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GeoVax Labs(GOVX) - 2021 Q4 - Annual Report
2022-03-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the fiscal year ended December 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 001-39563 GEOVAX LABS, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of 87-0455038 (IRS Employer Identification Number) 1900 Lake Park ...
GeoVax Labs(GOVX) - 2021 Q3 - Earnings Call Transcript
2021-11-12 03:49
Financial Data and Key Metrics Changes - Cash balances at September 30 were $18 million compared to just under $10 million at December 31 of the previous year [25] - Working capital increased to $17.8 million from $9.4 million [25] - Net loss for the nine-month period of 2021 was $4.8 million or $0.80 per share, compared to a net loss of $1.6 million or $2.85 per share in the prior year [28] Business Line Data and Key Metrics Changes - Grant and collaboration revenues were $220,000 in 2021 compared to $1.6 million in 2020, with 2021 revenues relating entirely to a grant from the NIH for the COVID-19 vaccine [26] - Research and development expenses rose to $2.7 million in 2021 from $1.7 million in 2020, attributed to license fees and increased activity related to COVID-19 vaccine programs [27] Market Data and Key Metrics Changes - The company has confirmed two additional clinical sites for the Gedeptin trial and initiated the IND transfer [9] - The Phase 2 clinical trial for the COH04S1 vaccine is the only one prospectively studying safety and effectiveness in blood cancer patients who have received bone marrow transplants or CAR-T therapy [12] Company Strategy and Development Direction - The company remains focused on delivering results in COVID-19 and immuno-oncology, aiming to secure resources for growth and development [6] - The exclusive license for the COH04S1 vaccine is expected to significantly accelerate development activities in the COVID-19 prevention market [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress and outlook for the company, highlighting successful entry into clinical development for both immuno-oncology and COVID-19 vaccine programs [7][8] - The company anticipates that existing cash reserves are sufficient to advance programs through mid-2022 [30] Other Important Information - The company is developing a portfolio of hemorrhagic fever virus vaccines with support from the federal government [10] - The Gedeptin program is being evaluated for potential expansion into first-line treatment options [45] Q&A Session Summary Question: Is there data showing mRNA vaccines are insufficient for immunocompromised patients? - Yes, existing data indicates that mRNA vaccines function sub-optimally in immunocompromised patients, which is why the focus is on this population [38] Question: What type of patient needs will be enrolled in the booster study? - The study will focus on healthcare workers who are healthy volunteers and have received the Pfizer vaccine [41] Question: What is the timeline for data readout from the Gedeptin program? - Currently, the company is in the process of transferring IND and expanding clinical sites, making it difficult to project a data readout timeline [43] Question: Will the clinical development of the 04S1 vaccine expand to other immunocompromised groups? - Yes, there is interest in expanding to other immunocompromised populations, but it will be data-driven based on initial results [50] Question: What is the status of pre-clinical studies for Marburg and Sudan viruses? - Ongoing tests are being conducted, and the decision to move into clinical trials will depend on market forces and federal funding priorities [53]
GeoVax Labs(GOVX) - 2021 Q3 - Quarterly Report
2021-11-11 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q 1900 Lake Park Drive, Suite 380 Smyrna, Georgia 30080 (Address of principal executive of ices) (Zip Code (State or other jurisdiction (IRS Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ...
GeoVax Labs(GOVX) - 2021 Q2 - Earnings Call Transcript
2021-08-12 02:53
GeoVax Labs, Inc. (NASDAQ:GOVX) Q2 2021 Earnings Conference Call August 11, 2021 4:30 PM ET Company Participants Jules Abraham - CORE, Investor Relations David Dodd - Chairman and Chief Executive Officer Mark Newman - Chief Scientific Officer Mark Reynolds - Chief Financial Officer Conference Call Participants Jason McCarthy - Maxim Group Jeffrey Kraws - Crystal Research Operator Good day and welcome to the GeoVax Second Quarter 2021 Corporate Update Call. I am [Gran], with Chorus Call and will facilitate ...
