What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2022-11-10 compared with 2022-08-10 · 87 added, 73 removed, 227 unchanged (41% of the section changed)

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As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

We aim to improve patient outcomes by advancing a pipeline of product candidates designed to benefit large populations of patients with cancer and other diseases, developed using our translational bioinformatics platform.

We aim to create medicines for all patients with solid tumors driven by RAS mutations and other MAPK pathway activation events .

We have more than a decade of experience applying translational bioinformatics to generate insights into drug mechanism of action and patient treatment response.

Building on this experience, our disease-agnostic discovery platform enables us to create product candidates based on 1) biological insights that are both counterintuitive and deeply rooted in data, and 2) novel chemistry.

Our lead product candidate IMM-1-104 aims to achieve pan-KRAS/NRAS activity that selectively impacts cancer cells to a greater extent than healthy cells.

IMM 1-104 is designed to be a highly selective dual-MEK inhibitor that further disrupts KSR to modulate the signaling dynamics of the MAPK pathway by driving deep cyclic inhibition that deprives tumor cells of the sustained proliferative signaling required for rapid growth, while providing a cadenced, moderate level of signaling sufficient to spare healthy cells.

IMM-1-104 is being developed to treat advanced solid tumors in patients harboring RAS mutations, and is translationally guided by our proprietary, human-aligned 3D tumor modeling platform combined with patient-aligned bioinformatics.

In addition to IMM-1-104, we are evaluating our MEK-io product candidate, IMM-6-415, in IND enabling studies, and we have five other oncology programs in the discovery stage that are designed to target components of the MAPK or mTOR pathway, as well as two discovery stage neuroscience programs.

We plan to submit an IND, for IMM-1-104 to the U.S.

Food and Drug Administration, or the FDA, in the third quarter of 2022.

In addition, we plan to submit an IND for IMM-6-415 to the FDA in 2023.

We anticipate filing at least one additional IND for our other oncology programs in 2024.

Building on this experience, our disease-agnostic discovery platform enables the company to create product candidates based on 1) biological insights that are both counterintuitive and deeply rooted in data, and 2) novel chemistry.

Our lead product candidate, IMM-1-104, aims to achieve pan-RAS activity that selectively impacts cancer cells to a greater extent than healthy cells.

IMM-1-104 is designed to be a highly selective third generation dual MEK inhibitor that modulates the signaling dynamics of the MAPK pathway by driving deep cyclic inhibition that deprives tumor cells of the sustained proliferative signaling required for rapid growth, while providing a cadenced, normalized level of signaling designed to spare healthy cells.

IMM-1-104 is being developed to treat advanced solid tumors in patients harboring RAS mutations, and is translationally guided by Immuneering's proprietary, human-aligned 3D tumor modeling platform combined with patient-aligned bioinformatics.

In addition to IMM-1-104, we are currently evaluating IMM-6-415 in IND-enabling studies.

Our earlier drug discovery pipeline includes five additional oncology programs as well as two neuroscience programs.

On September 30, 2022, the U.S.

Food and Drug Administration allowed our Phase 1/2a clinical trial of IMM-1-104 for the treatment of advanced RAS mutant solid tumors to proceed.

We are currently recruiting for the trial and we plan to dose the first patient in the trial in the fourth quarter of 2022.

The Phase 1/2a clinical trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of IMM-1-104.

The Phase 1 portion of the clinical trial will evaluate IMM-1-104 in order to establish a recommended Phase 2 dose in solid tumor patients with evidence of any RAS mutation.

The Phase 2a portion will evaluate dose expansion of IMM-1-104 in patients with certain RAS mutated cancers, including pancreatic, melanoma, colorectal and lung.

In addition, we plan to submit an Investigational New Drug Application (“IND”) for IMM-6-415 to the FDA in the fourth quarter of 2023.

We anticipate submitting at least one additional IND for our other oncology programs in 2024.

For the period from inception through 2017, we devoted substantially all of our efforts to business planning, service revenue generation, developing tools to aid in drug discovery, and recruiting management and technical staff.

