OCEA 10-K & 10-Q changes, risk factors and insider trading
Ocean Biomedical, Inc. · OTC · Pharmaceutical Preparations · CIK 1869974 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Largest changes
“Specifically, the Company’s material weakness was that its management does not have adequate staffing in its accounting department and has not yet designed and implemented the appropriate processes and internal controls to support accurate and timely financial reporting.”see in full comparison
“Specifically, the Company’s material weaknesses were due to:”see in full comparison
We are required to disclose changes made in our internal controls and procedures on a quarterly basis and our management is required to assess the effectiveness of these controls annually.see in full comparisonInIfaddition,weourareindependentnoregisteredlongerpublicconsideredaccountinganfirmEGC, then we will be required toattesthave antoaudit of the effectiveness ofourinternal controls over financialreporting pursuant to Section 404, however they will not be required to do so for so long as we are an EGC.reporting. We could be an EGC for up to five years. An independent assessment of the effectiveness of our internal controls over financial reporting could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls over financial reporting could lead to restatements of our financial statements and require us to incur the expense of remediation.
We identifiedsee in full comparisonamaterialweaknessweaknesses in the Company’s internal control over financial reporting. If our remediation ofthisthese materialweaknessweaknesses is not effective, or if we experience additional material weaknesses or otherwise fail to maintain an effective system of internalinternalcontrols over financial reporting in the future, we may not be able to accurately report our financial condition or results of operations.
Full comparison: every changed paragraph (16)
Ocean’s
independent registered public accounting firm included an explanatory paragraph in its audit report on Ocean’s consolidated financial
statements asfor ofthe year ended December 31, 2023,2024, stating that Ocean’s working capital deficit and anticipated losses from operations and Ocean’s
need to obtain additional capital raised substantial doubt about Ocean’s ability to continue as a going concern.
To
the extent that we raise additional capital through the sale of common stock or securities convertible or exchangeable into common stock,
your ownership interest will be diluted. In addition, any debt financing may subject us to fixed payment obligations and covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing
arrangements with third parties, we may have to relinquish certain valuable intellectual property or other rights to our product candidates,
technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. We also may be
required to seek collaborators for any of our product candidates at an earlier stage than otherwise would be desirable or relinquish
our rights to product candidates or technologies that we otherwise would seek to develop or commercialize ourselves. Market volatility
and unforeseen events, such as the COVID-19 pandemic and the conflict between Russia and Ukraine, could also adversely impact our ability
to access capital as and when needed. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us,
we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates
or one or more of our other research and development initiatives. Any of the above events could significantly harm our business, prospects,
financial condition and results of operations and cause the price of our common stock to decline.
Any
third parties conducting aspects of our preclinical studies, clinical trials or manufacturing process will not be our employees and,
except for remedies that may be available to us under our agreements with such third parties, we cannot control whether or not they devote
sufficient time and resources to our preclinical studies and clinical programs. These third parties may also have relationships with
other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development
activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual
duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the preclinical or clinical
data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons or if due
to federal or state orders or absenteeism due to the COVID-19 pandemic or other such crises they are unable to meet their contractual
and regulatory obligations, our development timelines, including clinical development timelines, may be extended, delayed or terminated
and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates.
As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase
and our ability to generate revenue could be delayed.
Our
internal computer systems and those of our current and any future collaborators and other contractors or consultants are vulnerable to
damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Such
a material system failure, accident or security breach could result in a disruption of our development programs and our business operations,
whether due to a loss of our trade secrets or other proprietary information or other similar disruptions. For example, the loss of clinical
trial data from an of our clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs
to recover or reproduce the data. Additionally, during the COVID-19 pandemic, there have beenwere a number of security breaches relating
to companies providing or developing treatments or vaccines related to COVID-19. To the extent that any disruption or security breach
were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information,
we could incur liability, our competitive position could be harmed and the further development and commercialization of our product candidates
could be delayed.
We
identified a material weaknessweaknesses in the Company’s internal control over financial reporting. If our remediation of thisthese material
weaknessweaknesses is not effective, or if we experience additional material weaknesses or otherwise fail to maintain an effective system of
internal internal
controls over financial reporting in the future, we may not be able to accurately report our financial condition or results
of operations.
In
connection with Legacy Ocean’s preparation and the audits of its historical financial statements, and the Company’s preparation
and the audit of its financial statements as of December 31, 2024 and 2023, the Company
identified a material weaknessweaknesses as defined under
the Securities Exchange Act of 1934, as amended, or the Exchange Act, and by the
Public Company Accounting Oversight Board (United States)
in its internal control over financial reporting. A material weakness is a
deficiency, or a combination of deficiencies, in internal
control over financial reporting, such that there is a reasonable
possibility that a material misstatement of the company’s financial
statements will not be prevented or detected on a timely
basis.
Specifically, the Company’s material weaknesses were due to:
Specifically,
the Company’s material weakness was that its management does not have adequate staffing in its accounting department and has not
yet designed and implemented the appropriate processes and internal controls to support accurate and timely financial reporting.
The
Company is working to remediate the material weaknessweaknesses and is taking steps to strengthen its internal control over financial reporting
such as the Company’s hiring of Jolie Kahn as its Chief Financial Officer in the first quarter of 2024. Additionally, the Company
plans to further develop and implement formal policies, processes and documentation procedures relating to financial reporting, including
the oversight of third-party service providers. The actions that the Company is taking are subject to ongoing executive management review.
If the Company is unable to successfully remediate the material weakness,weaknesses, or if in the future, we identify further material weaknesses
in our internal controls over financial reporting, we may not detect errors on a timely basis, and our financial statements may be materially
misstated. We or our independent registered public accounting firm may not be able to conclude on an ongoing basis that we have effective
internal control over financial reporting, which could harm our operating results, cause investors to lose confidence in our reported
financial information and cause the trading price of our stock to fall. In addition, as a public company, we will be required to file
accurate and timely quarterly and annual reports with the SEC under the Exchange Act. Any failure to report our financial results on
an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from Nasdaq or other adverse consequences that
would materially harm our business. In addition, we could become subject to investigations by Nasdaq, the SEC, and other regulatory authorities,
and become subject to litigation from investors and stockholders, which could harm our reputation and our financial condition, or divert
financial and management resources from our core business.
Effective
internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure
controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered
in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection
with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal
controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to
our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors
to lose confidence in our reported financial information, which could have a negative effect on the trading price of our stock.
We
are required to disclose changes made in our internal controls and procedures on a quarterly basis and our management is required to
assess the effectiveness of these controls annually. InIf addition,we ourare independentno registeredlonger publicconsidered accountingan firmEGC, then we will be required
to attesthave
an toaudit of the effectiveness of our internal controls over financial reporting pursuant to Section 404, however they will not be required
to do so for so long as we are an EGC.reporting. We could be an EGC for up to five years. An independent assessment of the effectiveness of our
internal controls over financial reporting could detect problems that our management’s assessment might not. Undetected material
weaknesses in our internal controls over financial reporting could lead to restatements of our financial statements and require us to
incur the expense of remediation.
Since
its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA,
and we expect there will be additional challenges and amendments to the ACA in the future. Various portions of the ACA are currently
undergoing legal and constitutional challenges in the United States Supreme Court. It is unclear how such litigation and other efforts
to repeal and replace the ACA will impact the ACA and our business. In addition, the formerfirst Trump administration issued various Executive
Orders which eliminated cost sharing subsidies and various provisions that would impose a fiscal burden on states or a cost, fee, tax,
penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.
Additionally, Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA. It is unclear
whether the ACA will be overturned, repealed, replaced, or further amended. We cannot predict what affect further changes to the ACA
would have on our business.
Our
principal stockholders and management own a significant percentage of our Commoncommon stock and are able to exert significant control
over matters
subject to stockholder approval.
Additionally,
we qualify as a “smaller reporting company” as defined in Item 10(f)(1)7A of Regulation S-K promulgated by the SEC. Smaller
reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years
of audited financial statements. We will remain a smaller reporting company for so long as the market value of its common stock held
by non-affiliates is less than $250.0 million measured on the last business day of its second fiscal quarter, or its annual revenue is
less than $100.0 million during the most recently completed fiscal year and the market value of its common stock held by non-affiliates
is less than $700.0 million measured on the last business day of our second fiscal quarter. To the extent we take advantage of such reduced
disclosure obligations, it may also make comparison of its financial statements with other public companies difficult or impossible.
