ORAGENICS INC
For the period ended Jun 30, 2024. Filed Aug 9, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 9, 2024
OGEN$0.35+0.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-15.
0001493152-24-019655
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-09.
0001493152-24-031000
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 98 previous paragraphs and 98 current paragraphs.
66 unchanged; 25 reworded; 7 added; 6 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 10 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (7)
Current report
On June 26, 2024, we announced the sale of 1.1 million shares of our common stock, par value $0.001, through a placement agreement with Dawson James Securities, Inc. (“Dawson James”) at an offering price per share of common stock of $1.00. The offering resulted in gross proceeds of $1.1 million before deducting placement agent fees and other estimated offering expenses payable by the Company. We also agreed to issue placement agent warrants (“Dawson James Warrants”) to purchase up to 5% of the aggregate number of securities sold in the offering with an exercise price 125% of the offering price of the common stock in the offering. The Dawson James Warrants are exercisable for five years from the date of closing the offering and are initially exercisable six months from the closing of the Offering.
Current report
Research and Development. Research and development expenses were $906,779 and $1,570,193, respectively, for the three and six-month periods ended June 30, 2024, compared to $2,006,696 and $3,679,272 for the comparable three and six-month periods ended June 30, 2023. This is a decrease of 54.8% and 57.3% for the comparable three and six-month periods ended June 30, 2024.
Current report
On August 8, 2024, the Company entered into an At-The-Market Issuance Sales Agreement (the “Sales Agreement”) with Ascendiant Capital Markets, LLC, as sales agent (the “Agent”), pursuant to which the Company may offer and sell through or to the Agent (the “ATM”) up to $10.0 million in shares of its common stock (the “Shares”) at-the-market. Shares offered and sold in the Offering are anticipated to be issued pursuant to the Company’s universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”) filed with the Securities and Exchange Commission (the “SEC”). Under the terms of the Sales Agreement, the Agent is entitled to a commission at a fixed rate of 3.0% of the gross proceeds from each sale of shares under the Agreement. There can be no assurances the Company will be able to raise any funds under the Sales Agreement.
Current report
On June 25, 2024, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Dawson James Securities Inc. (“Dawson James” or the “Placement Agent”) pursuant to which the Company engaged Dawson James as the placement agent for a registered public offering (the “Offering”) of an aggregate of 1,100,000 shares of the Company’s common stock, par value $0,001 (“Common Stock”). The offering price per share of Common Stock was $1.00. The Company agreed to pay the Placement Agent a placement agent fee in cash equal to 7.00% of the gross proceeds from the Offering, and to reimburse for certain out of pocket expenses, including legal fees not to exceed $75,000. In addition, the Company agreed to issue to the Placement Agent warrants to purchase up to five percent 5% of the aggregate number of securities sold in the Offering (“Dawson James Warrants”) with an exercise price of 125% of the offering price of the Common Stock in the Offering and exercisable for five years from the date of the closing of the Offering and are initially exercisable six months from the closing of the Offering.
Current report
The Offering resulted in gross proceeds to the Company of $1.1 million before underwriting discounts and commissions and other expenses payable by the Company were deducted.
Current report
The Placement Agency Agreement contains customary representations, warranties and agreements by the Company, conditions to closing, indemnification obligations of the Company, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties, and termination provisions.
Current report
Our common stock will continue to be listed on NYSE American during the plan period under the symbol “OGEN” with a “below compliance” indicator appended to our ticker symbol (with the added designation of “.BC”). Our receipt of the notification from NYSE American accepting the compliance Plan does not affect our business operations or our reporting requirements with the U.S. Securities and Exchange Commission.
Removed paragraphs (6)
Previous report
On March 1, 2024 we announced the closing of our previously announced underwritten public offering of 1.4 million shares of our common stock at a public offering price of $1.50 per share, with the gross proceeds of $2.1 million, before deducting underwriting discounts. We also granted the underwriters a 45-day option to purchase up to an additional 210,000 shares of its common stock at the public offering price, less discounts, to cover over-allotments (the “Over-Allotment Options”). In the 45 days following the transaction there were no Over-Allotment Options exercised.
Previous report
ThinkEquity and Laidlaw & Company (UK) Ltd. acted as joint book-running managers for the offering. The offering was made pursuant to an effective shelf registration statement that has been filed with the U.S. Securities and Exchange Commission (the “SEC”). The final prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.
