, 2025, and we expect to continue incurring losses and negative cash
flows from operations until the cash flows from our strategic partnerships and collaborations reach a level to offset our ongoing development
costs. In this regard, management monitors rolling forecasts of our liquidity reserves on the basis of anticipated cash flows and seeks
to maintain liquidity balances at levels that are sufficient to meet its needs. Our cash flow projections are subject to various risks
and uncertainties concerning their fulfilment, and these factors and the risk inherent in our operations, which management has concluded
indicate that a material uncertainty exists, may cast significant doubt on our ability to continue as a going concern. Similarly, our
independent registered public accounting firm included a “going concern” explanatory paragraph in its report on our financial
statements as of and for the year ended December 31, 2025.
Developing drugs and conducting clinical trials is expensive and
we will need to raise substantial additional funds to achieve our strategic objectives. Based on our current projected cash requirements,
we believe that our existing cash and investment balances and other sources of liquidity, including royalties received from Ayrmid from
product sales of APHEXDA and milestone payments from our license agreements with Ayrmid and Gloria, will be sufficient to meet our capital
requirements into the first half of 2027. We expect to also continue to seek to finance our operations through other sources, including
out-licensing arrangements for the development and commercialization of our therapeutic candidates or other partnerships or collaborations,
public and private offerings of our equity securities, as well as grants from government agencies and foundations. Our future capital
requirements will depend on many factors, including:
• the progress and costs of our preclinical studies, clinical trials and other research and development activities;
• the scope, prioritization and number of our clinical trials and other research and development programs;
• the amount of revenues we receive, if any, under our collaboration or licensing arrangements;
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• the costs of the development and expansion of our operational infrastructure;
• the costs and timing of obtaining regulatory approval of our therapeutic candidates;
• our success in effecting out-licensing arrangements with third parties;
• the ability of our collaborators and licensees to achieve development milestones, marketing approval and other events or developments under our collaboration and out-licensing agreements;
• the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
• the costs and timing of securing manufacturing arrangements for clinical or commercial production;
• the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us;
• the costs of acquiring or undertaking development and commercialization efforts for any future therapeutic candidates;
• the magnitude of our general and administrative expenses;
• interest and principal payments on the loan from BlackRock;
• any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates; and
• market conditions.
If funds are not available, we may be required to delay, reduce the scope of, or eliminate
one or more of our research or development programs.
Contractual Obligations
We are party to contractual obligations involving commitments to make payments to third
parties. Our contractual obligations primarily consist of lease payments, a commitment to invest in Tetragon and purchase order obligations.
Premises leasing obligations represent our commitment for future lease payments under the lease agreement for our facilities in Modi’in,
Israel. The total future payments for our premises leasing obligations on December 31, 2025 were approximately $1.6 million which is due
through June 2030. Purchase order obligations amounted to $2.4 million as of December 31, 2025. Under the Collaboration Agreement, we
agreed to invest $5 million in Tetragon over 36 months (beginning September 2025) in tranches according to a development plan (subject
to extension for an additional six months in certain circumstances). As of December 31, 2025, we invested $1.2 million in Tetragon. For
additional details regarding our contractual obligations, see Note 14 to our audited financial statements included in this Annual Report
on Form 20-F.
In addition, under our in-licensing agreements, we are obligated
to make certain payments to our licensors upon the achievement of agreed-upon milestones and receipt of royalties. We are unable at this
time to estimate the actual amount or timing of the costs we will incur in the future under these agreements. Some of the in-licensing
agreements are accompanied by consulting, support and cooperation agreements, pursuant to which we are required to pay the licensors a
fixed monthly amount, over a period stipulated in the applicable agreement, for their assistance in the continued research and development
under the applicable license. All of our in-licensing agreements are terminable at-will by us upon prior written notice of 30 to 90 days.
We are unable at this time to estimate the actual amount or timing of the costs we will incur in the future under these agreements. See
“Item 4. Information on the Company - Business Overview - In-Licensing Agreements.”
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C. Research and Development, Patents and Licenses
For our research and development policies, see “Item 4.B.
- Information on the Company - Business Overview - Our Strategy.” For information regarding patents, see “Item 4.B. - Information
on the Company -Business Overview - Intellectual Property.” For information regarding licenses, see “Item 4.B. - Information
on the Company - Business Overview - Collaboration and Out-Licensing Arrangements” and “Item 4.B. - Information on the Company
- Business Overview - In-Licensing Agreements.”
D. Trend Information
We are a biopharmaceutical company pursuing life-changing therapies
in oncology and rare diseases. To date, we have generated only limited direct product revenues from independent commercialization activities,
following the regulatory approval for APHEXDA (motixafortide) in September 2023. In October 2023, we out-licensed the rights to motixafortide
for all indications in substantially all of Asia, and in November 2024, we out-licensed the global rights (other than in Asia) to motixafortide
for all indications, other than solid tumors. As a result of the November 2024 transaction, we shut down our independent commercialization
activities in the United States and refocused our operations on development activities in Israel in the fields of oncology (including
solid tumors) and rare diseases, at a significantly reduced annual cash burn rate. Our ability to generate revenues from commercialization
and achieve profitability will be subject to Gloria License Agreement and the Ayrmid License Agreement and depend on our commercialization
partners’ ability to successfully commercialize products, including any of our current product and product candidates, and other
product candidates that we may develop, in-license or acquire in the future. As such, it is not possible for us to predict with any degree
of accuracy any known trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our
net sales or revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause reported
financial information to not necessarily be indicative of future operating results or financial conditions. However, to the extent possible,
certain trends, uncertainties, demands, commitments and events are in this “Operating and Financial Review and Prospects.”
E. Critical Accounting Estimates
Our consolidated financial statements are prepared in conformity
with IFRS, as issued by the IASB. In preparing our consolidated financial statements, we make judgements, estimates and assumptions about
the application of our accounting policies which affect the reported amounts of assets, liabilities, revenue and expenses. Our critical
accounting judgements and sources of estimation uncertainty are described in Note 2 to our consolidated financial statements, which are
included elsewhere in this Annual Report on Form 20-F.