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BioArkive was fully integrated into our operations and exclusively supports our internal preclinical research activities for our oncology pipeline.

In connection with the acquisition, we have assumed the obligations under BioArkive’s three lease agreements.

In connection with the acquisition, we assumed the obligations under BioArkive’s three lease agreements.

The purchase price was paid by us through the issuance of an aggregate of 379,635 shares of our Class A common stock.

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Since inception, we have had significant annual operating losses.

Our net loss was approximately $24.4 million, for the six months ended June 30, 2022 and $33.5 million for the year ended December 31, 2021.

As of June 30, 2022, we had an accumulated deficit of approximately $83.7 million and approximately $128.1 million in cash and cash equivalents and marketable securities.

Our net loss was approximately $37.3 million, for the nine months ended September 30, 2022 and $33.5 million for the year ended December 31, 2021.

As of September 30, 2022, we had an accumulated deficit of approximately $96.5 million and approximately $117.2 million in cash and cash equivalents and marketable securities.

Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses.

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If we obtain regulatory approval for any of our internally developed product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.

As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through service revenue, equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements.

As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements.

However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all.

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In March 2020, the World Health Organization declared the coronavirus (“COVID-19”) outbreak a pandemic and we continue to monitor the ongoing impacts of the COVID-19 pandemic.

We cannot presently predict the scope and severity of any future potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage, including personnel at third-party manufacturing facilities and other third parties with whom we conduct business, were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timeline presently planned could be materially and adversely impacted.

presently planned could be materially and adversely impacted.

While to date we have been able to continue to execute our overall business plan, it is unknown how long these conditions will last and what the complete effect will be on us.

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We expect revenue to continue to decrease as we have deprioritized new services work in order to focus on developing our wholly owned pipeline.

We expect that, by the end of 2022, revenue associated with this computational biology professional services business will be eliminated.

We are in the process of discontinuing biosample storage, which was acquired through the BioArkive transaction, to external parties and expect it to complete in the second half of 2022.

In September 2022, we completed our last remaining services contract associated with the computational biology professional services business.

At this time, we do not anticipate entering into any new service contracts or agreements.

We are in the process of discontinuing biosample storage, which was acquired through the BioArkive transaction, to external parties and expect it to complete by the end of 2022.

The revenue earned associated with this is immaterial to the financial statements and is expected to continue to decrease until these external services are discontinued.

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Research and development expenses account for a significant portion of our operating expenses.

Our research and development expenses consist primarily of direct and indirect costs incurred in connection with the development of our research platform, product candidates, discovery efforts and preclinical studies related to our program pipeline.

Our direct costs include:

● expenses incurred under agreements with contract research organizations, or CROs, and other vendors that conduct our preclinical activities on our behalf;

including laboratory expenses related to the execution of preclinical studies on our behalf;

● expenses associated with the manufacturing of our product candidates and preclinical material, including fees paid to contract manufacturers;

● expenses incurred under agreements with third-party contract research organizations, or CROs, and other vendors that conduct our preclinical and clinical activities on our behalf;

including clinical trial sites that conduct research and development activities on our behalf.

● laboratory expenses related to the execution of discovery programs, preclinical studies and clinical trials;

● costs related to production of clinical and preclinical materials, including fees paid to contract manufacturers;

● consulting fees and expenses related to preparation of initiation of clinical trials

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● facility and equipment related expenses, consisting of indirect and allocated expenses for rent, depreciation, maintenance of facilities, insurance, and other supplies.

We expense research and development costs as incurred.

Our direct research and development expenses are not currently tracked on a program-by-program basis, but we anticipate tracking costs on a program-by-program basis at the time IMM-1-104 enters clinical trials, which we expect to occur in the fourth quarter of 2022, assuming our IND application is accepted.

We expense research and development costs in the periods in which they are incurred.

We use our personnel and infrastructure resources across multiple research and development programs directed toward identifying and developing product candidates.

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A change in the outcome of any of these factors could mean a significant change in the costs and timing associated with the development of our current and future preclinical and clinical product candidates.

example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies or clinical trials, we could be required to expend significant additional financial resources and time on the completion of preclinical and clinical development.