We
have the ability to redeem outstanding public warrants at any time after they become exercisable and prior to their expiration, at a
price of $0.01 per warrant, provided that the last reported sales price of our common stock equals or exceeds $18.00 per share for any
20 trading days within a 30-trading day period ending on the third trading day prior to the date we give notice of redemption. If and
when the public warrants become redeemable by us, we may exercise its redemption right even if it is unable to register or qualify the
underlying securities for sale under all applicable state securities laws. Redemption of the outstanding public warrants could force
the holders (i) to exercise their public warrants and pay the exercise price therefor at a time when it may be disadvantageous for them
to do so, (ii) to sell their public warrants at the then-current market price when you might otherwise wish to hold your public warrants
or (iii) to accept the nominal redemption price which, at the time the outstanding public warrants are called for redemption, is likely
to be substantially less than the market value of their public warrants. None of the private placement warrants will be redeemable by
us so long as they are held by their initial purchasers or their permitted transferees.
Our
private placement warrants are exercisable for 5,411,000 shares of common stock at $11.50 per share and our public warrants are exercisable
for 5,250,000 shares of common stock at $11.50 per shares.share. The Second Street Warrants are exercisable for 511,712 shares of common stock
at an exercise price of $8.06 per share, 102,342 shares of common stock at an exercise price of $7.47 per share and 75,000 shares of
common stock at an exercise price of $10.34. The additional shares of our common stock issued upon exercise of our warrants will result
in dilution to the then existing holders of our common stock and increase the number of shares eligible for resale in the public market.
Sales of substantial numbers of such shares in the public market could adversely affect the market price of our common stock.
Management's Discussion & Analysis (MD&A)
Largest changes
“On November 13, 2024, the Company received a notice of default with regard to its 2023 promissory note with EF Hutton, which alleges that $2.1 million is due under the promissory note, consisting of the unpaid principal balance of $1.6 million, plus accrued and unpaid interest of $0.5 million.”see in full comparison
“As the Company experiences market conditions which have made it difficult to raise capital for pre clinical pharmaceutical and other life science businesses, it is considering alternatives to expand its business into other technology driven markets as a method of driving revenue and providing capital to further fund its biotech expansion efforts. As such it is exploring opportunities in different business segments including but not limited to data centers and artificial intelligence and other related areas.”see in full comparison
“Other income (expense) for the fiscal year ended December 31, 2024 decreased by approximately $98.6 million compared to the fiscal year ended December 31, 2023 primarily driven by: …”see in full comparison
“Other income/(Loss) for the fiscal year ended December 31, 2023 increased by approximately $103.0 million compared to the fiscal year ended December 31, 2022 primarily driven by the costs incurred with respect to the Business Combination and the debt financing, including: (i) the loss on the Backstop Forward Purchase Agreement asset of approximately $62.6 million; (ii) stock issuance loss of approximately $12.7 million relating to the fair value of the 1,200,000 Share Consideration Shares issued to the Backstop Parties in February 2023; …”see in full comparison
“The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with our audited consolidated financial statements and the notes related thereto which follow Item 16 of this Annual Report on Form 10-K. Certain information contained in the discussion and analysis set forth below includes forward-looking statements. …”see in full comparison
General and administrative expenses for the fiscal year ended December 31,see in full comparison20232024increaseddecreased by approximately$1.8$5.7 million, compared to the fiscalfiscalyear ended December 31,2022,2023, primarily driven by (i)anaincrease in accounting fees of approximately $1.3 million; (ii) an increasedecrease in legal fees of approximately$1.6$2.8 million; (ii) a decrease in accounting fees of approximately $0.7 million; (iii)anaincreasedecrease in insurance expense of approximately$0.7$0.2 million; (iv)an increasea decrease in compensation expense of approximately $1.0 million;and(v)anaincreasedecrease in stock-based compensation of approximately $0.5 million; and (vi) a decrease in outside servicesof approximately $0.6 million, partially offset by a decrease of stock-based compensation expense of approximately $2.9 millionand other expenses of approximately$0.4$0.5 million.
Full comparison: every changed paragraph (31)
The following discussion and analysis of the Company’s financial condition and results of operations should be read in conjunction with our audited consolidated financial statements and the notes related thereto which follow Item 16 of this Annual Report on Form 10-K. Certain information contained in the discussion and analysis set forth below includes forward-looking statements. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those set forth under “Cautionary Note Regarding Forward-Looking Statements,” “Item 1A. Risk Factors” and elsewhere in this Annual Report on Form 10-K.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS On February 14, 2023, the registrant consummated the previously announced business combination (the “Business Combination”) pursuant to that certain Agreement and Plan of Merger, dated August 31, 2022, as amended on December 5, 2022 by Amendment No. 1 (as amended, the “Business Combination Agreement”), by and among Ocean Biomedical, Inc., formerly known as Aesther Healthcare Acquisition Corp. (the “Company”), AHAC Merger Sub, Inc., a Delaware corporation (“Merger Sub”), Aesther Healthcare Sponsor, LLC (the “Sponsor”), in its capacity as purchaser representative, Ocean Biomedical Holdings, Inc., formerly known as Ocean Biomedical, Inc., a Delaware corporation (“Legacy Ocean”), and Dr. Chirinjeev Kathuria, in his capacity as seller representative. In connection with the closing of the Business Combination (the “Closing”), the Company changed its name from “Aesther Healthcare Acquisition Corp.” to Ocean Biomedical, Inc.” References to the “Company”, “Ocean Biomedical”, “we”, “us” and “our” refer to the Legacy Ocean prior to the Closing of the Business Combination and Ocean Biomedical, Inc., formerly known as Aesther Healthcare Corp., on a consolidated basis with Legacy Ocean, for periods after the Closing of the Business Combination.
In
February 2022, we entered into a Loan Agreement (the “Second Street Loan”) with Second Street Capital, LLC (“Second
Street Capital”), pursuant to which we borrowed $0.6 million. The Second Street Loan accrues interest at the rate of 15% per annum,
with principal and interest due at maturity. We issued to Second Street Capital a warrant to purchase 312,500 shares of Legacy Ocean
common stock, with an exercise price of $11.00 per share, exercisable until February 22, 2026. For a period of 180 days from the closing
of our next financing, Second Street Capital has the right to put the warrants to the Company in exchange for a payment of $0.3 million.
We were originally required to repay the Second Street Loan on the earlier of (i) 5 business days after our next financing or (ii) November
18, 2022. We recognized as interest expense in Other income/(lossexpense) $0.3 million for the put option in the first quarter of 2022.
In
MayApril 2022, we entered into a second the Second Street Loan Agreement2 with Second Street Capital (the “Second Street Loan 2”), Capital,
pursuant to which
the Company borrowed $0.2 million. The Second Street Loan 2 accrues interest at the rate of 15% per annum, with
principal and interest
due at maturity. We issued to Second Street Capital a warrant to purchase 62,500 shares of Legacy Ocean
common stock, with an exercise
price of $11.00 per share, exercisable until February 22, 2026. There is no put option associated
with this loan. We were originally
required to repay the Second Street Loan 2 on the earlier of (i) 5 business days after our next
financing or (ii) November 18, 2022.
We recognized as interest expense in Other income/(lossexpense) $0.4 million in the second quarter of
2022 for the warrants issued based on
the estimated fair value of the awards on the date of grant.
On
September 30, 2022, the Second Street Loan and Second Street Loan 2 were amended whereas the maturity dates were extended from
November November
18, 2022 to December 30, 2022. We were required to repay the principal and accrued interest of the Second Street Loan and
Second Street
Loan 2 the earlier of (i) 5 business days after our next financing or closing of the Business Combination or (ii)
December 30, 2022.
In consideration of the extensions, we issued to Second Street Capital a warrant to purchase 75,000 shares of
Legacy Ocean common stock
with an exercise price of $10.20 per share exercisable until September 30, 2026. WeIn September 2022, we
recognized as interest expense in Otherother income/(lossexpense)
$0.4 million for the warrants issued based on the estimated fair value of
the awards on the date of grant.
We
recognized a total expense in the amount of $1.1 million as interest expense in Otherother income/(lossexpense) for the fiscal year ended December
31, 2022 for the put option and warrants issued to Second Street Capital of which $0.3 million was for the put option and $0.8 million
was for the warrants issued for the year ended December 31, 2022. The warrants issued to Second Street Capital were converted into warrants
to purchase our common stock, post-closing of the Business Combination, as described below under “Closing of Business Combination.”
Effective
February 15, 2023, the Second Street Loan and Second Street Loan 2 were further amended whereas the maturity dates were extended from
February 15, 2023 to March 31, 2023. We were required to repay the principal and accrued interest of the Second Street Loan and Second
Street Loan 2 the earlier of (i) 5 business days after our next financing or (ii) March 31, 2023. In consideration of the extensions,
we issued to Second Street Capital a warrant to purchase 75,000 shares of our common stock with an exercise price of $10.34 per share
exercisable until March 31, 2028. An extension fee of $0.1 million was recorded and $0.2 million was recognized as interest expense in
Otherother income/(lossexpense) in our consolidated financial statements for the quarter ended March 31, 2023.