Previous report
Research and Development. Research and development expenses were $663,414 for the three months ended March 31, 2024 compared to $1,672,576 for the three months ended March 31, 2023, a decrease of $1,009,162 or 60.3%.
Previous report
On March 1, 2024 we announced the closing of our previously announced underwritten public offering of 1.4 million shares of our common stock at a public offering price of $1.50 per share, providing gross proceeds of $2.1 million, before deducting underwriting discounts and our expenses incurred related to the offering. We also granted the underwriters a 45-day option to purchase up to an additional 210,000 shares of its common stock at the public offering price, less discounts, to cover over-allotments (the “Over-Allotment Options”). In the 45 days following the transaction there were no Over-Allotment Options exercised.
Previous report
ThinkEquity and Laidlaw & Company (UK) Ltd. acted as joint book-running managers for the offering. The offering was made pursuant to an effective shelf registration statement that has been filed with the U.S. Securities and Exchange Commission (the “SEC”). The final prospectus supplement relating to the offering was filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.
Previous report
The Notice has no immediate impact on the listing of the Company’s shares of common stock, par value $0.001 per share (the “Common Stock”), which will continue to be listed and traded on the NYSE American during this period, subject to the Company’s compliance with the other listing requirements of the NYSE American. The Common Stock will continue to trade under the symbol “OGEN”, but will have an added designation of “.BC” to indicate the status of the Common Stock as “below compliance”. The notice does not affect the Company’s ongoing business operations or its reporting requirements with the Securities and Exchange Commission.
Reworded paragraphs (25)
Previous wording
Currently research and development activities related to the nasal vaccine platform and our lantibiotic program are inactive, we will evaluate alternative opportunities for these programs moving forward as we continue to strengthen our focus and expertise on our intranasal drug delivery platform and drug candidates.
Current wording
Currently research and development activities related to the nasal vaccine platform and our lantibiotic program are inactive, and we will evaluate alternative opportunities for these programs moving forward as we continue to strengthen our focus and expertise on our intranasal drug delivery platform and drug candidates.
Previous wording
ONP-002 to date has been shown to be stable up to 104 degrees for 18-months. The drug candidate is spray-dry manufactured into a powder and filled into the novel intranasal device. The drug is then administered through the nasal passage from the device. The novel intranasal device is lightweight and should be easy to use in the field.
Current wording
ONP-002 to date has been shown to be stable up to 104 degrees for 18-months. The drug candidate is spray-dry manufactured into a powder and filled into the novel intranasal device. The drug is then administered through the nasal passage from a unique nasal delivery device. The novel intranasal device is lightweight and intended to be easy enough for self-administration use in the field or by medical personnel.
Previous wording
Safety studies have established a dosing regimen of 2X/day for fourteen days. The Phase 1 clinical trial was performed in Melbourne, Australia with a Contract Research Organization (CRO), Avance Clinical Pty Ltd and Nucleus Network Pty Ltd. The country of Australia provides a currency exchange advantage and a tax rebate at the end of our fiscal year from the Australian government on all Research and Development performed in Australia.
Current wording
Safety studies have established a dosing regimen of 2X/day for fourteen days. The Phase 1 clinical trial was performed in Melbourne, Australia with a Contract Research Organization (“CRO”), Avance Clinical Pty Ltd (“Avance Clinical”) and Nucleus Network Pty Ltd. The country of Australia provides a currency exchange advantage and a tax rebate at the end of our fiscal year from the Australian government on all Research and Development performed in Australia.
Previous wording
We anticipate preparing for Phase 2 clinical trials to further evaluate ONP-002’s safety and efficacy. Based on the Phase 1 data, we plan to apply for an Investigational New Drug application with the FDA and conduct a Phase 2 trial in the United States.
Current wording
We are preparing for Phase 2 clinical trials to further evaluate ONP-002’s safety and efficacy. Based on the Phase 1 data, we plan to apply for an Investigational New Drug application with the FDA and conduct a Phase 2 trial in the United States.
Previous wording
We anticipate a Phase 2 clinical trial will be performed administering ONP-002 intranasally in concussed patients 2x a day for up to fourteen days. The Phase 2a feasibility study is expected to be performed in Australia with a target initiation date in the second or third quarter of 2024 to be followed closely by a Phase 2b proof of concept study in the US.
Current wording
We anticipate a Phase 2 clinical trial will be performed administering ONP-002 intranasally in concussed patients 2x a day for up to fourteen days. The Phase 2a feasibility study is expected to be performed in Australia with a target initiation date in the fourth quarter of 2024 to be followed closely by a Phase 2b proof of concept study in the US.
Previous wording
In the three months ended March 31, 2024 we executed agreements with several vendors to advance our efforts toward starting Phase 2 clinical trials. Avance Clinical, a leading Contract Research Organization (CRO), was engaged to conduct Phase 2 clinical trials in Australia. Other key third party vendors also engaged to advance our progress were Upperton Pharma Solutions, Inotiv, Inc., and Charles River Laboratories Cleveland, Inc.
Current wording
In the six months ended June 30, 2024, we executed agreements with several vendors to advance our efforts toward starting Phase 2 clinical trials, including a contract with Avance Clinical to conduct Phase 2 clinical trials in Australia.
Previous wording
As part of the Company’s efforts to preserve cash resources, focus on the development of our ONP-002 concussion drug product candidate, the Company closed its facility in Alachua Florida where some of the work related to the lantibiotics program was performed and has paused all research and development activities related to our vaccine product candidate. Until the Company can secure additional capital and determine an alternative solution to continue these research and development programs, they will remain paused.
Current wording
As part of the Company’s efforts to preserve cash resources and focus on the development of our ONP-002 concussion drug product candidate, the Company closed its facility in Alachua Florida where some of the work related to the lantibiotics program was performed, and has paused all research and development activities related to our vaccine product candidate. Until the Company can secure additional capital and determine an alternative solution to continue these research and development programs, they will remain paused.
Previous wording
Our research and development expenses were $663,414 and $1,672,576 for the three months ended March 31, 2024 and 2023, respectively. In 2023 our research and development costs were tracked by our COVID vaccine program and our lantibiotics program, for the three months ended March 31, 2024 our research and development expenses were for the development of ONP-002. Due to limited resources, while we continue our development efforts, we have focused our research and development expenses to our ONP-002 drug and paused further development of our vaccine product and lantibiotics research until we can raise additional capital.
Current wording
Our research and development expenses were $1,570,193 and $3,679,272 for the six months ended June 30, 2024 and 2023, respectively. In 2023 our research and development costs consisted of our COVID vaccine program and our lantibiotics program, which were paused in 2023. For the six months ended June 30, 2024, our research and development expenses consisted of the costs related to the development of our ONP-002 neurologya sset. Due to limited resources, while we continue our development efforts, we have focused our research and development expenses to our ONP-002 drug and paused further development of our vaccine product and lantibiotics research until we can raise additional capital.
Previous wording
Our current product development strategy contemplates continued research and development of our ONP-002 product development. Continued research and development expenses are subject to available capital and our ability to raise the additional required capital. The lengthy process of completing pre-clinical studies, clinical trials; seeking regulatory approval; and expanding the potential claims we are able to make, requires expenditure of substantial resources. Any failure or delay in completing pre-clinical studies, clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenues and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Our current product candidate is not expected to be commercially available until we are able to obtain regulatory approval from the FDA or the regulatory authority in other jurisdictions where we may seek approval.
Current wording
Our current product development strategy contemplates continued research and development of our ONP-002 product. Continued research and development expenses are subject to available capital and our ability to raise the additional required capital. The lengthy process of completing pre-clinical studies, clinical trials, seeking regulatory approval, and expanding the potential claims we are able to make requires expenditure of substantial resources. Any failure or delay in completing pre-clinical studies, clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenues and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Our current product candidate is not expected to be commercially available until we are able to obtain regulatory approval from the FDA or the regulatory authority in other jurisdictions where we may seek approval.
Previous wording
Other income (expense) includes miscellaneous income, local business taxes, as well as interest income and expense. Interest income consists of interest earned on our cash and cash equivalents. The primary objective of our investment policy is capital preservation. Interest expense consists primarily of interest and costs associated with our indebtedness.
Current wording
Other income (expense) includes miscellaneous income as well as interest income and expense. Interest income consists of interest earned on our cash and cash equivalents. The primary objective of our investment policy is capital preservation. Interest expense consists primarily of interest and costs associated with our indebtedness.
Previous wording
Results of Operations for the Three Months Ended March 2024 and 2023
Current wording
Results of Operations for the Three and Six Months Ended June 2024 and 2023
Previous wording
Grant revenue. There was no grant revenue for the three months ended March 31, 2024. There was $17,024 for the three months ended March 31, 2023. This decrease was attributable to awards received for a small business innovation research grant that expired in the three-month period ended September 30, 2023.
Current wording
Grant revenue. There was no grant revenue for the three and six-month periods ended June 30, 2024. For the comparable three and six-month periods in 2023, there was $13,163 and $30,187 in grant revenue, respectively. This decrease was attributable to awards received for a small business innovation research grant that expired in the three-month period ended September 30, 2023.
Previous wording
This decrease was mainly driven by decreased costs associated with the development of our COVID vaccine product and our lantibiotics program. For the three months ended March 31, 2023 research and development expense related to our COVID vaccine product were approximately $1.4 million and primarily associated with costs for outside consultants. For the same three-month period our research and development costs related to our lantibiotic product were approximately $0.2 million. For the three-month period ended March 31, 2024 research and development expense related to ONP-002 was approximately $0.5 million, and approximately $0.1 million related to our vaccine product candidate.
Current wording
This decrease was mainly driven by decreased costs associated with the development of our COVID vaccine product and our lantibiotics program. For the three months ended June 30, 2023, research and development expenses for our COVID vaccine and lantibiotics programs were approximately $2.0 million and primarily associated with costs for outside consultants. For the three-month period ended June 30, 2024, research and development expense related to ONP-002 was approximately $0.9 million. For the six-month period ended June 30, 2024 and 2023, respectively our research and development expenses were approximately $1.4 million for our ONP-002 product and $0.1 million for our vaccine product, and approximately $3.7 million for our vaccine and lantibiotics programs.
Previous wording
General and Administrative. General and administrative expenses were $1,796,689 for the three months ended March 31, 2024 compared to $1,249,263 for three months ended March 31, 2023, an increase of approximately $547,426 or 43.8% This increase was primarily due to increased expenses related to:
Current wording
General and Administrative. General and administrative expenses were $1,399,221 for the three months ended June 30, 2024, compared to $1,115,785 for three months ended June 30, 2023, an increase of approximately $283,436 or 25.4%. General and administrative expenses for the six-month period ended June 30, 2024, were approximately $3,195,910 compared to $2,365,048 for the comparable six-month period in 2023, an increase of $830,862 or 35.1%. This increase was primarily due to increased expenses related to:
Previous wording
Other Income (Expense). Other income, net was $9,270 for the three months ended March 31, 2024 compared to $59,978 for the three months ended March 31, 2023, resulting in a decrease of $50,708 or 84.5%. The net change was primarily attributable to a reduction in interest income due to lower cash balances in interest earning accounts for the comparable periods.
Current wording
Other Income (Expense). Other income, net, was $910 for the three months ended June 30, 2024, compared to $58,732 for the three months ended June 30, 2023. For the six-month period ended June 30, 2024 and 2023, other income, net, was $10,180 and $118,710 respectively, resulting in a decrease of $108,530 or 91.4% for the comparable six-month periods. The net change was primarily attributable to a reduction in interest income due to lower cash balances in interest earning accounts for the comparable periods.
Previous wording
Since our inception, we have funded our operations primarily through the sale of equity securities in our initial public offering, the sale of equity securities and warrants in private placements, debt financing, warrant exercises, public offerings, and grants. During the three months ended March 31, 2024 and 2023 our operating activities used cash of $3,062,249 and $2,108,695 respectively. The increase is primarily driven by changes in net losses adjusted for non-cash items and changes in operating assets and liabilities. We had a working capital surplus of $1,534,515 and $2,067,593 at March 31, 2024 and December 31, 2023, respectively.
Current wording
Since our inception, we have funded our operations primarily through the sale of equity securities in our initial public offering, the sale of equity securities and warrants in private placements, debt financing, warrant exercises, public offerings, and grants. During the six months ended June 30, 2024 and 2023, our operating activities used cash of $4,608,778 and $4,685,323 respectively. The decrease is primarily driven by changes in net losses adjusted for non-cash items and changes in operating assets and liabilities. We had a working capital surplus of $235,646 and $2,067,593 at June 30, 2024 and December 31, 2023, respectively.
Previous wording
During the three months ended March 31, 2024 and 2023, our financing activities provided cash of $1,652,737 and used cash of $159,750 respectively. The cash provided by financing activities during the three months ended March 31, 2024 was primarily due to net proceeds from our underwritten public offering.
Current wording
During the six months ended June 30, 2024 and 2023, our financing activities provided cash of $2,473,898 and used cash of $267,640 respectively. The cash provided by financing activities during the six months ended June 30, 2024 was primarily due to net proceeds from our underwritten public offerings.
Previous wording
The Company has made several changes to reduce cash used in operations until additional capital can be obtained. These changes include a reduction in staffing and a reduction in research and development activity. These changes have positively impacted the forecast of cash resources available for operations, which we believe will allow us to fund our operating plan through the third quarter of 2024.
Current wording
The Company has made several changes to reduce cash used in operations until additional capital can be obtained. These changes include a reduction in staffing and a reduction in research and development activity. These changes have positively impacted the forecast of cash resources available for operations, which we believe will allow us to fund our operating plan through the fourth quarter of 2024.
Previous wording
On February 24, 2023 the Company entered into an ATM with Ladenburg Thalmann & Co. Inc (“Ladenburg”) to sell shares of its common stock. The Company did not issue any shares of common stock under its ATM with Ladenburg during the three-month periods ended March 31, 2023 and 2024. The Company did not sell any shares through the ATM program while it was active. The ATM program with Ladenburg terminated on January 30, 2024.
Current wording
On February 24, 2023 the Company entered into an ATM with Ladenburg Thalmann & Co. Inc (“Ladenburg”) to sell shares of its common stock. The Company did not issue any shares of common stock under its ATM with Ladenburg during the six-month periods ended June 30, 2024 and 2023. The Company did not sell any shares through the ATM program while it was active. The ATM program with Ladenburg terminated on January 30, 2024.
Previous wording
In July of 2023, we entered into a short-term note payable for $611,109 bearing interest at a rate of 9.55% to finance the renewals of the directors’ and officers’ liability, employment practices liability, products liability, cyber liability, and other liability policies. Principal and interest payments on the note began in August of 2023 and continue through May of 2024 based on straight-line amortization over the 10-month period.
Current wording
In July of 2023, we entered into a short-term note payable for $611,109 bearing interest at a rate of 9.55% to finance the renewals of the directors’ and officers’ liability, employment practices liability, products liability, cyber liability, and other liability policies. Principal and interest payments on the note began in August of 2023 and continued through May of 2024 based on straight-line amortization over the 10-month period.
Previous wording
On April 18, 2024, we received Notice from the NYSE American that we are no longer in compliance with NYSE American’s continued listing standards. Specifically, we are not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. We reported stockholders’ equity of $3.2 million as of December 31, 2023, and $2.6 million as of March 31, 2024. Additionally, we have reported losses from continuing operations and/or net losses in our five most recent fiscal years ended December 31, 2023.
Current wording
On April 18, 2024, we received Notice from the NYSE American that we are no longer in compliance with NYSE American’s continued listing standards. Specifically, we are not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. Section 1003(a)(ii) requires a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires a listed company to have stockholders’ equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. We reported stockholders’ equity of $3.2 million as of December 31, 2023, and $1.3 million as of June 30, 2024. Additionally, we have reported losses from continuing operations and/or net losses in our five most recent fiscal years ended December 31, 2023.
Previous wording
The Notice further provides that we must submit a plan of compliance (the “Plan”) by May 18, 2024 addressing how we intend to regain compliance with the continued listing standards by October 18, 2025. The Plan is required to include specific milestones, quarterly financial projections and details related to any strategic initiatives we plan to complete.
Current wording
The Notice further provides that we must submit a plan of compliance (the “Plan”) by May 18, 2024 (the “Deadline”) addressing how we intend to regain compliance with the continued listing standards by October 18, 2025. The Plan is required to include specific milestones, quarterly financial projections and details related to any strategic initiatives we plan to complete.
Previous wording
Management has begun to prepare its Plan for submission to the NYSE American by the May 18, 2024 deadline. If the NYSE American accepts our Plan, we will be able to continue our listing during the Plan period and we will be subject to continued periodic review by the NYSE American staff. If the Plan is not submitted, or not accepted, or is accepted but we are not in compliance with the continued listing standards by October 18, 2025 or if we do not make progress consistent with the Plan during the Plan period, we will be subject to delisting procedures as set forth in the NYSE American Company Guide.
Current wording
We submitted the Plan by the Deadline and on June 18, 2024 we were notified by the NYSE American that our Plan to regain compliance with NYSE American’s continued listing standards had been accepted, as part of the acceptance we were granted a plan period through October 18, 2025. During the plan period, we will be subject to quarterly monitoring for compliance with the plan. If we do not regain compliance with NYSE American’s listing standards by October 18, 2025, or if we do not make progress consistent with our plan, the NYSE American may initiate delisting proceedings.
Previous wording
Our capital requirements for the remainder of 2024 will depend on numerous factors, including our ability raise additional capital including through possible joint ventures and/or partnerships, we expect to incur substantial expenditures to further develop or commercialize our technologies including continued increases in costs related to research, nonclinical testing and clinical trials, as well as costs associated with our capital raising efforts and being a public company. We will require substantial funds to conduct research and development and nonclinical and Phase 2 clinical testing of our licensed, patented technologies and to develop sublicensing relationships for the Phase 2 and 3 clinical testing and manufacture and marketing of any products that are approved for commercial sale. Our plans include seeking both equity and debt financing, alliances or other partnership agreements with entities interested in our technologies, or other business transactions that would generate sufficient resources to ensure continuation of our operations and research and development programs.
Current wording
Our capital requirements for the remainder of 2024 will depend on numerous factors, including our ability raise additional capital including through possible joint ventures and/or partnerships. We expect to incur substantial expenditures to further develop or commercialize our technologies including continued increases in costs related to research, nonclinical testing and clinical trials, as well as costs associated with our capital raising efforts and being a public company. We will require substantial funds to conduct research and development and nonclinical and Phase 2 clinical testing of our licensed, patented technologies and to develop sublicensing relationships for the Phase 2 and 3 clinical testing and manufacture and marketing of any products that are approved for commercial sale. Our financing plans include seeking both equity and debt financing, alliances or other partnership agreements with entities interested in our technologies, or other business transactions that would generate sufficient resources to ensure continuation of our operations and research and development programs.
Previous wording
Our current available cash and cash equivalents, provide us with limited liquidity. We believe our existing cash will allow us to fund our operating plan through the third quarter of 2024. As a result, we have implemented certain cost-saving initiatives, including reducing our efforts and staff focused on our lantibiotics program and our vaccine product candidate, which are expected to negatively impact the development of these programs. See, “Risk Factors.” We expect to manage the timing of our development expenditures and to continue to seek additional funding for our operations. Any required additional capital may not be available on reasonable terms, if at all. If we were unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned clinical testing, research and development and commercialization activities, which could harm our business. The sale of additional equity or debt securities may result in additional dilution to our shareholders. If we raise additional funds through the issuance of debt securities or preferred stock, these securities could have rights senior to those of our common stock and could contain covenants that would restrict our operations. We also will require additional capital beyond our currently forecasted amounts for example, as we seek to move forward with the development of ONP-002 we will require additional capital. In addition, we continue to pursue other non-dilutive opportunities for our COVID-19 research and development funding opportunities through governmental and nongovernmental sources, as well as potential research collaboration arrangements with academic institutions and other commercial partners. Our ability to advance the development of our ONP-002 concussion candidate at our currently anticipated pace, is dependent upon our ability to secure additional capital resources through these funding opportunities or an alternative capital raise, such as an equity or debt financing or other strategic business collaboration.
Current wording
Our current available cash and cash equivalents provide us with limited liquidity. We believe our existing cash will allow us to fund our operating plan through the fourth quarter of 2024. As a result, we have implemented certain cost-saving initiatives, including reducing our efforts and staff focused on our lantibiotics program and our vaccine product candidate, which are expected to negatively impact the development of these programs. See, “Risk Factors.” We expect to manage the timing of our development expenditures and to continue to seek additional funding for our operations. Any required additional capital may not be available on reasonable terms, if at all. If we were unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned clinical testing, research and development and commercialization activities, which could harm our business. The sale of additional equity or debt securities may result in additional dilution to our shareholders. If we raise additional funds through the issuance of debt securities or preferred stock, these securities could have rights senior to those of our common stock and could contain covenants that would restrict our operations. We also will require additional capital beyond our currently forecasted amounts, for example, as we seek to move forward with the development of ONP-002 we will require additional capital. In addition, we continue to pursue other non-dilutive opportunities for our COVID-19 research and development funding opportunities through governmental and nongovernmental sources, as well as potential research collaboration arrangements with academic institutions and other commercial partners. Our ability to advance the development of our ONP-002 concussion candidate at our currently anticipated pace, is dependent upon our ability to secure additional capital resources through these funding opportunities or an alternative capital raise, such as an equity or debt financing or other strategic business collaboration.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We intend to use the net proceeds from the offering to fund the continued development of ONP-002, and for general corporate purposes and working capital.