For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development, or if we experience significant delays in execution of or enrollment in any of our preclinical studies or clinical trials, we could be required to expend significant additional financial resources and time on the completion of preclinical and clinical development.

We expect that our research and development expenses will substantially increase for the foreseeable future as we continue to implement our business strategy, which includes advancing our product candidates through clinical development, expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals for our product candidates that successfully complete clinical trials.

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Results of Operations

Comparison of the Three Months Ended June 30, 2022 and 2021

Comparison of the Three Months Ended September 30, 2022 and 2021

The following table summarizes our results of operations for the periods indicated:

Three Months Ended June 30,

Three Months Ended September 30,

(in thousands, except percentages)

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Interest income

Other expense

Other income (expense)

N/M – Not meaningful

The following table summarizes the revenue recognized for the periods indicated:

Three Months Ended June 30,

Three Months Ended September 30,

(in thousands, except percentages)

Revenue decreased by approximately $0.6 million, or 85.8%, to approximately $0.1 million for the three months ended June 30, 2022 compared to approximately $0.7 million for the three months ended June 30, 2021.

The decrease in revenue was due to approximately $0.6 million decrease in existing customers in the three months ended June 30, 2022 compared to June 30, 2021.

Revenue decreased by approximately $0.4 million, or 92.1%, to approximately $38 thousand for the three months ended September 30, 2022 compared to approximately $0.5 million for the three months ended September 30, 2021.

The decrease in revenue was due to the decrease and wind down of the numbers and scope of customer agreements in the three months ended September 30, 2022 compared to September 30, 2021 (approximately $0.4 million).

Cost of Revenue

Cost of revenue decreased by approximately $0.3 million, or 85.0%, to approximately $50 thousand for the three months ended June 30, 2022 compared to approximately $0.3 million for the three months June 30, 2021.

The decrease was primarily due to decreased employee-related costs of approximately $0.3 million related to services contracts.

Cost of revenue decreased by approximately $0.2 million, or 91.3%, to approximately $19 thousand for the three months ended September 30, 2022 compared to approximately $0.2 million for the three months September 30, 2021.

The decrease was primarily due to decreased employee-related costs of approximately $0.2 million related to services contracts that were terminated during this period.

Research and Development

The following table summarizes the components of our research and development expenses for the periods indicated:

Three Months Ended June 30,

Three Months Ended September 30,

(in thousands, except percentages)

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Total research and development

Research and development expenses increased by approximately $1.0 million, or 14.1%, to approximately $8.0 million for the three months ended June 30, 2022 compared to approximately $7.0 million for the three months ended June 30, 2021.

The increase of approximately $1.0 million was primarily due to approximately $1.2 million of additional employee-related costs, approximately $0.3 million increase for equity-based compensation expense, an increase of $1.0 million for facilities, depreciation and other allocated expenses offset by approximately $1.5 million decrease in outside contract research services for preclinical candidates due to savings in outside consultant costs that were related to BioArkive which are now incorporated in the employee and facility related costs.

N/M – Not meaningful

Research and development expenses increased by approximately $3.2 million, or 50.9%, to approximately $9.4 million for the three months ended September 30, 2022 as compared to approximately $6.2 million for the three months ended September 30, 2021.

The increase of approximately $3.2 million was primarily due to an increase of approximately $1.6 million related to additional employee-related costs and $0.2 million related to equity-based compensation expense, primarily driven by increased headcount.

Depreciation, facilities and other allocated expense also increased by approximately $2.0 million in aggregate.

Increases in total research and development are partially offset by a decrease of $0.7 million in outside contract research services for preclinical candidates which is due to savings in outside consultant costs that were related to BioArkive which are now incorporated in the employee and facility related costs.

General and Administrative

The following table summarizes the components of our general and administrative expenses for the periods indicated:

Three Months Ended June 30,

Three Months Ended September 30,

(in thousands, except percentages)

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Total general and administrative

General and administrative expenses increased by approximately $2.4 million, or 176.3%, to approximately $3.7 million for the three months ended June 30, 2022 compared to approximately $1.3 million for the three months ended June 30, 2021.