Effective
March 29, 2023, we entered into a Loan Agreement with Second Street Capital (the “March Second Street Loan”) pursuant to
which we could borrow up to $1.0 million to pay certain accrued expenses. Of this amount, we borrowed $0.7 million. The loan bears interest
at 15% per annum and is due as described under “Short-Term Loans” below. We issued a warrant to the lender for 200,000 shares
of our common stock, exercisable for five years at an exercise price of $10.34 and will pay up to $0.2 million in loan fees at maturity.
Since the Company only borrowed $0.7 million, the loan fee due is $0.1 million at maturity. The estimated fair value of the warrant was
$0.7 million that is amortized over the term of the loan. The Company recognized $50 thousand as interest expense in Otherother income/(lossexpense)
in its consolidated financial statements for the fiscal year ended December 31, 2023.
Effective
March 31, 2023, the Second Street Loan and the Second Street Loan 2 were further amended to extend the maturity dates to May 31, 2023,
and we are currently required to repay the loans as described under “Short-Term Loans” below. In addition, an additional
warrant was issued to purchase 150,000 shares of our common stock with an exercise price of $11.50 and a loan fee of $0.1 million was
charged. We recognized as interest expense in Otherother income/(lossexpense) $0.5 million for the warrants issued based on the estimated fair value
of the awards on the date of grant in our consolidated financial statements for the fiscal year ended December 31, 2023.
Effective
March 28, 2023, we entered into a Loan Agreement (the “McKra Loan”) with McKra Investments III (“McKra”) pursuant
pursuant to which we borrowed $1.0 million. We issued a warrant to purchase 200,000 shares of our common stock, with an exercise
price of $10.34
per share, exercisable until March 27, 2028. We are required to pay a $0.2 million loan and convenience fee due upon
repayment of the
loan. Repayment of the loan is due as described under “Short-Term Loans” below. The Company has to
amortize the fair value
calculation over the term of the loan on a straight-line basis by days. The estimated fair value of the
warrant was $0.8 million that
is amortized over the term of the loan. The Company recognized $0.3 million as interest expense in
Other other income/(lossexpense) in its consolidated
financial statements for the fiscal year ended December 31, 2023, including $0.2 million
related to the amortization of debt issuance
costs.
We
have incurred significant operating losses since inception. Our ability to generate product revenues sufficient to achieve profitability
will depend heavily upon the successful development and eventual commercialization of one or more of our current products or any future
products. Our net operating losses were $10.2$9.5 million and $16.1$114.5 million for the fiscal year ended December 31, 20232024 and 2022,2023, respectively.
As of December 31, 20232024 and December 31, 2022,2023, we had an accumulated deficit of $196.1$205.5 million and $81.6$196.1 million, respectively. Our
current current
liabilities are $30.0$33.9 million and $12.7$30.0 million as of December 31, 20232024 and December 31, 2022,2023, respectively. The current liabilities
consisted of accrued expenses including transaction costs, accounting and legal fees, accrued research and development costs, and short-term
loans. We expect that our expense and capital requirements will increase substantially in connection with ongoing activities to commercialize
our products in the future.
Future Operations
As the Company experiences market conditions which have made it difficult to raise capital for pre clinical pharmaceutical and other life science businesses, it is considering alternatives to expand its business into other technology driven markets as a method of driving revenue and providing capital to further fund its biotech expansion efforts. As such it is exploring opportunities in different business segments including but not limited to data centers and artificial intelligence and other related areas.
At
Closing, the underwriters for AHAC’s initial public offering (“IPO”) agreed to defer payment of $3.2 million of deferred
underwriting discounts otherwise due to them until November 14, 2023, pursuant to the terms of a promissory note (the “Underwriter
Promissory Note”). The deferred amounts bear interest at 9% per annum and 24% per annum following an event of default under the
promissory note. The Company has a right to pay up to fifty percent (50%) of the principal and interest due on this promissory note using
the common stock of the Company at a price per share of $10.56. The remaining fifty percent (50%) of the principal and interest due on
this promissory note must be paid in cash. As of December 31, 2023 the Company had not repaid the Underwriter Promissory Note and the
outstanding balance of $3.2 million is recorded as a short-term loan in the consolidated financial statements. The Company recorded $0.4
million and $0.3
million of interest expense on the outstanding balance in the Company’s consolidated financial statements for
the fiscal yearyears ended
December 31, 2023.2024 and 2023, respectively.
On March 4, 2024, the Company converted the convertible portion of the Underwriter Promissory Note into 169,582 restricted shares of its common stock at the conversion price of $10.56. The principal amount converted was $1.6 million, plus $0.2 million of accrued interest thereon. As of December 31, 2024, the Company had not repaid any of remaining principal balance of $1.6 million, which is recorded as a short-term loan in the consolidated financial statements.
On November 13, 2024, the Company received a notice of default with regard to its 2023 promissory note with EF Hutton, which alleges that $2.1 million is due under the promissory note, consisting of the unpaid principal balance of $1.6 million, plus accrued and unpaid interest of $0.5 million.
We
will also pay Elkurt developmental and commercialization milestone payments for each of the Initial Brown License Agreements ranging
from $50,000 for the filing of an IND, or the equivalent outside of the United States, to $0.3 million for enrollment of the first patient
in a Phase 3 clinical trial in the United States or the equivalent outside of the United States. We are also responsible for reimbursement
of patent costs. We recorded reimbursement of patent costs as general and administrative costs in the statements of operations as incurred.
For the fiscal years ended December 31, 20232024 and 2022,2023, the Company incurred reimbursed patent costs expenses to Brown University in the
amount of $0.1 million andeach $0.2 million, respectively.year. As of December 31, 2024 and 2023, the Company reflected a balance due of $0.1 million in
accrued expenses – related parties on its consolidated balance sheet.sheets.
The
contract term for the Brown Anti-PfGARP Small Molecules License Agreement continues until the later of the date on which the last valid
claim expires or ten years. Either party may terminate the Brown Anti-PfGARP Small Molecules License Agreement in certain situations,
including Elkurt being able to terminate the Brown Anti-PfGARP Small Molecules License Agreement at any time and for any reason after
NovemberDecember 1,31, 20232025 if we have not raised at least $10 million in equity financing by then.
For
the Rhode Island License Agreement, we are required to pay Elkurt $0.1 million, due within 45 days of an equity financing of at
least $10
million or May 1, 2022, whichever comes first, and beginning on January 1, 2022, an additional $3,000 annual maintenance
fee thereafter,
until January 1, 2028, at which point the annual maintenance fee will become $4,000 per year. We are also required
to pay Elkurt 1.5%
of net sales under the Rhode Island License Agreement. In addition, we must pay Elkurt 25% of all non-royalty
sublicense income prior
to the first commercial sale, and 10% of non-royalty sublicense income thereafter, in the event that we
enter into sublicenses for the
subject intellectual property. If net sales or non-royalty sublicense income are generated from
know-how products, the amounts otherwise
due (royalty or non-royalty sublicense income) shall be reduced by 50%. We will also pay
Elkurt developmental and commercialization milestone
payments under the Rhode Island License Agreement, ranging from $50,000 for the
filing of an IND, or the equivalent outside of the United
States, to $0.3 million for enrollment of the first patient in a Phase 3
clinical trial in the United States or the equivalent outside of
the United States. For the fiscal years ended December 31, 20232024 and 2022,
2023, the Company has incurred reimbursed patent costs expenses to
Rhode Island Hospital in the amount of $0.1 million andeach $0.3 million, respectively.year. As
of December 31, 2024 and 2023, the Company reflected a
balance due of $0.1 million and $0.2 millionmillion, respectively in accrued
expenses – related parties on its consolidated balance sheet. With respect to a July 19, 2024 amendment, we paid Rhode Island
Hospital $0.1 million.
The
contract term for the Rhode Island License Agreement began February 1, 2020 and will continue until the later of the date on which the
last valid claim expires or fifteen years. Either party may terminate the Rhode Island License Agreement in certain situations, including
Elkurt being able to terminate the license agreement at any time and for any reason by May 1, 2022, if we have not raised at least $10
million in equity financing by then. Currently, the Rhode Island License Agreement is still in effect and the license agreement has been
sublicensed to our subsidiary, Ocean Sihoma, Inc. On July 1, 2022, we amended the Elkurt/Rhode Island License Agreement to extend the
termination date to November 1, 2022, to extend the termination dates of the commercialization plan of the Rhode Island License Agreement
to an additional one year, and acknowledge the accounts payable due and terms of payment. On AugustJuly 26,18, 2022,2024, we amended the Rhode Island
License Agreement to extendeliminate the termination date with respect to Novemberthe 1,equity 2023financing requirement and to extend the termination dates of the commercialization plan
of the Rhode Island License Agreement from an additional onethree yearyears to threefive years.
General
and administrative expenses for the fiscal years ended December 31, 20232024 and 20222023 included stock-based compensation expense related to
the grant by Poseidon, our controlling shareholder, of profits interests in Poseidon to our executives and employees in 2022, the grant
of a warrant to purchase common stock to a consultant in 2023, and stock option grants to all of our non-employee directors as of February
15, 2023, accounting, legal and public relations fees, and deferred offering costs from the Business Combination.
