The Deficiency Notices On May 6th, 2024, the Company announced that on April 30th it had had received a staff determination letter from the Listing Qualifications Department (the "Staff") of the Nasdaq Stock Market ("Nasdaq") notifying the Company that, due to the Company's non-compliance with the minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), the Company's American Depositary Shares ("ADSs") would be scheduled for delisting from Nasdaq and would be suspended for trading un ...

Financial Position - As of December 31, 2023, the company's cash and cash equivalents totaled $4.9 million, with an operating loss of $9.7 million for the twelve months ended December 31, 2023[46]. - The company reported negative cash flows from operating activities of $9.3 million, raising substantial doubt about its ability to continue as a going concern[46]. - The current cash position is insufficient to fund planned operations for at least one year beyond the filing date of the financial statements[46]. - The company had $4.9 million in cash and cash equivalents and short-term deposits, with working capital of $3.6 million, which is insufficient to fund projected cash requirements for at least the next 12 months[52]. - As of December 31, 2023, the company had an accumulated deficit of $122.5 million and expects to incur substantial losses for the foreseeable future[51]. Business Strategy and Operations - The company is implementing a cost-saving plan that includes reducing headcount costs and postponing/canceling non-essential capital expenditures[48]. - The company has suspended further development of its COVID-19 NanoAbs program due to changing market conditions and is seeking a partner for future development[34]. - The company is focusing on developing VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17) for conditions like psoriasis and psoriatic arthritis, having suspended further development of its COVID-19 NanoAb due to decreased market conditions[63]. - The company has licensed anti-COVID-19 NanoAbs and anti-IL-17 NanoAbs, with the latter targeting conditions like psoriasis[34]. - The company is reliant on entering agreements with partners for the development and commercialization of its product candidates[44]. Regulatory and Compliance Risks - The company faces significant challenges in developing and commercializing its product candidates due to regulatory uncertainties and market acceptance issues[66]. - Regulatory approval for current and future product candidates is expensive and time-consuming, with a high rate of attrition in clinical trials[71]. - The FDA or comparable authorities can delay or deny approval for various reasons, which could severely undermine the company's business[72]. - Ongoing regulatory requirements must be met even after obtaining approval, and failure to comply could result in loss of approvals and reduced revenues[74]. - The company must submit an Investigational New Drug application to the FDA before commencing clinical trials, which adds to the regulatory burden[83]. Competition and Market Challenges - The company faces significant competition in the biopharmaceutical sector, particularly in the development of NanoAbs[44]. - The company may face competition from biosimilar products sooner than anticipated, impacting the commercial prospects of its biological products[76]. - Intense competition from larger pharmaceutical companies could reduce the company's commercial opportunities and profitability[135]. - The company faces significant competition from well-established CDMO providers and small biotech firms, which may hinder its planned CDMO business[123]. Financial and Capital Requirements - The company may require additional financing to achieve its goals, and failure to obtain necessary capital could delay or terminate product development efforts[52]. - The company’s ability to execute its business plan is dependent on raising capital through various means, including private or public financings[53]. - The company’s future capital requirements are uncertain and may not be available on favorable terms, impacting its ability to acquire new product candidates and conduct necessary research[55]. - Recent financial market disruptions could affect the company's ability to raise capital on acceptable terms[146]. Intellectual Property Risks - The company faces risks related to the adequacy of its patent protection, which may not sufficiently shield against competitors with similar products and technologies[169]. - There is uncertainty regarding the issuance of patents from pending applications, and existing patents may be challenged or invalidated, impacting the company's competitive position[170]. - The company may incur significant costs and resource diversion due to litigation related to intellectual property rights, which could adversely affect its financial condition[180]. - The company may need to obtain licenses for third-party intellectual property, which could involve significant fees and may not be available on favorable terms[173]. Operational Risks - The company relies on third parties for clinical trials and manufacturing, which increases the risk of delays and impacts on product development[160]. - A disruption to the GMP biologics manufacturing facility in Jerusalem could impede the advancement of NanoAbs programs and CDMO services[164]. - The company may not obtain necessary materials for future clinical trials, which could delay regulatory approvals[167]. - The company has exclusive licenses for its NanoAbs program, and disputes with licensors could adversely affect operations[157]. Geopolitical and Environmental Risks - The company is subject to geopolitical risks that could adversely affect its operations and financial conditions[190]. - The ongoing conflict has led to Moody's downgrading Israel's credit rating from A1 to A2, which could impact the company's ability to raise capital on reasonable terms[200]. - Since October 7, 2023, the IDF has called up more than 350,000 reserve forces, which may affect the company's operations due to potential labor shortages[197]. Nasdaq Compliance and Corporate Governance - The company received a notice of non-compliance from Nasdaq on November 1, 2023, regarding the minimum bid price requirement of $1.00 per share, with a 180-day period to regain compliance[214]. - As of December 31, 2023, the company's shareholders' equity was less than the required minimum of $2,500,000 for continued listing on Nasdaq, posing a risk of delisting[215]. - The company has appealed the delisting determination and requested a hearing, which has temporarily stayed any suspension of trading[214]. - The company follows home country corporate governance practices, which may provide less protection to investors compared to U.S. domestic issuers[221].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-37353 BIONDVAX PHARMACEUTICALS LTD. (Exact name of registrant as specified in its charter) | Israel | Not Applic ...

Financial Performance - For the year ended December 31, 2022, the net loss was $5.8 million, a decrease from the net loss of $8.2 million for the year ended December 31, 2021, reflecting improved financial performance [313]. - The accumulated deficit amounted to $115.8 million as of December 31, 2022, indicating ongoing financial challenges [318]. - The company expects to continue incurring operating losses and may need to raise additional funds to support its research and development activities [303]. Research and Development - Research and development expenses increased to $5.7 million for the year ended December 31, 2022, compared to $3.2 million for the year ended December 31, 2021, primarily due to increased salaries and expenses related to the COVID-19 NanoAb project [304]. - The company signed a five-year Research Collaboration Agreement with MPG and UMG for the discovery and development of NanoAbs for various diseases, which are expected to address large and growing markets [300]. - The company anticipates that a significant portion of future research and development expenses will be related to its clinical development projects, which are inherently unpredictable [305]. Cash and Funding - As of December 31, 2022, the company had cash and cash equivalents of $14 million, down from $17.3 million as of December 31, 2021 [314]. - The company raised gross proceeds of approximately $8 million from a public follow-on offering completed in December 2022 [308]. - The Company closed an underwritten offering selling 1,600,000 units, receiving a net sum of $7.3 million after issuance expenses [321]. - Each unit was sold at a combined purchase price of $5.00, with pre-funded units priced at $4.999 [321]. - The company has received $5.8 million in IIA grants and €24 million ($25.6 million) in EIB loans since its inception, which have supported its operations [311]. Clinical Trials - The company has executed eight clinical trials, including a phase 3 trial with 12,400 participants for its previous lead drug candidate, M-001, which is no longer under development [297]. Asset Valuation - No impairment indicators for long-lived assets were identified during the years ended December 31, 2022 and 2021 [324]. - The fair value of financial instruments is measured based on a three-tiered hierarchy prioritizing inputs used in valuation methodologies [325]. - The Company is not required to provide market risk disclosures as it qualifies as a smaller reporting company [326].

Financial Data and Key Metrics Changes - As of the end of 2021, the company held $17.4 million in cash, which is expected to be sufficient to reach the first in-human studies for the COVID-19 NanoAbs [12][37] - The company has agreed on terms for restructuring its outstanding debt to the European Investment Bank, extending the maturity date to December 31, 2027, which will provide a runway for development [10][11] Business Line Data and Key Metrics Changes - The company is progressing with the COVID-19 NanoAb development, focusing on technology transfer and scale-up of the manufacturing process [5][6] - A recent collaboration with the Max Planck Institute and University Medical Center Göttingen will expand the NanoAb platform to include nine additional NanoAbs targeting diseases with unmet medical needs [8][9] Market Data and Key Metrics Changes - The market for COVID-19 treatments is expected to grow, with estimates indicating it has already surpassed $2 billion [33] - The company is targeting therapeutic areas such as asthma, psoriasis, psoriatic arthritis, and macular degeneration, which have a compound annual growth rate (CAGR) of 8% to 12% [31][33] Company Strategy and Development Direction - The company aims to develop a self-administered inhaled COVID-19 NanoAb that is expected to have a lower adverse events profile and be more affordable than current therapies [30][31] - The strategy includes a focus on well-validated targets for existing monoclonal antibody treatments to reduce risk [43] Management's Comments on Operating Environment and Future Outlook - Management believes that COVID-19 will continue to circulate, necessitating a range of therapeutic options alongside vaccines [28][29] - The company anticipates initiating clinical trials for the COVID-19 NanoAb in 2023, with potential market entry depending on the pandemic situation [35][51] Other Important Information - The company has strengthened its R&D capabilities by hiring top talent and enhancing its Board with experienced individuals from the pharmaceutical industry [13][15] - The manufacturing site is designed to meet FDA and EMA standards, allowing for rapid drug development and lower risk of delays [36] Q&A Session Summary Question: What are the advantages of NanoAbs over similar therapies in general? - NanoAbs can be developed to be more potent and stable, allowing for lower concentrations and potentially fewer side effects [39][40] Question: What are the risks of using NanoAbs? - Risks include the potential for immune responses and on-target risks, but NanoAbs may be less immunogenic due to their compact structure [41][42] Question: What do you estimate will be the retail cost per unit of the COVID treatment relative to other COVID therapies? - The company expects to price its treatment substantially lower than existing therapies, which can cost around $2,000 per dose [44][45] Question: What are the upcoming catalysts? - Key catalysts include finalizing the agreement with the EIB and conducting proof-of-concept studies for the inhalation route of administration [46][47] Question: When do you expect the first COVID-19 drug to be in the market? - The company anticipates a worst-case scenario of filing for marketing approval by 2026, depending on the pandemic situation [51][52] Question: Are there any other companies developing NanoAbs? - Other companies exist, such as Ablynx, but the company believes its capabilities and partnerships provide a competitive edge [53][54] Question: How does the company plan to address COVID mutations? - The company plans to develop NanoAbs that can neutralize all variants of concern, adapting its approach similar to influenza vaccine strategies [56][57]

Financial Position - The company has incurred an accumulated deficit of $117.3 million as of December 31, 2021, and expects to experience negative cash flow for the foreseeable future [40]. - The company had approximately $17.4 million in cash and cash equivalents and working capital of $15.4 million as of December 31, 2021, which is expected to fund operations for at least the next 12 months [41]. - The company may require substantial additional financing to achieve its goals, and failure to obtain necessary capital could delay or terminate product development efforts [41]. - The company may seek additional capital through private and public equity offerings, debt financings, and strategic partnerships, which could lead to dilution of existing shareholders [53]. - The company’s balance sheet is expected to primarily consist of cash and cash equivalents, impacting its PFIC status based on asset composition [197]. Product Development and Pipeline - The company does not currently have any product candidates that generate revenue and does not expect to become profitable in the near future [38]. - The company’s business strategy is evolving from being a one-product company focused on M-001 to building a diversified pipeline of assets [45]. - The company has a pipeline of products aimed at preventing and treating infectious diseases, with various routes of drug delivery and at different stages of clinical development [50]. - The company has entered into a licensing and collaboration arrangement for its Covid-19 NanoAbs program, although it currently has no product candidates in clinical trials or on the market [54]. - The company’s NanoAbs program is at an earlier stage of clinical development compared to M-001, and its success is uncertain [45]. Regulatory and Compliance Challenges - Regulatory approval processes for current and future product candidates are extensive and can take many years, with no guarantee of success [63]. - Ongoing regulatory requirements will apply even after obtaining approval for product candidates, and failure to comply could result in loss of approvals [66]. - The company faces significant regulatory challenges that could hinder the approval and commercialization of current and future product candidates, potentially impacting financial performance [104]. - The FDA may not accept data from clinical trials conducted outside the U.S., potentially requiring additional costly trials [77]. - The company is subject to extensive government regulations that increase the cost and risk associated with research, development, and sales of pharmaceutical products [105]. Market and Competitive Landscape - The company faces significant competition in the biopharmaceutical market, which may impact its marketing and sales efforts [39]. - Current and future product candidates may encounter competition sooner than expected, particularly from biosimilar products, impacting market exclusivity [68]. - The twelve-year exclusivity period for biological products may not be granted or could be shortened, leading to earlier generic competition [69]. - The company operates in a highly competitive environment, facing challenges from larger pharmaceutical firms with greater resources and experience [117]. Risks and Liabilities - The company may face product liability lawsuits, which could result in substantial financial liabilities and affect commercialization efforts [123]. - Serious side effects reported during clinical trials could lead to regulatory refusal of product approvals or revocation of existing authorizations [86]. - The company is exposed to risks associated with insider trading allegations, which could negatively impact its reputation and stock price [127]. - Employee misconduct or fraud could lead to significant regulatory sanctions and reputational harm, impacting business operations [126]. - The company may struggle with market acceptance and sales of product candidates if coverage and reimbursement policies are not favorable, which could affect profitability [95]. Intellectual Property Concerns - The company faces significant risks related to intellectual property, including potential challenges to patent rights that could limit competitive advantage [157]. - The ability to enforce patent rights may be hampered by financial resources, leading to potential loss of exclusivity and market position [165]. - Litigation related to intellectual property claims could result in substantial costs and divert management's attention from core business activities [169]. - The company may need to initiate costly litigation to protect its intellectual property rights, which could strain resources and impact financial stability [164]. Operational and Strategic Considerations - The company must establish and maintain strategic collaborations to successfully commercialize its pipeline candidates, as its long-term viability depends on these partnerships [59]. - The company relies on third parties for clinical trials and product development, which may lead to delays if these parties do not perform satisfactorily [145]. - The company must attract and retain qualified personnel to effectively operate its business, which may be challenging due to limited financial resources [113]. - The company may face difficulties in managing growth, which could adversely affect its business and financial condition [128]. Economic and Market Conditions - Future economic conditions, influenced by the COVID-19 pandemic, may disrupt global financial markets and affect the company's liquidity and financial position [91]. - The ongoing COVID-19 pandemic has created uncertainty regarding the company's ability to identify and develop product candidates, which may adversely affect future revenues [90]. - The market price for the ADSs has been and is likely to remain highly volatile, influenced by factors such as clinical trial authorizations and regulatory approvals [209]. - The trading prices for securities of other biopharmaceutical companies have been highly volatile, particularly due to the COVID-19 pandemic [212]. Corporate Governance and Shareholder Issues - Angels Investments in High Tech Ltd. holds approximately 22.7% of the voting power of the outstanding ADSs, allowing it to significantly influence corporate actions [195]. - The company has not paid any cash dividends on the ADSs since inception and does not anticipate paying any in the foreseeable future [203]. - Holders of ADSs do not have the same rights as ordinary shareholders and may face limitations in exercising voting rights [206]. - The company’s articles of association stagger the election of directors, which may hinder a potential acquirer from easily changing the board [189].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 001-3735 ...