The increase of approximately $2.4 million was primarily due to an increase in employee-related costs and equity-based compensation expense of approximately $1.9 million, increased facilities and allocated expenses of approximately $0.3 million, increased professional fees for accounting, auditing and legal of $0.1 million and approximately $0.1 million in other expenses as a result of the Company becoming a public company in the third quarter of 2021.

General and administrative expenses increased by approximately $1.2 million, or 47.6%, to approximately $3.8 million for the three months ended September 30, 2022 compared to approximately $2.6 million for the three months ended September 30, 2021.

The increase of approximately $1.2 million was primarily due to an increase in employee-related costs of approximately $0.4 million, increased equity-based compensation expense of $0.3 million, increased facilities and

allocated expenses of approximately $0.4 million, increased professional fees for accounting, auditing and legal of $0.2 million, and approximately $0.1 million in other expenses as a result of the Company becoming a public company in the third quarter of 2021.

Amortization of Intangible Asset

Amortization of intangible asset of $7,317 in the three months ended June 30, 2022 is related to the technology acquired for the BioArkive acquisition completed in December 2021.

Amortization of intangible asset of $7,317 in the three months ended September 30, 2022 is related to the technology acquired for the BioArkive acquisition completed in December 2021.

Other Income (expense)

Interest income increased by approximately $0.2 million due to the interest earned on our cash and cash equivalents and marketable securities balances due to the higher balances as a result of the IPO proceeds.

Other expense increased by $127,000 as a result of the increase in the amortization of premiums related to our marketable securities.

Comparison of the Six Months June 30, 2022 and 2021

Other expense increased by approximately $129 thousand as a result of the increase in the amortization of premiums related to our marketable securities.

Comparison of the Nine Months September 30, 2022 and 2021

The following table summarizes our results of operations for the periods indicated:

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands, except percentages)

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Other income (expense)

N/M – Not meaningful

The following table summarizes the revenue recognized for the periods indicated:

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands, except percentages)

Revenue decreased by approximately $1.1 million, or 80.3%, to approximately $0.3 million for the six months ended June 30, 2022 compared to approximately $1.4 million for the six months ended June 30, 2021.

The decrease in revenue was due to the decrease and wind down of the numbers and scope of customer agreements in 2022 compared to 2021.

Revenue decreased by approximately $1.6 million, or 83.3%, to approximately $0.3 million for the nine months ended September 30, 2022 compared to approximately $1.9 million for the nine months ended September 30, 2021.

in revenue was due to the decrease and wind down of the numbers and scope of customer agreements in 2022 compared to 2021.

Costs of Revenue

Cost of revenue decreased by approximately $0.6 million, or 80.9%, to approximately $0.1 million for the six months ended June 30, 2022 compared to approximately $0.7 million for the six months ended June 30, 2021.

Cost of revenue decreased by approximately $0.8 million, or 83.3%, to approximately $0.2 million for the nine months ended September 30, 2022 compared to approximately $0.9 million for the nine months ended September 30, 2021.

The decrease was primarily due to decreased employee related costs as a result of the wind down of the customer agreements in 2022 compared to 2021.

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The following table summarizes the components of research and development expenses for the periods indicated:

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands, except percentages)

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Total research and development

Research and development expenses increased by approximately $4.6 million, or 37.5%, to approximately $17.0 million for the six months ended June 30, 2022 as compared to approximately $12.4 million for the year ended June 30, 2021.

The increase of approximately $4.6 million was primarily due to an increase of approximately $3.6 million related to additional employee related costs, primarily due to higher headcount and increased equity-based compensation, facilities and other allocated expense of approximately $2.5 million.

Increases in research and development are partially offset by a decrease of $1.5 million in outside contract research services for preclinical candidates which is due to savings in outside consultant costs that were related to BioArkive which are now incorporated in the employee and facility related costs.

N/M – Not meaningful

Research and development expenses increased by approximately $7.8 million, or 42.0%, to approximately $26.4 million for the nine months ended September 30, 2022 as compared to approximately $18.6 million for the year ended September 30, 2021.