Research
and development expenses for the fiscal year ended December 31, 20232024 decreased by approximately $7.7$0.7 million compared to the fiscal year
ended December 31, 20222023 driven by (i) a decrease ofin stock-basedlicense compensation expensefees of approximately $8.2$0.4 million related to the grant
by Poseidon, our controlling shareholder, of profits interests in Poseidon to our executives and employees in 2021, 60% of the profits
interests granted were immediately vested and the remaining 40% of the profits interests were amortized over 18 months that were 100%
amortized as of August 31, 2022 and (ii) ana increasedecrease in non-employee compensation
and other costs of approximately $0.5$0.3 million for license fees and non-employee compensation.million.
General
and administrative expenses for the fiscal year ended December 31, 20232024 increaseddecreased by approximately $1.8$5.7 million, compared to the fiscal
fiscal year ended December 31, 2022,2023, primarily driven by (i) ana increase in accounting fees of approximately $1.3 million; (ii) an
increasedecrease in legal fees of approximately $1.6$2.8 million; (ii) a decrease in accounting
fees of approximately $0.7 million; (iii) ana increasedecrease in insurance expense of approximately $0.7$0.2 million; (iv) an
increasea decrease in compensation
expense of approximately $1.0 million; and (v) ana increasedecrease in stock-based compensation of approximately $0.5 million; and (vi) a decrease
in outside services of approximately $0.6
million, partially offset by a decrease of stock-based compensation expense of approximately $2.9 million and other expenses of
approximately $0.4$0.5 million.
Other
Income/income (Lossexpense)
Other income (expense) for the fiscal year ended December 31, 2024 decreased by approximately $98.6 million compared to the fiscal year ended December 31, 2023 primarily driven by: (i) a $60.7 million decrease in the changes in fair values of the Fixed Maturity Consideration and Backstop Put Option Liability, (ii) $4.4 million expense related to the change in fair value of the Virion contribution liability and certain charges incurred in the prior year period which are not recurring in 2024, such as (i) $15.1 million related to loss on extinguishment of debt, (ii) $12.7 million related to the share consideration shares issued during the nine months ended September 30, 2023, (iii) $2.3 million related to the issuance of warrants, (iv) $8.4 million in transaction costs, and (v) $0.7 million related to non-cash stock issuances. These decreases were partially offset by (i) $2.6 million related to the change in fair value of the 2023 and 2024 Convertible Notes; (ii) $0.1 million related to the loss on exchange of notes; and(ii) $2.6 million related to our share of the net loss generated by Virion.
Other
income/(Loss) for the fiscal year ended December 31, 2023 increased by approximately $103.0 million compared to the fiscal year
ended December 31, 2022 primarily driven by the costs incurred with respect to the Business Combination and the debt financing,
including: (i) the loss on the Backstop Forward Purchase Agreement asset of approximately $62.6 million; (ii) stock issuance loss of
approximately $12.7 million relating to the fair value of the 1,200,000 Share Consideration Shares issued to the Backstop Parties in
February 2023; (iii) loss on the extinguishment of the debt of approximately $15.1 million resulting from the fair value of the
1,365,000 Sponsor Extension Shares issued to the Sponsor under the terms of the Sponsor Extension Loan and NPIC Extension Loan; (iv)
expense for deferred transaction costs of approximately $7.6 million recognized in the period; (v) fair value of non-cash stock
issuances of approximately $0.7 million; (vii) fair value of warrants issued of approximately $2.3 million and (vii) interest expense of approximately $1.6 million.
Since
our inception, we have incurred significant operating losses. We have not yet commercialized any products and we do not expect to generate
revenue from sales of products for several years, if at all. To date, we have funded our operations from the proceeds from the issuance
of common stock and debt, proceeds from the Backstop Agreement and through self-funding by our founder and have limited current cash
on hand to fund our operations. Based on our current operational plans and assumptions, we expect that the net proceeds from the Ayrton
Convertible Note Financing and future debt and equity financings which total net proceeds we estimate need to be at least $45.0 million,
as well as further deferrals of certain of our accrued expenses and contingency payments due upon the closing of future financings, are
required to fund operations through the fourth quarter of 2025. The Company borrowed an additional $1.7 million in March 2023, the proceeds
of which were used to pay certain accrued expenses. We consummated the closing for the sale of (i) the initial Note in the principal
amount of $7.6 million and (ii) a warrant to initially acquire up to 552,141 additional shares of our Common Stock with an initial exercise
price of $11.50 per share of Common Stock, subject to adjustment, exercisable immediately and expiring five years from the date of issuance
(the “Ayrton Warrant”), which is subject to customary closing conditions, on May 25, 2023.We have up to an additional $7.7
million under the amended Ayrton financing from July 2024. We intend to obtain further equity financing as soon as our financials are
fully current. The Company is currently out of compliance with Nasdaq standards due to its failure to file this report and the 10-Q
reports for the first and second quarters of 2024.
WeAs
of December 31, 2024 and 2023, we also havehad $1.0 million of contingent vendor payments, which are also contingently payable based
only upon our
first cumulative capital raise of at least $50 million.
These
amounts will not be paid if the contingencies do not occur. Since the payment of obligations under these agreements are contingent
upon these future events, which are not considered probable as such future events are deemed outside of our control, we have not
included these amounts in our consolidated financial statements. During the fiscal year ended December 31, 2023, $0.9 million of
contingent compensation was paid and recorded in
general and administrative expenses on the Company’s consolidated statement
of operations. There were no payments of operations.contingent compensation paid during the year ended December 31, 2024.
We
have entered and anticipate we will continue to enter into contracts in the normal course of business with external organizations such
as CMOs, CROs and other third parties for the manufacture of our product candidates and to support clinical trials and preclinical research
studies and testing. We expect that these contracts will be generally cancelable by us, and we anticipate that payments due upon cancellation
will consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers,
up to the date of cancellation. We accrued CMO services in the amount of $0.6$8 thousand and $0.5$0.1 million for the fiscal years ended December 31, 2023
2024 and
2022, 2023, respectively, under the Development and Manufacturing Services Agreement with Lonza in developing the product OCX-253.
To
date, we have not generated any revenue. Cash flows to date have resulted from financing activities, including payments made on behalf
of the Company by related parties and net proceeds from issuance of shares of common stock consisting of friends and family of our employees
and short-term borrowings. As of December 31, 2023,2024, our restricted cash balance of approximately $1.0$0.2 million is held in an escrow account
.account. We do not have any cash equivalents. Cash used in operating activities was used to pay legal and accounting fees. Accounts payable
and accrued expenses of $17.1$16.5 million and $11.9$17.1 million as of December 31, 20232024 and 2022,2023, respectively, were recorded.
What changed in the latest 10-Q
Risk Factors
Removed heading “Because of alternate conversion price notices from our principal noteholder, there may be significant dilution.”
Largest changes
“Because of alternate conversion price notices from our principal noteholder, there may be significant dilution.”see in full comparison
“Between March 4, 2024 and March 8, 2024, our principal noteholder sent Alternate Conversion Notices to the Company to convert the principal value and accrued and unpaid interest under its Note with the Company into shares of Company common stock pursuant to the Alternate Conversion Price mechanism in the Note. The Company is currently evaluating the situation and working with the noteholder to arrive at an equitable resolution. If not resolved, an issuance of shares could result in significant dilution.”see in full comparison
As ofsee in full comparisonSeptemberMarch30,31,2024,2025, we had$15.6$10.5 million in principal of indebtedness outstanding, including$9.7$5.2 million in principal amount of a convertible promissory note issued inJuly20242023.and the first quarter of 2025. We have very limited cash resources from which to repay any obligations that a lender requiresrequiresto be paid in cash. Our level of indebtedness could have important negative consequences to you and us, including:
Full comparison: every changed paragraph (7)
In
addition to those the risk
factors set forth in Part I “Item 1A: Risk Factors” in our Annual Report on Form 10-K for the
year ended December,December 31, 2023, 2024,
and other reports we filed with the SEC, below are certain risk factors related to the Company and its
operations.
As
of SeptemberMarch 30,31, 2024,2025, we had $15.6
$10.5 million in principal of indebtedness outstanding, including $9.7$5.2 million in principal amount of a
convertible promissory note issued
in July2024 2023.and the first quarter of 2025. We have very limited cash resources from which to repay any obligations that a lender requires
requires to be paid in cash. Our level of indebtedness could have important negative consequences to you and us, including:
Our
ability to meet our payment
obligations under our debt instruments depends on our ability to generate significant cash flows or obtain
external financing in the future.
And, in certain cases our debt obligations may be satisfied by way of a conversion into our common
stock, and therefore, our ability to
satisfy certain debt obligations is dependent, in part, on the performance of our common stock.
In each case, to some extent this is subject
to market, economic, financial, competitive, legislative, and regulatory factors as well
as other factors that are beyond our control.