GeoVax Labs(GOVX) - 2021 Q2 - Quarterly Report
2021-08-10 16:00
Financial Performance - Grant and collaboration revenue for Q2 2021 was $79,708, a decrease of 82% from $440,602 in Q2 2020[52] - Total operating expenses for Q2 2021 were $1,566,334, an increase of 76% from $888,713 in Q2 2020[52] - Net loss for Q2 2021 was $1,314,033, compared to a net loss of $455,204 in Q2 2020, representing an increase of 188%[52] - The company has accumulated net losses of approximately $48.7 million since inception through June 30, 2021[66] Research and Development - Research and development expenses increased by $371,414 (80%) in Q2 2021 compared to Q2 2020, primarily due to COVID-19 vaccine program expenditures[56] - The most advanced vaccine program is focused on HIV prevention, expected to enter an upcoming clinical trial (HVTN 132)[49] - The company anticipates an increase in research and development costs as it progresses towards later stages of development, particularly for clinical trials[74] - General and administrative expenses are expected to remain consistent for the remainder of 2021 but will increase beyond 2021 to support expanded research and development activities[75] - NIAID has funded all human clinical trials to date for the company's preventive HIV vaccines, with further funding expected for planned trials[77] Cash Flow and Financing - Cash and cash equivalents increased to $19,538,513 as of June 30, 2021, compared to $9,883,796 as of December 31, 2020, representing a 97.5% increase[67] - Net cash used in operating activities was $2,879,566 for the six months ended June 30, 2021, compared to $925,493 for the same period in 2020, indicating a significant increase in operational losses[67] - Net cash provided by financing activities was $12,554,212 for the six months ended June 30, 2021, primarily from a public offering of common stock, which generated net proceeds of $9,408,920[69] - The company expects existing cash resources to be sufficient to meet anticipated cash requirements through mid-2023, although this is subject to risks and uncertainties[71] - The company may need to raise additional capital to support future operating activities, including development programs and commercialization efforts[73] Government Support and Partnerships - Ongoing government support includes a Small Business Innovative Research (SBIR) grant for the COVID-19 vaccine program[49] - The company plans to pursue partnerships or licensing arrangements to achieve regulatory approval and commercialization of its products[50] - The company has $275,302 in approved grant funds for its COVID-19 vaccine program, expected to be expended during the remainder of 2021 and early 2022[76] - As of June 30, 2021, there are 2,793,635 stock purchase warrants outstanding, which could generate approximately $9.3 million in gross proceeds if fully exercised[78]
GeoVax Labs(GOVX) - 2021 Q1 - Earnings Call Transcript
2021-05-09 14:16
Financial Data and Key Metrics Changes - Cash balances increased to $20.8 million as of March 31, 2021, compared to $9.9 million at December 31, 2020, primarily due to a February overnight offering that raised net proceeds of $9.4 million [35] - Working capital rose to $20.5 million from $9.4 million at the end of 2020 [35] - Net loss for Q1 2021 was $1.6 million or $0.29 per share, compared to a net loss of $596,000 or $2.54 per share in Q1 2020 [39] Business Line Data and Key Metrics Changes - Grant and collaboration revenues decreased to $110,000 in Q1 2021 from $716,000 in Q1 2020, primarily due to a shift in activities to external subcontractors for manufacturing work [37] - R&D expenses were $603,000 in Q1 2021, down from $809,000 in Q1 2020, reflecting the timing of grant expenditures [38] - General administrative expenses increased to over $1 million in Q1 2021 from $502,000 in Q1 2020, largely due to an increase in Delaware franchise tax and other administrative costs [38] Market Data and Key Metrics Changes - The company is focused on developing a universal coronavirus vaccine to provide broad and durable protection against emerging variants of SARS-CoV-2 [10][11] - The company is also advancing initiatives in immuno-oncology, with encouraging results from animal testing [16] Company Strategy and Development Direction - The company aims to provide a single-dose, safe, and durable universal coronavirus vaccine, leveraging technology that requires minimal refrigeration [10] - The focus remains on advancing the COVID-19 vaccine program and immuno-oncology developments while progressing other vaccine programs with minimal resource distraction [17] - The company is strengthening its intellectual property portfolio, with over 70 granted or pending patent applications [15] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing threat of emerging SARS-CoV-2 variants and the need for vaccines that can adapt to these changes [7][8] - The company anticipates further strengthening its balance sheet and is well-capitalized to advance priority programs into clinical development over the next 12 to 15 months [14] - Management expressed confidence in the potential for government funding to support clinical development of vaccines for hemorrhagic fevers, given the high fatality rates associated with these viruses [55][56] Other Important Information - The company has successfully raised over $10 million and added over $3 million from warrant exercises, resulting in a cash position of over $20 million [13] - The company is in discussions with federal government authorities regarding stockpile programs for vaccines targeting hemorrhagic fevers [56] Q&A Session Summary Question: Can you discuss the differences between mRNA vaccines and MVA-based vaccines regarding T-Cell immunity? - Management explained that MVA vaccines are designed to induce broader T-Cell memory responses, potentially providing long-term immunity with a single dose, unlike mRNA vaccines that may require multiple doses to address variants [48][50] Question: What is the status of the hemorrhagic fever virus programs? - Management acknowledged the government's interest in stockpiling vaccines for hemorrhagic fevers and indicated ongoing discussions regarding funding for clinical development based on positive animal testing results [55][56] Question: What are the company's thoughts on the Biden administration's discussions about waiving patent protections for COVID vaccines? - Management expressed concerns that waiving patent protections could inhibit innovation and emphasized the importance of allowing markets to operate effectively [59] Question: When is the MUC1 antigen program expected to move into the clinic? - Management indicated that the start of the trial will depend on the manufacturing schedule, with expectations to begin around mid to late next year [62] Question: How does the company plan to address the manufacturing challenges associated with MVA? - Management is actively evaluating continuous cell lines for MVA production and is in the process of selecting a contract development manufacturing operation to ensure scalability for future vaccine needs [88][89]
GeoVax Labs(GOVX) - 2021 Q1 - Quarterly Report
2021-05-05 16:00
PART I – FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Unaudited statements show a wider net loss despite increased assets from financing activities - The company is considered a **going concern**, with management believing cash is sufficient for operations into 2023[28](index=28&type=chunk) - The company enacted **two reverse stock splits** in 2020, and all share data has been retroactively restated[27](index=27&type=chunk) [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets doubled to $21.1 million and stockholders' equity grew to $20.7 million, driven by financing activities Condensed Consolidated Balance Sheet Highlights (as of March 31, 2021 vs. December 31, 2020) | Balance Sheet Item | March 31, 2021 (unaudited) | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $20,842,782 | $9,883,796 | | Total current assets | $20,961,212 | $10,235,148 | | Total assets | $21,115,446 | $10,393,899 | | **Liabilities & Equity** | | | | Total current liabilities | $451,949 | $810,309 | | Total liabilities | $464,106 | $825,047 | | Total stockholders' equity | $20,651,340 | $9,568,852 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's Q1 net loss widened to $1.6 million from $0.6 million year-over-year due to lower revenue and higher G&A costs Condensed Consolidated Statements of Operations (Three Months Ended March 31) | Operating Metric | 2021 | 2020 | | :--- | :--- | :--- | | Grant and collaboration revenues | $110,417 | $715,977 | | Research and development expense | $602,783 | $808,936 | | General and administrative expense | $1,071,710 | $502,345 | | Loss from operations | ($1,564,076) | ($595,304) | | Net loss | ($1,562,778) | ($595,694) | | Net loss per common share | ($0.29) | ($2.54) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash increased by $11.0 million, as $12.6 million from financing activities offset a $1.6 million operating cash outflow Cash Flow Summary (Three Months Ended March 31) | Cash Flow Activity | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,621,027) | ($358,620) | | Net cash provided by financing activities | $12,580,013 | $297,086 | | Net increase (decrease) in cash | $10,958,986 | ($61,534) | | Cash and cash equivalents at end of period | $20,842,782 | $221,807 | - Financing activities in Q1 2021 included **$9.4 million** in net proceeds from a common stock sale and **$3.2 million** from warrant exercises[18](index=18&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's biotech business, a $9.4 million public offering, and a significant grant revenue decline - GeoVax is a clinical-stage biotech company developing immunotherapies and vaccines using its novel GV-MVA-VLP™ vector vaccine platform[20](index=20&type=chunk)[21](index=21&type=chunk) - A February 2021 public offering raised net proceeds of approximately **$9.4 million**[38](index=38&type=chunk) - The exercise of stock purchase warrants in Q1 2021 generated net proceeds of **$3,174,156**[40](index=40&type=chunk) - The company had approximately **$800,000** of unrecorded purchase commitments as of March 31, 2021, expected to be due in 2021[37](index=37&type=chunk) Grant and Collaboration Revenue (Q1 2021 vs Q1 2020) | Description | Revenues Recorded Q1 2021 | Revenues Recorded Q1 2020 | Approved Funds Available at Mar 31, 2021 | | :--- | :--- | :--- | :--- | | Lassa Fever – U.S. Army Grant | $ - | $654,021 | $165,500 | | Covid-19 – NIH SBIR Grant | $110,417 | $ - | $189,510 | | Malaria – Leidos, Inc. Collaboration | $ - | $61,956 | $ - | | **Total** | **$110,417** | **$715,977** | **$355,010** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=10&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses improved liquidity from financing, a wider net loss, and its vaccine development strategy [Overview](index=10&type=section&id=Overview) The company is a clinical-stage biotech developing vaccines and immunotherapies, seeking partnerships for commercialization - Development programs target **COVID-19, HIV, hemorrhagic fever viruses (Ebola, Lassa), Zika, and malaria**, as well as immunotherapies for solid tumor cancers[47](index=47&type=chunk) - The most advanced program, HIV vaccine **GOVX-B11**, is slated for the HVTN 132 clinical trial, expected to begin in late 2021[50](index=50&type=chunk) - The corporate strategy involves advancing products through human clinical testing before seeking **partnership or licensing arrangements**[51](index=51&type=chunk) [Liquidity and Capital Resources](index=12&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity improved with cash at $20.8 million, deemed sufficient to fund operations into 2023 despite ongoing losses Key Liquidity Metrics (as of March 31, 2021 vs. December 31, 2020) | Metric | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $20,842,782 | $9,883,796 | | Working capital | $20,509,263 | $9,424,839 | - Net cash from financing activities in Q1 2021 was **$12,580,013**, primarily from a **$9,408,920** public offering and **$3,174,156** in warrant exercises[59](index=59&type=chunk)[60](index=60&type=chunk) - Management believes existing cash resources will fund planned operations into 2023, but **additional funds will be required** beyond that date[63](index=63&type=chunk) [Results of Operations](index=14&type=section&id=Results%20of%20Operations) Q1 net loss increased to $1.6 million as lower grant revenue and higher G&A costs offset a 25% drop in R&D spending Comparison of Operating Results (Three Months Ended March 31) | Item | 2021 | 2020 | | :--- | :--- | :--- | | Net Loss | $1,562,778 | $595,694 | | Grant and Collaboration Revenues | $110,417 | $715,977 | | Research and Development Expenses | $602,783 | $808,936 | | General and Administrative Expenses | $1,071,710 | $502,345 | - The **decrease in R&D expenses by 25%** was primarily due to the timing of external expenditures related to government grants[70](index=70&type=chunk) - The **105% increase in G&A expenses** (excluding stock compensation) was due to higher Delaware franchise taxes, legal, patent, and personnel costs[73](index=73&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=15&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Market risk is limited to interest rate sensitivity on cash investments, with no derivative or foreign currency exposure - Market risk is limited mainly to **interest income sensitivity** from changes in U.S. interest rates on institutional money market funds[77](index=77&type=chunk) - The company **does not use any derivative financial instruments** or foreign currency instruments[77](index=77&type=chunk) [Item 4. Controls and Procedures](index=16&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2021 - Based on an evaluation, the CEO and CFO concluded that the company's **disclosure controls and procedures are effective**[79](index=79&type=chunk) - There were **no significant changes in internal control** over financial reporting during Q1 2021 that have materially affected, or are reasonably likely to materially affect, internal controls[80](index=80&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=16&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings - None[83](index=83&type=chunk) [Item 1A. Risk Factors](index=16&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the most recent Form 10-K are reported - There have been **no material changes** from the risk factors previously disclosed in the company's most recent Annual Report on Form 10-K[84](index=84&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=16&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued 1,472 unregistered shares valued at $6,000 for social media services in Q1 2021 - In Q1 2021, the company issued **1,472 shares of common stock valued at $6,000** for services, relying on a registration exemption[85](index=85&type=chunk) [Item 3. Defaults Upon Senior Securities](index=16&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[86](index=86&type=chunk) [Item 4. Mine Safety Disclosures](index=17&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[87](index=87&type=chunk) [Item 5. Other Information](index=17&type=section&id=Item%205.%20Other%20Information) No required Form 8-K disclosures were omitted during the quarter - No information required to be disclosed in a Form 8-K was omitted during the period[87](index=87&type=chunk) [Item 6. Exhibits](index=17&type=section&id=Item%206.%20Exhibits) The report lists key exhibits including agreements, certifications, and XBRL data files - Exhibits filed include the Underwriting Agreement, Form of Underwriter's Warrant Agreement, Certifications, and XBRL documents[88](index=88&type=chunk)
GeoVax Labs(GOVX) - 2020 Q4 - Earnings Call Transcript
2021-03-24 15:41
Financial Data and Key Metrics Changes - Cash balances at the end of 2020 were $9.9 million, a significant increase from $283,000 in 2019, indicating a dramatic improvement in financial position [30] - Working capital improved to $9.4 million from a negative $1.6 million at the end of 2019 [30] - Net loss for 2020 was $3 million, or $2.14 per share, compared to a loss of $2.4 million, or $781 per share in 2019 [38] Business Line Data and Key Metrics Changes - Grant and collaboration revenues increased to $1.8 million in 2020 from $1.2 million in 2019, with $1.4 million related to a U.S. Army grant for the Lassa Fever vaccine program [34] - R&D expenses rose to $2.4 million in 2020 from $1.9 million in 2019, reflecting increased spending on grant-funded programs [36] - G&A expenses increased to $2.2 million from $1.6 million, attributed to costs associated with NIH licenses and investor relations [36] Market Data and Key Metrics Changes - The company raised over $10 million gross from a public offering, resulting in a total cash position exceeding $20 million with no debt [13][33] - The company has over 70 granted or pending patent applications, enhancing its competitive position in the market [14] Company Strategy and Development Direction - The company is focused on advancing its COVID-19 vaccine program and immuno-oncology developments, with a commitment to developing a universal coronavirus vaccine [15][12] - A license agreement with NIH provides full access to critical patents for COVID-19 vaccine development, underscoring the company's confidence in its unique approach [8] - The company aims to develop vaccines that induce immune responses not significantly impacted by variants, moving towards a universal vaccine rather than annual reconfigured vaccines [11][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position and ability to advance priority programs into clinical development over the next 12 to 15 months [13][40] - The company anticipates updates regarding near-term data milestones and continued progress in its development programs [56] Other Important Information - The company has successfully raised additional funds through various offerings, including a February 2021 offering that raised $9.4 million [32] - The capital structure is clean, with no toxic conversion features associated with prior capital structures, positioning the company well for future growth [42] Q&A Session Summary Question: Can you elaborate on the immune response generated by MVA and VLPs? - Management explained that targeting core elements of coronaviruses is crucial for generating T cell and B cell responses, which are essential for long-term immunity [47][48] Question: What is the timing for moving into a Phase 1 study? - The company expects to initiate a Phase 1 trial for the universal coronavirus vaccine in Q2 or Q3 of the following year, pending animal data and candidate selection [53]
GeoVax Labs(GOVX) - 2020 Q4 - Annual Report
2021-03-22 16:00
[Part I](index=4&type=section&id=PART%20I) [Business](index=4&type=section&id=ITEM%201.%20BUSINESS) GeoVax develops vaccines and immunotherapies for infectious diseases and cancers using its GV-MVA-VLP™ platform, relying on collaborations and third-party manufacturing - GeoVax is a clinical-stage biotechnology company focused on developing immunotherapies and vaccines for cancers and infectious diseases, including COVID-19, using its novel GV-MVA-VLP™ vector vaccine platform[13](index=13&type=chunk) - The company's corporate strategy is to advance its vaccine platform through development, protection, and exploitation, aiming for regulatory registration and commercialization while considering collaborations to maximize stockholder value[18](index=18&type=chunk) - GeoVax relies on third-party contract manufacturers for all clinical and commercial supplies and notes a current shortage of vaccine manufacturing capability due to the high demand for COVID-19 vaccines[98](index=98&type=chunk)[99](index=99&type=chunk) Research and Development Expenses (2019-2020) | Year | R&D Expense | | :--- | :--- | | 2020 | $2,444,459 | | 2019 | $1,910,715 | [Product Development Pipeline](index=7&type=section&id=Product%20Development%20Pipeline) GeoVax's pipeline includes a Phase 2a completed preventive HIV vaccine and preclinical candidates for COVID-19, hemorrhagic fevers, Zika, malaria, and cancer immunotherapies Product Development Pipeline Status | Product Area / Indication | Stage of Development | | :--- | :--- | | **Cancer** | | | HPV-related cancers | Preclinical | | MUC1-expressing tumors | Preclinical completed | | **Infectious Diseases** | | | HIV (preventive) | Phase 2a completed | | HIV (immunotherapy) | Phase 1 | | Zika | Preclinical completed | | Malaria | Preclinical | | Ebola, Marburg, Sudan | Preclinical completed | | Lassa Fever | Preclinical | | Coronavirus (COVID-19) | Preclinical | - The company's most advanced program, the preventive HIV vaccine GOVX-B11, is set for an upcoming HVTN 132 clinical trial expected to begin in late 2021[16](index=16&type=chunk)[52](index=52&type=chunk) - In January 2020, GeoVax initiated a COVID-19 vaccine program, resulting in four candidates that are currently in preclinical animal testing with support from a NIAID SBIR grant[13](index=13&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk) - Preclinical studies for the Ebola (EBOV) vaccine candidate showed **100% protection** against a lethal dose with a single immunization in nonhuman primates. Similarly, the Marburg (MARV) and Sudan vaccine candidates showed **100% protection** in guinea pig challenge studies[61](index=61&type=chunk)[62](index=62&type=chunk) [Support from the United States Government](index=16&type=section&id=Support%20from%20the%20United%20States%20Government) GeoVax receives significant U.S. government funding, including DoD and NIAID grants, for its Lassa Fever, COVID-19, malaria, and HIV vaccine programs - In September 2018, the U.S. Department of Defense (DoD) awarded a **$2,442,307 cooperative agreement** to support the Lassa Fever (LASV) vaccine development program[78](index=78&type=chunk) - In January 2021, NIAID awarded a **$299,927 Phase I SBIR grant** to support the preclinical development of the company's COVID-19 vaccine candidates[79](index=79&type=chunk) - All human clinical trials for the preventive HIV vaccine to date have been conducted by the HVTN and fully funded by NIAID, a form of financial support not recognized in GeoVax's financial statements[84](index=84&type=chunk) [Intellectual Property](index=19&type=section&id=Intellectual%20Property) GeoVax's IP strategy includes 14 granted U.S. and 43 foreign patents as of December 31, 2020, with key technologies licensed from Emory University and NIH - As of December 31, 2020, GeoVax's patent estate includes **14 granted U.S. patents**, 16 pending U.S. applications, **43 granted foreign patents**, and 13 pending foreign applications[111](index=111&type=chunk) - The company holds an exclusive worldwide license from Emory University for key HIV vaccine technology, with related patents expiring between **2022 and 2028**[112](index=112&type=chunk)[119](index=119&type=chunk) - GeoVax has a non-exclusive commercial license from the NIH for the MVA backbone used in its SARS-CoV-2 vaccine and a research license for its other candidates[120](index=120&type=chunk) [Risk Factors](index=24&type=section&id=ITEM%201A.%20RISK%20FACTORS) GeoVax faces substantial risks from operating losses, funding needs, unproven products, regulatory uncertainty, reliance on third parties, competition, IP, and stock dilution - The company has a history of operating losses, incurring a net loss of **$2,958,068 in 2020**, and expects losses to continue for the foreseeable future[137](index=137&type=chunk) - GeoVax requires substantial additional financing for its operations. Current working capital is expected to be sufficient to support operations into **2023**, but additional funds will be needed beyond that[138](index=138&type=chunk)[141](index=141&type=chunk) - The company's products are still in development, unproven in human clinical trials, and have not been approved for sale by any government agency[147](index=147&type=chunk) - GeoVax relies heavily on the HIV Vaccine Trials Network (HVTN) and NIAID for the execution and funding of its HIV clinical trials, and does not control many aspects of their activities[139](index=139&type=chunk)[154](index=154&type=chunk) - There are **2,994,969 shares** issuable upon the exercise of outstanding warrants, which would cause significant dilution to existing shareholders[178](index=178&type=chunk) [Properties](index=24&type=section&id=ITEM%202.%20PROPERTIES) GeoVax leases 8,400 square feet of office and lab space in Smyrna, Georgia, under a lease expiring December 31, 2022 - The company leases **8,400 square feet** of office and laboratory space in Smyrna, Georgia, with the lease expiring on **December 31, 2022**[130](index=130&type=chunk) [Legal Proceedings](index=27&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) GeoVax is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[191](index=191&type=chunk) [Part II](index=33&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=33&type=section&id=ITEM%205%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) GeoVax common stock trades on Nasdaq under "GOVX"; the company has never paid dividends and does not anticipate doing so - The company's common stock is traded on The Nasdaq Capital Market under the symbol **"GOVX"**[194](index=194&type=chunk) - GeoVax has never declared or paid cash dividends on its common stock and does not plan to in the foreseeable future, intending to retain any future earnings for business operations[196](index=196&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) GeoVax's 2020 net loss increased to $2.96 million, but liquidity significantly improved to $9.88 million cash and $9.42 million working capital, sufficient into 2023 Financial Position Comparison (2019 vs 2020) | Metric | Dec 31, 2020 ($) | Dec 31, 2019 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $9,883,796 | $283,341 | | Working Capital | $9,424,839 | ($1,568,929) | - Net cash provided by financing activities was **$12.5 million in 2020**, largely from a public offering in September 2020 that yielded net proceeds of approximately **$11.2 million**[221](index=221&type=chunk)[226](index=226&type=chunk) - The company believes its existing cash resources, combined with current government grants, will be sufficient to fund planned operations into **2023**[231](index=231&type=chunk) Results of Operations (2019 vs 2020) | Line Item | 2020 ($) | 2019 ($) | | :--- | :--- | :--- | | Grant and Collaboration Revenues | $1,823,658 | $1,175,896 | | Research and Development Expenses | $2,444,459 | $1,910,715 | | General and Administrative Expenses | $2,196,014 | $1,637,674 | | Net Loss | ($2,958,068) | ($2,370,629) | [Controls and Procedures](index=40&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) As of December 31, 2020, management concluded that disclosure controls and internal control over financial reporting were effective - Management concluded that as of **December 31, 2020**, the company's disclosure controls and procedures were effective[252](index=252&type=chunk) - Management's assessment concluded that the company's internal control over financial reporting was effective as of **December 31, 2020**[253](index=253&type=chunk) [Part III](index=41&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=41&type=section&id=ITEM%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2021 proxy statement - The required information for this item is incorporated by reference from the company's **2021 annual meeting proxy statement**[258](index=258&type=chunk) [Executive Compensation](index=43&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Executive compensation information is incorporated by reference from the 2021 annual meeting proxy statement - The required information for this item is incorporated by reference from the company's **2021 annual meeting proxy statement**[262](index=262&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=43&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Security ownership and equity compensation plan information is incorporated by reference from the 2021 annual meeting proxy statement - The required information for this item is incorporated by reference from the company's **2021 annual meeting proxy statement**[263](index=263&type=chunk) [Certain Relationships and Related Party Transactions, and Director Independence](index=43&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20PARTY%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) Information on related party transactions and director independence is incorporated by reference from the 2021 annual meeting proxy statement - The required information for this item is incorporated by reference from the company's **2021 annual meeting proxy statement**[264](index=264&type=chunk) [Principal Accounting Fees and Services](index=43&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Principal accounting fees and services information is incorporated by reference from the 2021 annual meeting proxy statement - The required information for this item is incorporated by reference from the company's **2021 annual meeting proxy statement**[265](index=265&type=chunk) [Part IV](index=43&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=43&type=section&id=ITEM%2015.%20EXHIBITS%20AND%20FINANCIAL%20STATEMENT%20SCHEDULES) This section provides an index to the financial statements, schedules, and all exhibits filed with the annual report - This item provides an index to the financial statements, schedules, and all exhibits filed with the annual report[267](index=267&type=chunk)[269](index=269&type=chunk) [Financial Statements](index=47&type=section&id=Financial%20Statements) [Report of Independent Registered Public Accounting Firm](index=48&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Wipfli LLP issued an unqualified opinion on the financial statements, noting a Critical Audit Matter regarding complex equity transactions - The auditor, Wipfli LLP, provided an **unqualified opinion**, stating the financial statements are fairly presented in all material respects[280](index=280&type=chunk) - A Critical Audit Matter was identified related to the volume and complexity of the company's equity transactions, which required significant auditor judgment[284](index=284&type=chunk)[287](index=287&type=chunk) [Consolidated Financial Statements](index=50&type=section&id=Consolidated%20Financial%20Statements) Consolidated financial statements show significant 2020 improvements in cash to $9.88 million and equity to $9.57 million, despite a $2.96 million net loss Consolidated Balance Sheet Highlights | Account | Dec 31, 2020 ($) | Dec 31, 2019 ($) | | :--- | :--- | :--- | | Cash and cash equivalents | $9,883,796 | $283,341 | | Total Assets | $10,393,899 | $468,880 | | Total Liabilities | $825,047 | $2,043,436 | | Total Stockholders' Equity (Deficiency) | $9,568,852 | ($1,574,556) | Consolidated Statement of Operations Highlights | Account | 2020 ($) | 2019 ($) | | :--- | :--- | :--- | | Grant and collaboration revenue | $1,823,658 | $1,175,896 | | Total operating expenses | $4,640,473 | $3,548,389 | | Net loss | ($2,958,068) | ($2,370,629) | | Loss per common share | ($2.14) | ($781.87) | Consolidated Statement of Cash Flows Highlights | Account | 2020 ($) | 2019 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,750,570) | ($1,398,497) | | Net cash used in investing activities | ($156,791) | ($7,606) | | Net cash provided by financing activities | $12,507,816 | $1,429,743 | [Notes to Consolidated Financial Statements](index=54&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail 2020 accounting policies and events, including reverse stock splits, a $12.8 million public offering, and a $61.8 million NOL carryforward, with significant 2021 subsequent events - The company effected a **1-for-2000 reverse stock split** in January 2020 and a **1-for-20 reverse stock split** in September 2020[347](index=347&type=chunk) - On September 29, 2020, the company closed a public offering with gross proceeds of approximately **$12.8 million**[349](index=349&type=chunk) - As of December 31, 2020, the company had a federal net operating loss (NOL) carryforward of approximately **$61.8 million**[366](index=366&type=chunk) - Subsequent to year-end, in February 2021, the company closed a bought deal public offering with net proceeds of approximately **$9.4 million**[371](index=371&type=chunk)[372](index=372&type=chunk)
GeoVax Labs(GOVX) - 2020 Q3 - Earnings Call Transcript
2020-11-08 08:01
Call Start: 08:15 January 1, 0000 8:59 AM ET GeoVax Labs, Inc. (NASDAQ:GOVX) Q3 2020 Earnings Conference Call November 6, 2020, 08:15 AM ET Company Participants Scott Gordon - MD, CORE IR David Dodd - Chairman & CEO Mark Reynolds - CFO Mark Newman - CSO Conference Call Participants Jason McCarthy - Maxim Group Jeffrey Kraws - Crystal Research Associates Operator Good morning and welcome to the GeoVax Third Quarter 2020 Corporate Update Call. I am Cole with Chorus Call and will facilitate today's call. With ...