The increase of approximately $7.8 million was primarily due to an increase of approximately $4.5 million related to additional employee-related costs and $0.9 million related to equity-based compensation expense, primarily driven by increased headcount.

Depreciation, facilities and other allocated expense also increased by approximately $4.5 million in aggregate.

Increases in total research and development are partially offset by a decrease of $2.1 million in outside contract research services for preclinical candidates which is due to savings in outside consultant costs that were related to BioArkive which are now incorporated in the employee and facility related costs.

General and Administrative

The following table summarizes the components of general and administrative expenses for the periods indicated:

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands, except percentages)

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Total general and administrative

General and administrative expenses increased by approximately $5.1 million, or 203.6%, to approximately $7.6 million for the six months ended June 30, 2022 compared to approximately $2.5 million for the six months ended June 30, 2021 as a result of the Company becoming a public company in third quarter of 2021.

The increase of approximately $5.1 million was primarily due to increased employee related costs and equity-based compensation expense of approximately

$3.9 million, increased professional fees incurred for accounting, auditing, legal, and tax services of approximately $0.3 million, increase of $0.7 million for facilities and other allocated expense, increase of $0.2 million in other expenses.

N/M – Not meaningful

General and administrative expenses increased by approximately $6.4 million, or 124.5%, to approximately $11.5 million for the nine months ended September 30, 2022 compared to approximately $5.1 million for the nine months ended September 30, 2021 as a result of the Company becoming a public company in third quarter of 2021.

The increase of approximately $6.4 million was primarily due to increased employee related costs of $3.5 million, an increase of $1.1 million for facilities and other allocated expense, increased equity-based compensation expense of approximately $1.0 million, increased professional fees incurred for accounting, auditing, legal, and tax services of approximately $0.3 million, and an increase of $0.5 million in other expenses.

Amortization of Intangible Asset

Amortization of intangible asset of $15,420 in the six months ended June 30, 2022 is related to the technology acquired for the BioArkive acquisition completed in December 2021.

Amortization of intangible asset of $22,737 in the nine months ended September 30, 2022 is related to the technology acquired for the BioArkive acquisition completed in December 2021.

Other Income (Expense), Net

Interest income increased by approximately $0.5 million due to the interest earned on our cash and cash equivalents and marketable securities balances due to the higher balances as a result of the IPO proceeds.

Other expense increased by $0.1 million as a result of the increase in the amortization of premiums related to our marketable securities.

Other expense decreased as a result of the increase in the amortization of premiums related to our marketable securities.

Liquidity and Capital Resources

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Since our inception, we have financed our operations through service revenues, the issuance of convertible notes payable, convertible preferred stock, common stock, and the exercise of stock options.

As of June 30, 2022, we had an accumulated deficit of $83.7 million and $128.1 million in cash and cash equivalents and marketable securities.

Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase.

Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.

Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, reflected in the change in our outstanding accounts payable and accrued expenses.

In September 2022, we completed our last remaining services contract and, at this time, we do not anticipate entering into any new service contracts or agreements.

Based upon our current business plans, we believe that our existing cash and cash equivalents and marketable securities will be sufficient to fund our development activities and other operations into the third quarter of 2024.

Since our inception, we have incurred significant operating losses.

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We received aggregate net proceeds of approximately $120.3 million from the IPO, after deducting underwriting discounts and commissions, but before deducting offering costs payable by us, which were $2.1 million.

As of June 30, 2022, we have contractual obligations related to various leases of $0.3 million for 2022, $0.8 million for 2023, $0.7 million for 2024, $0.7 million for 2025, $0.8 million for 2026 and $4.5 million for the periods thereafter.

On August 10, 2022, we entered into an Equity Distribution Agreement, or the Sales Agreement, with Piper Sandler & Co, or the Sales Agent, to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through an “at the market” equity offering program.

For the three months ended September 30, 2022, we did not sell any shares of common stock under the Sales Agreement.