There can be no assurance that our business will generate cash flow from operations, or
that additional capital will be available to us,
in amounts sufficient to enable us to meet our debt payment obligations and to fund
other liquidity needs. Additionally, events and circumstances
may occur which would cause us to not be able to satisfy applicable draw-down
conditions and utilize additional funds under the securities
purchase agreement entered into in May 2023.2023 and amended and restated in July 2024. If we are unable to generate
sufficient cash flows,
or the value of our common stock is insufficient to facilitate conversions of debt obligations as may be necessary
to service our debt
payment obligations, we may need to refinance or restructure our debt, sell assets, reduce or delay capital investments,
or seek to raise
additional capital. If we are unable to implement one or more of these alternatives, we may be unable to meet our debt
payment obligations,
which could have a material adverse effect on our business, results of operations, or financial condition.
Our
ability to make payments
on and to refinance our indebtedness, including our outstanding notes, and to fund intended research and development
efforts will depend
on our ability to generate cash in the future. This, to a certain extent, is subject to general economic, financial,
competitive, legislative,
regulatory and other factors that are beyond our control. We cannot assure you that our business when or if
our operations will ultimately
generate sufficient cash flow from operations, that currently anticipated cost savings and operating improvements
will be realized on
schedule or that future borrowings or another source of liquidity will be available to us u in an amount sufficient
to enable us to pay
our obligations, or to fund our other liquidity needs. If our cash flows and capital resources are insufficient to
fund our debt service
obligations, or we are unable to identify and execute on another source of outside liquidity, we may be forced
to reduce or delay capital
expenditures, sell material assets or operations, attempt to obtain additional equity capital or refinance
all or a portion of our indebtedness,
including the 2023 Convertible Note, on or before maturity. In the absence of such operating results
and resources, we could face substantial
cash flow problems and might be required to sell material assets or operations to meet our debt
service and other obligations. We cannot
assure you as to the timing of such asset sales or the proceeds which we could realize from
such sales and we cannot assure you that we
will be able to refinance any of our indebtedness, including amounts owed under the securities
purchase agreement entered into in May
2023 2023,and amended and restated in July 2024, on commercially reasonable terms or at all.
We
have funded various of our
operations through convertible debt obligations. From time to time we have also issued a number of shares
and warrants to acquire services
and assets from third parties. To the extent that our debt obligations are satisfied by way of conversions
conversions, and we issue additional shares
of our common stock to satisfy obligations or in consideration for assets or services these issuances
would have a dilutive effect on
our existing stockholders.
Because
of alternate conversion price notices from our principal noteholder, there may be significant dilution.
Between
March 4, 2024 and March 8, 2024, our principal noteholder sent Alternate Conversion Notices to the Company to convert the principal value
and accrued and unpaid interest under its Note with the Company into shares of Company common stock pursuant to the Alternate Conversion
Price mechanism in the Note. The Company is currently evaluating the situation and working with the noteholder to arrive at an equitable
resolution. If not resolved, an issuance of shares could result in significant dilution.
Management's Discussion & Analysis (MD&A)
Removed heading “Business Combination Agreement with Aesther Healthcare Acquisition Corp.”
Removed heading “Closing of Business Combination”
Removed heading “Backstop Agreement”
Removed heading “Sponsor Promissory Notes and Ayrton Convertible Note Financing”
Removed heading “Sponsor Promissory Notes”
Removed heading “Equity Financing”
Removed heading “Common Stock Purchase Agreement”
Largest changes
“The Notes provide for certain events of default, including, among other things, any breach of the covenants described in the SPA and any failure of Dr. Chirinjeev Kathuria to be the chairman of our Board of Directors. In connection with an event of default, the noteholders may require us to redeem all or any portion of the Notes, at a premium set forth in the SPA.”see in full comparison
“On May 23, 2023 we received an Equity Prepaid Forward Transaction - Valuation Date Notice (“Notice”) from Vellar stating that, due to our alleged failure to timely register the shares held by Vellar, Vellar has the right to terminate the Backstop Agreement as to their portion of the shares and Vellar is claiming it is entitled to receive Maturity Consideration (as defined in the Backstop Agreement) equal to $6.7 million, which at our discretion may be paid in cash or by offset to the shares currently held by Vellar. …”see in full comparison
“Business Combination Agreement with Aesther Healthcare Acquisition Corp.”see in full comparison
“Sponsor Promissory Notes and Ayrton Convertible Note Financing”see in full comparison
“We are subject to certain customary affirmative and negative covenants regarding the rank of the Notes, the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters. …”see in full comparison
“In May 2023, we consummated the closing for the sale of (i) the initial Note in the principal amount of $7.6 million and (ii) a warrant to initially acquire up to 552,141 additional shares of our common stock with an initial exercise price of $11.50 per share of common stock, subject to adjustment, exercisable immediately and expiring five years from the date of issuance (the “SPA Warrant”). Each Note will be sold at an original issue discount of 8%. Future issuances of Notes (“Additional Closings”) are subject to satisfaction of certain conditions. …”see in full comparison
Full comparison: every changed paragraph (67)
You
should read the following discussion and analysis of our financial condition and results of operations together with Ocean Biomedical,
Inc.’s (the “Company,” “Ocean Biomedical,” “we,” “us” and “our”) condensed
consolidated financial statements and related notes included elsewhere in this Report and the audited consolidated financial statements
and related notes thereto included in Exhibit 99.2 our Amendment No. 2 to Form 8-K10-K filed with the SEC on MarchApril 31,8, 2023.2025. The information
contained in this discussion
and other parts of this Report include forward-looking statements that involve risks, uncertainties, and
assumptions in our business plans,
strategy, and related financing. Our actual results could differ materially from the results discussed
in or implied by these forward-looking
statements. Factors that could contribute or cause such differences include, but are not limited
to, the information below and the information
discussed in the section titled “Cautionary Note Regarding Forward-looking Statements.”
On
February 14, 2023, we consummated a business combination (the “Business Combination”) pursuant to that certain Agreement
and Plan of Merger, dated August 31, 2022, as amended on December 5, 2022 by Amendment No. 1 (as amended, the “Business Combination
Agreement”), by and among Ocean Biomedical, Inc., formerly known as Aesther Healthcare Acquisition Corp. (the “Company”),
AHAC Merger Sub, Inc., a Delaware corporation, Aesther Healthcare Sponsor, LLC (the “Sponsor”), in its capacity as purchaser
representative, Ocean Biomedical Holdings, Inc., formerly known as Ocean Biomedical, Inc., a Delaware corporation (“Legacy Ocean”),
and Dr. Chirinjeev Kathuria, in his capacity as seller representative. In connection with the closing of the Business Combination (the
“Closing”), the Company changed its name from “Aesther Healthcare Acquisition Corp.” to “Ocean Biomedical,
Inc.” References to the “Company”, “Ocean Biomedical”, “we”, “us” and “our”
refer to the Legacy Ocean prior to the Closing of the Business Combination and Ocean Biomedical, Inc., formerly known as Aesther Healthcare
Corp., on a consolidated basis with Legacy Ocean, for periods after the Closing of the Business Combination.
Our
goal is to optimize value
creation for each of our product candidates, and we intend to continuously assess the best pathway for each
as it progresses through the
preclinical and clinical development process—including through internal advancement, partnerships
with established companies and spin-outs
spinouts or other strategic transactions—in order to benefit patients through the commercialization
of these products. Our current
active assets are licensed from Brown University and Rhode Island Hospital. Our scientific co-founders
and members of our Board of Directors
(“Board”), Dr. Jack A. Elias and Dr. Jonathan Kurtis, are both affiliated with Brown
University and with Rhode Island Hospital.
Our strategy is to accelerate the flow of the academic discoveriesdiscoveries, and the required clinical
development required for these product candidates
and advance them commercially. The number of potential opportunities at research universities
and medical centers is large, but only a
small fraction of these opportunities is currently tapped in the market. The gap remains wide
wide, and we believe this presents an attractive
opportunity for us to become an industry leader by addressing a need to accelerate the advancement
of therapeutics that can address significant
unmet medical needs. The core elements that we believe differentiate our business model
include:
We
have incurred significant
operating losses since inception. Our ability to generate product revenues sufficient to achieve profitability
will depend heavily upon
the successful development and eventual commercialization of one or more of our current products or any future
products. Our net losses
were $5.5 million and $14.1$8.2 million for the three months ended SeptemberMarch 30,31, 20242025. andWe 2023,reflected respectively,net and
$9.8income millionof and $97.6$13.0 million for the ninethree months ended SeptemberMarch
31, 30,2024, 2024primarily due to a gain recognized in connection with the Backstop Put Option Liability and 2023,Fixed respectively.Maturity Consideration. As
of SeptemberMarch 30,31, 20242025 and December
31, 2023,2024, we had a stockholders’ deficit of $98.1$92.4 million and $90.8$97.6 million, respectively. Our current
liabilities are $33.6$26.6 million
and $30.0$33.9 million as of SeptemberMarch 30,31, 20242025 and December 31, 2023,2024, respectively. Our current liabilities consisted
of accrued expenses
including transaction costs, accounting and legal fees, accrued research and development costs, and short-term loans.
We expect that
our expense and capital requirements will increase substantially in connection with ongoing activities to commercialize
our products
in the future.
Business
Combination Agreement with Aesther Healthcare Acquisition Corp.
Closing
of Business Combination
On
February 14, 2023, we consummated our previously announced Business Combination pursuant to the Business Combination Agreement, at which
time AHAC Merger Sub Inc., a wholly-owned subsidiary of AHAC, merged with and into Legacy Ocean, with Legacy Ocean surviving the merger
as a wholly-owned subsidiary of the Company. In connection with the Closing, the Company changed its name from “Aesther Healthcare
Acquisition Corp.” to “Ocean Biomedical, Inc.”
In
connection with the Closing (or immediately prior to, where indicated), among other things:
The
Business Combination is accounted for as a reverse capitalization in accordance with U.S. GAAP. Under the guidance in ASC 805, Business
Combinations, AHAC is treated as the “acquired” company for financial reporting purposes. See Note 3, Business Combination
and Backstop Agreement, of our condensed consolidated financial statements included elsewhere in this Report for additional detail
about the Business Combination and related transactions. The Liquidity and Capital Resources section below also includes further
discussion of these transactions.
As
a result of becoming a public company, we have begun, and will continue to need to hire additional staff and implement processes and
procedures to address public company regulatory requirements and customary practices. We incurred and expect to continue to incur additional
annual expenses for, among other things, directors’ and officers’ liability insurance, director fees and additional internal
and external accounting, legal and administrative resources and fees.
We
recognize external development
costs based on an evaluation of the progress to completion of specific milestones using information provided
to us by our service providers.
This process involves reviewing open contracts and purchase orders, communicating with our personnel
to identify services that have been
performed on our behalf and estimating the level of service performed and the associated cost incurred
for the service when we have not
yet been invoiced or otherwise notified of actual costs. Such amounts are expensed as the related goods
are delivered or the related services
are performed, or until it is no longer expected that the goods will be delivereddelivered, or the services
rendered.
Our direct external research and development expenses consist of (or are expected to consist) primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and research laboratories in connection with our preclinical development, process development, manufacturing and clinical development activities. Our direct research and development expenses also include fees incurred under license agreements. We have not allocated and do not expect to allocate employee costs, costs associated with our discovery efforts, laboratory supplies, and facilities, including depreciation or other indirect costs, to specific programs because these costs are or will be deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to conduct our research and discovery as well as for managing our preclinical development, process development, manufacturing and clinical development activities. These employees work across multiple programs and, therefore, we do not track their costs by program.
Comparison
of the Three
months Ended March 31, 2025 and Nine months ended September 30, 2024 and 2023
Research
and development expense
for the three months ended SeptemberMarch 30,31, 20242025 decreasedwere bybasically $0.3 million,unchanged, as compared to the three months ended
September 30,March 2023.31, 2024.
Research
and development expense for the nine months ended September 30, 2024 decreased by $0.7 million, as compared to the nine months ended
September 30, 2023.
General
and administrative expense
for the three months ended SeptemberMarch 30,31, 20242025 decreasedincreased by $1.6$0.4 million, as compared to the three months ended
September 30,March 2023.31, 2024. The $1.6$0.4 million decrease
increase was primarily driven by decreasesincreases in the costs associated with our year-end audit and the filing of (i)our $0.7Form million10-K, since those
services were not completed in professionalthe services,prior (ii)year $0.6
million in salaries and wages, and (iii) $0.3 million in insurance and public relations.period.
General
and administrative expenses for the nine months ended September 30, 2024 decreased by $8.1 million, as compared to the nine months ended
September 30, 2023. The decrease of $8.1 million was primarily driven by decreases of (i) $5.5 million in professional services, (ii)
$1.0 million in salaries and wages, (iii) $0.5 million in stock-based compensation, and (iv) $1.0 million in insurance and public relations.
Other expense for the three
months ended SeptemberMarch 30,31, 20242025 decreasedincreased by
$6.7 $20.9 million, as compared to the three months ended SeptemberMarch 30,31, 2023.2024. The decreaseincrease of $6.7$20.9 million
was primarily driven by (i) a $9.8$18.1 million
decrease in the changes in fair values of the Fixed Maturity Consideration and Backstop Put
Option Liability,Liability; (ii) $2.7 million increase in transaction costs; and (iii) $1.7 million of redemption premium on debt conversions,
partially offset by (i)
$0.6a $1.3 million related to loss on issuance of put options; (ii) $0.2 million expense related to the change in fair value of the Virion2024 contribution
liability,Convertible (iii) the net loss attributable to equity interest in Virion of $0.5 millionNotes and (iv)SPA $1.8 million related to the loss on exchange
of notes.warrants.
Other
expense for the nine months ended September 30, 2024 decreased by $79.0 million, as compared to the nine months ended September 30, 2023.
The decrease of $79.0 million was primarily driven by (i) a $45.8 million decrease in the changes in fair values of the Fixed Maturity
Consideration and Backstop Put Option Liability, (ii) $0.2 million expense related to the change in fair value of the Virion contribution
liability and certain charges incurred in the prior year period which are not recurring in the nine months ended September 30, 2024,
such as (i) $13.6 million related to loss on extinguishment of debt, (ii) $12.7 million related to the share consideration shares issued
during the nine months ended September 30, 2023, (iii) $1.9 million related to the issuance of warrants, (iv) $8.0 million in transaction
costs, and (v) $2.2 million related to non-cash stock issuances. These decreases were partially offset by (i) $1.8 million related
to the loss on exchange of notes; and(ii) $3.3 million related to our share of the net loss generated by Virion.
Since
our inception, we have
incurred significant operating losses. We have not yet commercialized any products and we do not expect to generate
revenue from sales
of products for several years, if at all. We had no cash inflows from operating activities for the ninethree months ended March 31, 2025.
September 30, 2024. Further, as of SeptemberMarch 30,31, 2024,2025, we had minimalno cash and a working capital deficiency of $32.6$23.1 million.
To
date, we have funded our operations
from the proceeds from the issuance of common stock and debt, proceeds from the Backstop Agreement
and through self-funding by our founder
and have limited current cash on hand to fund our operations. Based on our current operational
plans and assumptions, we expect that the
net proceeds from the Backstop Agreement, the Ayrton Convertible Note Financing and future
debt and equity financings, including possibly under the Common Stock Purchase Agreement, as well as further
deferrals of certain of
our accrued expenses and contingency payments due upon the closing of future financings, are required to fund
operations into the third
quarter of 2024.2025. As of SeptemberMarch 30,31, 20242025, we received $1.4 million in cumulative proceeds from the Backstop Agreement.
We borrowed $3.7 million in the second half of 2024 and $1.0 million in the first quarter of 2025 from additional tranches under the Ayrton Convertible Note Financing, the proceeds of which were used to fund working capital requirements. As of March 31, 2025, the principal of our remaining short-term loans outstanding was $10.1 million.
We
borrowed $13.5 million in the first half of 2023, including the proceeds from the initial Note under the Ayrton Convertible Note
Financing, the proceeds of which were used to pay the related-party loans and certain accrued expenses. We consummated the closing
of the sale of the initial Note on May 25, 2023 for approximately $6.1 million, net of expenses and issuance costs, which we used to
pay the remainder of our existing related-party loans and a portion of our existing short-term loans, totaling $1.6 million. In July
2024, we borrowed $1.0 million under the new 2024 Convertible Note. As of September 30, 2024, the principal of our remaining
short-term loans outstanding was $15.6 million.
There
is an economic disincentive for the Backstop Parties to sell shares of our common stock that are subject to the restrictions set forth
in the Backstop Agreement unless our common stock is trading above $10.34 per share (as it relates to certain of the Backstop Parties)
or $8.00 per share (as it relates to one of the Backstop Parties), which means that we need to assume that no cash will be returned to
us pursuant to any sales under the Backstop Agreement unless our common stock is trading above $8.00 and one or more of our Backstop
Parties are otherwise able to sell their shares. Based upon the level of funding that we receive from the foregoing sources, we will
determine the amount of accrued expenses and contingency payments that we will seek to have our vendors further defer and how much we
are able to spend on our operations. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our
available capital resources sooner than we expect, in which case, we would need to raise more capital and sooner than expected. We cannot
guarantee that we will be able to draw down additional loans under the Ayrton Convertible Note Financing or raise additional capital
on reasonable terms or at all, that our common stock will trade above $8.00, permitting one of the Backstop Parties to sell shares under
the Backstop Agreement, that our common stock will trade above $10.34, permitting the other Backstop Parties to sell shares under the
Backstop Agreement, that the Backstop Parties will sell any shares of our common stock held by them or elect to terminate the Backstop
Agreement in respect of those shares, or that our vendors will agree to further deferrals of payments due to them. Although the Common
Stock Purchase Agreement provides that we have the right, but not the obligation to require White Lion to purchase, from time to time,
up to $75.0 million in aggregate gross purchase price of Equity Line Shares, we are not required or permitted to issue any shares of
our common stock under the Common Stock Purchase Agreement if such sale would result in White Lion owning more than 9.99% of our outstanding
shares of common stock.
Effective
October 4, 2023, the Company and White Lion entered into the first amendment of the Common Stock Purchase Agreement (the “Amendment”).
The Amendment is intended to afford the Company greater flexibility and provide the Company an additional alternative to issue a fixed
price “Purchase Notice” under the Common Stock Purchase Agreement at $7.00 per share if the market price for the Common Stock
exceeds $9.00 per share. In addition, on November 2, 2023, White Lion purchased 41,677 shares of the Company’s common stock under
the Common Stock Purchase Agreement for which the Company received approximately $64 thousand. This facility is now deemed terminated.
Backstop
Agreement
As
discussed above, prior to Closing, on February 12, 2023, AHAC, Legacy Ocean and Vellar entered into an amended and restated OTC Equity
Prepaid Forward Transaction, referred to herein as the Backstop Agreement. Concurrently, on February 13, 2023, AHAC, Vellar and Legacy
Ocean entered into separate assignment and novation agreements (as amended as it relates to Polar on October 2, 2023), whereby Vellar
assigned its rights and obligations to a portion of the shares of Class A common stock subject to the Backstop Agreement to Meteora and
Polar. Further, the Backstop Agreement granted the Backstop Parties the right to purchase Additional Shares from us of up to an amount
equal to the difference between the number of Recycled Shares and the maximum number of shares of 8,000,000.
On
February 14, 2023, pursuant to the Backstop Agreement, (i) the Backstop Parties purchased 3,535,466 Recycles Shares of AHAC’s Class
A common stock for $10.56 per share and (ii) pursuant to Polar’s exercise of its right to purchase Additional Shares, AHAC, Legacy
Ocean and Polar entered into a subscription agreement pursuant to which Polar purchased 1,350,000 newly issued shares of our common stock
at a per share purchase price of approximately $10.56 (the “Polar Subscription”). Under the Backstop Agreement, the Additional
Shares are subject to the same terms as the Recycled Shares, including with regard to repayment and repurchase.
We
agreed to purchase those shares from the Backstop Parties on a forward basis upon the “Maturity Date” (as amended, the third
anniversary of the closing of the Business Combination, subject to certain acceleration provisions). The purchase price payable by us
includes a prepayment in the amount of the redemption price per share (the “Prepayment”).
Subsequent
to Closing, the Prepayment amount was equal to $51.6 million, consisting of $37.3 million for the Recycled Shares and $14.3 million for
the Polar Subscription shares. As the $14.3 million was a netted transaction between us and Polar, only $37.3 million was paid out of
the funds we received from AHAC’s trust account. This net impact from the payment outflow to Backstop Parties for the Backstop
Agreement of $51.6 million and the proceeds inflow from the issuance of common stock pursuant to the Backstop Agreement and Polar Subscription
of $14.3 million are reported in our condensed consolidated statement of cash flows.
At
any time prior to the Maturity Date, the Backstop Parties may elect an optional early termination to sell some or all of the Recycled
Shares in the open market. If the Backstop Parties sell any shares prior to the Maturity Date, the pro-rata portion of the Prepayment
is due back to us. As of September 30, 2024, the Backstop Parties have sold 143,261 shares, for which we received net proceeds of $1.4
million, after paying related fees to the Backstop Parties. Depending on the manner in which the OTC Equity Prepaid Forward Transaction
is settled, we may never have access to the full Prepayment.
On
May 23, 2023 we received an Equity Prepaid Forward Transaction - Valuation Date Notice (“Notice”) from Vellar stating that,
due to our alleged failure to timely register the shares held by Vellar, Vellar has the right to terminate the Backstop Agreement as
to their portion of the shares and Vellar is claiming it is entitled to receive Maturity Consideration (as defined in the Backstop Agreement)
equal to $6.7 million, which at our discretion may be paid in cash or by offset to the shares currently held by Vellar. Management takes
issue with multiple aspects of the Notice including, but not limited to, Vellar’s right to terminate their portion of the Backstop
Agreement and their asserted Maturity Consideration calculation. As such, we are consulting with advisors and other parties and are considering
the potential resources and remedies we may elect to pursue, and intend to assert our rights should this matter not be resolved. After
a review of all applicable documents related to the Backstop Agreement, we believe our position with respect to the terms of the agreement
and intent of the parties is supported by the Backstop Agreement and the facts and circumstances under which it was entered into. Further,
given the early stage of this matter and the uncertainty inherent in litigation and investigations, the Company does not currently believe
it is (i) probable to incur losses or (ii) possible to develop estimates of reasonably possible losses (or a range of possible losses)
for this matter.
Refer
to Note 3, Business Combination and Backstop Agreement, in our condensed consolidated financial Statements included elsewhere
in this Report for further detail on the Backstop Agreement and Note 4, Fair Value Measurements, for further detail around the
valuation of the Fixed Maturity Consideration and Backstop Put Option Liability.
Sponsor
Promissory Notes and Ayrton Convertible Note Financing
Sponsor
Promissory Notes
Upon
consummation of the Business Consummation, we assumed two of AHAC’s loans, totaling $2.1 million, one of which accrued interest
at 8% per annum and the other accrues interest at 15% per annum. Both were due within five days of Closing. $0.5 million was paid down
at Closing, with the remaining paid down in May 2023 via the proceeds received from the initial Note under the Ayrton Convertible Note
Financing, discussed below.
In
connection with the assumption of AHAC’s loans and pursuant to the terms of the Business Combination Agreement described above,
we issued 1,365,000 shares of our common stock to the Sponsor as consideration for providing the loans to us (the “Sponsor Extension
Shares”). In addition, pursuant to the terms of an amendment entered into prior to the paydown of the loans, we issued a total
of 200,000 shares of our common stock in exchange for extension of the maturity date of one of the loans.
We
recognized a loss on extinguishment of debt of $1.2 million in our consolidated statements of operations for the nine months ended September
30, 2023 for the 200,000 shares issued in exchange for extensions of the maturity date, based on the grant date fair value of the shares
issued. In addition, we recognized a loss on extinguishment of debt of $13.6 million in our condensed consolidated statements of operations
for the nine months ended September 30, 2023 for the issuance of the Sponsor Extension Shares, based on the grant date fair value. Further,
we recorded interest expense of $18 thousand and $36 thousand in our condensed consolidated statements of operations for the three and
nine months ended September 30, 2023, respectively.
Refer to Note 7, Senior Secured Convertible Notes, in Part I, Item 1. “Financial Statements” for additional detail about our convertible notes and the warrants issued in conjunction with these loans.
In
May 2023, we entered into a Securities Purchase Agreement (the “SPA”) with an accredited investor (the “Investor”)
for the sale of up to three Senior Secured Convertible Notes (each, a “Note” and collectively, the “Notes”),
which Notes are convertible into shares of our common stock, in an aggregate principal amount of up to $27.0 million, in a private placement
(the “Ayrton Convertible Note Financing”).
In
May 2023, we consummated the closing for the sale of (i) the initial Note in the principal amount of $7.6 million and (ii) a warrant
to initially acquire up to 552,141 additional shares of our common stock with an initial exercise price of $11.50 per share of common
stock, subject to adjustment, exercisable immediately and expiring five years from the date of issuance (the “SPA Warrant”).
Each Note will be sold at an original issue discount of 8%. Future issuances of Notes (“Additional Closings”) are subject
to satisfaction of certain conditions. At the closing of the first Additional Closing, $8.64 million in principal amount of Notes will
be issued and $10.8 million in principal amount of Notes will be issued at the closing of the second Additional Closing. So long as any
Notes remain outstanding, we and each of our subsidiaries are prohibited from effecting or entering into an agreement to effect any subsequent
placement involving a Variable Rate Transaction, as defined within the SPA, other than pursuant to the White Lion Common Stock Purchase
Agreement.
We
were required to obtain stockholder approval authorizing the issuance of our common stock under the Notes and Warrant in compliance with
the rules and regulations of the Nasdaq (without regard to any limitations on conversion or exercise set forth in the Notes or Warrant,
respectively), including, shares of our common stock to be issued in connection with any Additional Closing. We obtained stockholder
approval of the transaction in August 2023 at a special meeting of stockholders. As a result, there is no limitation under the SPA that
would prohibit us from issuing to the investor shares of common stock in excess of 19.99% of our outstanding shares of common stock as
of the date of the SPA.
The
interest rate applicable to each Note is, as of any date of determination, the lesser of (i) 8% per annum and (ii) the greater of (x)
5% per annum and (y) the sum of (a) the “secured overnight financing rate,” which from time to time is published in the “Money
Rates” column of The Wall Street Journal (Eastern Edition, New York Metro), in effect as of such date of determination and (b)
2% per annum. Each Note will mature on the first anniversary of its issuance. Additionally, each Note is required to be senior to all
of our other indebtedness, other than certain permitted indebtedness. The Notes will be secured by all of our existing and future assets
(including those of our significant subsidiaries). Upon the occurrence of certain events, the Notes will be payable in monthly installments.
A noteholder may, at its election, defer the payment of all or any portion of the installment amount due on any installment date to another
installment payment date.
All
or any portion of the principal amount of each Note, plus accrued and unpaid interest is convertible at any time, in whole or in part,
at the noteholder’s option, into shares of our common stock at an initial fixed conversion price of $10.34 per share, subject to
certain adjustments and alternative conditions. A noteholder will not have the right to convert any portion of a Note, to the extent
that, after giving effect to such conversion, the noteholder (together with certain of its affiliates and other related parties) would
beneficially own in excess of 9.99% of the shares of our common stock outstanding immediately after giving effect to such conversion.
Upon a change of control, noteholders may require us to redeem all, or any portion, of the Notes at a price stipulated by certain conditions
as discussed within the SPA.
The
Notes provide for certain events of default, including, among other things, any breach of the covenants described in the SPA and any
failure of Dr. Chirinjeev Kathuria to be the chairman of our Board of Directors. In connection with an event of default, the noteholders
may require us to redeem all or any portion of the Notes, at a premium set forth in the SPA.
We
are subject to certain customary affirmative and negative covenants regarding the rank of the Notes, the incurrence of indebtedness,
the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions
or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters.
We are also subject to financial covenants requiring that (i) the amount of our available cash equal or exceed $3.0 million at the time
of each Additional Closing; (ii) the ratio of (a) the outstanding principal amount of the Notes, accrued and unpaid interest thereon
and accrued and unpaid late charges to (b) our average market capitalization over the prior ten trading days, not exceed 35%; and (iii)
at any time any Notes remain outstanding, with respect to any given calendar month (each, a “Current Calendar Month”) (x)
the available cash on the last calendar day in such Current Calendar Month shall be greater than or equal to the available cash on the
last calendar day of the month prior to such Current Calendar Month less $1.5 million.
Equity
Financing
Common
Stock Purchase Agreement
Following
the Business Combination, we are subject to the terms and conditions of (i) a common stock purchase agreement, dated September 7, 2022,
and as amended on October 4, 2023, (the “Common Stock Purchase Agreement”) and (ii) a registration rights agreement, dated
September 7, 2022 (the “White Lion Registration Rights Agreement”), that AHAC entered into with White Lion Capital LLC (“White
Lion”). Pursuant to the Common Stock Purchase Agreement, we have the right from time to time at its option to sell to White Lion
up to $75.0 million in aggregate gross purchase price of newly issued shares (“Equity Line Shares”) of our common stock,
subject to certain limitations and conditions set forth in the Common Stock Purchase Agreement. These limitations stipulate, among other
things, that we may not sell, and White Lion may not purchase, shares of our common stock that would result in White Lion owning more
than 9.99% of our outstanding common stock. The Common Stock Purchase Agreement expires after two years.
In
consideration for the commitments of White Lion to purchase Equity Line Shares, the Common Stock Purchase Agreement included issuing
initial commitment shares with a value of $0.8 million based upon the closing sale price two days prior to the filing of the initial
registration statement.
In
April 2023, the Common Stock Purchase Agreement was amended to fix the number of initial commitment shares at 75,000 shares to White
Lion, which had a fair value of $0.5 million upon issuance. The $0.5 million in commitment costs were recorded in other income (expense)
in our condensed consolidated statements of operations.
Effective
October 4, 2023, the Company and White Lion entered into the first amendment of the Common Stock Purchase Agreement (the “Amendment”).
The Amendment is intended to afford the Company greater flexibility and provide the Company an additional alternative to issue a fixed
price “Purchase Notice” under the Common Stock Purchase Agreement [at $7.00 per share if the market price for the Common
Stock exceeds $9.00 per share]. In addition, on November 2, 2023, White Lion purchased 41,677 shares of the Company’s common stock
under the Common Stock Purchase Agreement for which the Company received approximately $64 thousand. This facility is now deemed terminated.
Any
future proceeds earned from the sale of shares will be used to support funding of our ongoing operations and working capital.
Our
contractual obligations are
expected to have an effect on our liquidity and cash flows in future periods. Under our license agreements
with our academic research
institution partners, fixed license maintenance fees of $0.3 million are due within 15 days of financing of
at least $10.0 million and
$0.1 million are due within 30 days of financing of at least $10.0 million. In addition, under these license
agreements, we are also required
to make payments upon successful completion and achievement of certain milestones as well as royalty
payments upon sales of products covered
by such licenses. The payment obligations under the license fees are recorded in accounts payable.
The payment obligations under the collaboration
agreements are contingent upon future events such as our achievement of specified development,
clinical, regulatory, and commercial milestones.
As the timing of these future milestone payments are not known, we have not included
these fees in our condensed consolidated balance
sheets as of SeptemberMarch 30,31, 2024.2025. None of these were paid as of SeptemberMarch 30,31, 2024.2025.
Under
the management employment
agreements, we have salaries and bonuses that are contingently payable upon financing, collectively called
contingent compensation, that
are contingently payable based only upon our first cumulative capital raise of at least $50.0 million.
As of SeptemberMarch 30,31, 2024,2025, we have contingent
compensation and bonuses in the amount of $14.8$16.9 million to certain members of senior management
as well as $1.0 million in contingent
vendor payments. These amounts will not be paid if the contingencies do not occur. Since the payment
of obligations under the employment
agreements are contingent upon these future events, which are not considered probable as such future
events are deemed outside of our
control, we have not included these amounts in our condensed consolidated financial statements. None
of these were paid as of SeptemberMarch 30, 2024.31,
2025.
We
have entered and anticipate
we will continue to enter into contracts in the normal course of business with external organizations such
as CMOs, CROs and other third
parties for the manufacture of our product candidates and to support clinical trials and preclinical research
studies and testing. We
expect that these contracts will be generally cancelable by us, and we anticipate that payments due upon cancellation
will consist only
of payments for services provided or expenses incurred, including noncancelable obligations of our service providers,
up to the date of
cancellation. We accrued CMO services in the amount of $0.6 million for the three and nine months ended September 30,
2024 and 2022 under the Development and Manufacturing Services Agreement with Lonza in developing the product OCX-253.
To
date, we have not generated
any revenue. Cash flows to date have resulted from financing activities, including payments made on behalf
of the Company by related parties
and net proceeds from issuance of shares of common stock consisting of friends and family of our employees
and short-term borrowings,
including the initial Note from the Ayrton Convertible Note Financing. As of SeptemberMarch 30,31, 2024, our unrestricted
cash balance was minimal and2025, our restricted cash balance of $0.2$0.8 million is held in an escrow account. We do not have
any cash equivalents.
Cash used in operating activities was primarily used to pay legal and accounting fees. Our outstanding accounts
payable and accrued expenses
of $16.6$17.0 million as of SeptemberMarch 30,31, 20242025, willare expected to be paid off utilizing future proceeds from current and future
financings, including proceeds
from additional closings under the 2024 Convertible Note and future debt and equity financings.
Our consolidated
consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States of America, or
orU.S. GAAP. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and
judgments judgments
that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates on historical
experience, known trends
and events, and various other factors that we believe are reasonable under the circumstances, the results
of which form the basis for
making judgments about the carrying values of assets and liabilities that are not readily apparent from
other sources. We evaluate our
estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates
under different assumptions or conditions.
While our significant accounting policies are described in more detail in Note 2, Summary
of Significant Accounting Policies,
to our condensed consolidated financial statements appearing elsewhere in this Report, we
believe that the following accounting policies
are those most critical to the judgments and estimates used in the preparation of our
consolidated financial statements.
We utilized
utilized a Monte-Carlo simulation to value the Backstop Put Option Liability and Fixed Maturity Consideration. The key inputs and assumptions used
used in the Monte-Carlo Simulation, including volatility, expected term, expected future stock price, and various simulated paths, were utilized
utilized to estimate the fair value of the associated derivative liabilities. The value of the Backstop Put Option Liability and Fixed Maturity
Maturity were calculated as the average present value over 50,000 simulated paths. We measure the fair value at each reporting period,
with subsequent
of fair values to be recorded within other income (expense) in our condensed consolidated statements of operations.
Valuation
of 20232024 Convertible
Note and SPA WarrantWarrants
OCEA insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding OCEA (13F)
None of the 59 investors we track reported a position in their latest 13F.