As of September 30, 2022, we have contractual obligations related to various leases of $0.1 million for 2022, $0.8 million for 2023, $0.7 million for 2024, $0.7 million for 2025, $0.8 million for 2026 and $4.5 million for the periods thereafter.

We have no off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.

The following table summarizes our sources and uses of cash for the periods indicated:

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

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Net Cash Used in Operating Activities

During the six months ended June 30, 2022, operating activities used approximately $21.7 million of cash, primarily resulting from our net loss of approximately $24.4 million, partially offset by right-of-use asset amortization of $0.3 million and equity-based compensation expense of approximately $2.0 million.

During the six months ended June 30, 2021, operating activities used approximately $12.6 million of cash, primarily resulting from our net loss of approximately $14.2 million partially offset by cash provided by changes in our operating assets and liabilities of approximately $1.0 million, and equity-based compensation expense of approximately $0.5 million.

During the nine months ended September 30, 2022, operating activities used approximately $32.4 million of cash, primarily resulting from our net loss of approximately $37.3 million, partially offset by right-of-use asset amortization of $0.4 million and equity-based compensation expense of approximately $3.0 million.

During the nine months ended September 30, 2021, operating activities used approximately $21.6 million of cash, primarily resulting from our net loss of approximately $22.8 million and cash provided by changes in our operating assets and liabilities of approximately $0.1 million, partially offset by equity-based compensation expense of approximately $1.2 million.

Net Cash Provided by (Used in) Investing Activities

During the six months ended June 30, 2022, investing activities provided approximately $34.6 million of cash, primarily resulting from the maturities of marketable securities of approximately $52.8 million, partially offset by purchases of marketable securities for $18.0 million and purchases of property and equipment of $0.3 million.

During the six months ended June 30, 2021, cash used in investing was $36,388, resulting from purchases of property and equipment.

During the nine months ended September 30, 2022, investing activities provided approximately $33.7 million of cash, primarily resulting from the maturities of marketable securities of approximately $72.1 million, partially offset by purchases of marketable securities for $37.7 million and purchases of property and equipment of $0.7 million.

During the nine months ended September 30, 2021, investing activities used approximately $52.8 million, primarily resulting from the purchases of marketable securities of approximately $52.8 million.

Net Cash Provided by Financing Activities

During the six months ended June 30, 2022, net cash provided by financing activities was approximately $0.2 million, consisting of approximately $0.2 million from the exercise of stock options.

During the six months ended June 30, 2021, net cash provided by financing activities was approximately $25.8 million, consisting primarily of approximately $24.8 million in net proceeds received from the issuance of Series B preferred stock and approximately $1.0 million in net proceeds from the exercise of warrants and approximately $52,627 from the exercise of stock options.

During the nine months ended September 30, 2022, net cash provided by financing activities was approximately $0.2 million, consisting of approximately $0.3 million from the exercise of stock options, offset by $0.1 million of payments towards offering costs.

During the nine months ended September 30, 2021, net cash provided by financing activities was approximately $144.3 million, consisting primarily of approximately $24.8 million in net proceeds received from the issuance of Series B preferred stock, approximately $118.2 million from the proceeds from our initial public offering, approximately $1.0 million in net proceeds from the exercise of warrants and approximately $0.3 million from the exercise of stock options.

Future Funding Requirements

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● the impacts of the pandemic related to COVID-19 and its variants and potential future pandemics;

● the costs and results of our potential future clinical trials for our other product candidates;

● the scope, progress, results and costs of discovery research, preclinical development, laboratory testing and clinical trials for our other product candidates;

● the costs and results of our current and future clinical trials for our product candidates;

● the scope, progress, results and costs of discovery research, preclinical development, laboratory testing and clinical trials for our product candidates;

● the costs, timing and outcome of regulatory review of our product candidates;

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● the costs of operating as a public company.

We believe that our existing cash, cash equivalents and marketable securities, will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2024.

Based on our current business plans, we believe that our existing cash, cash equivalents and marketable securities, will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2024.

We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

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This provision allows an EGC to delay the adoption of some accounting standards until those standards would otherwise apply to private companies.

We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies

until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.

We have elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act.

As a result, our condensed consolidated financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis