Inhibikase Therapeutics Inc

Previous wording

If we are unable to successfully raise additional capital, our future clinical trials and product development could be limited and our long-term viability may be threatened;

Current wording

If we are unable to successfully raise additional capital, particularly with respect to our neurodegenerative programs, our future clinical trials and product development could be limited and our long-term viability may be threatened;

Previous wording

We have concentrated much of our research and development efforts on the treatment of neurodegenerative diseases, a field that has seen limited success in drug development;

Current wording

We have concentrated much of our research and development efforts to date on the treatment of neurodegenerative diseases, a field that has seen limited success in drug development, although we now intend to expend considerable resources on PAH;

Previous wording

On January 19, 2024, members of the Company along with its medical oncology consultants met with the FDA Review Team (the “Review Team”) from the Division of Hematologic Malignancies in a Pre-New Drug Application, or NDA, meeting to discuss our bioequivalence studies of IkT-001Pro and its path to approval. All questions were addressed and summarized in official meeting minutes issued by the FDA on February 12, 2024. During the meeting we inquired whether additional clinical studies may be needed to seek approval and discussed manufacturing and quality control requirements for approval. The Review Team acknowledged that the 505(b)(2) pathway appears to be the appropriate pathway for approval of IkT-001Pro and indicated that, pending formal review of our clinical data, clinical studies completed to date indicate that 600 mg and 800 mg IkT-001Pro provides similar exposures to 400 mg and 600 mg imatinib mesylate, respectively, subject to review of the NDA upon filing. In addition, given that imatinib mesylate is approved for use between 300 mg and 800 mg once daily for a variety of blood and gastrointestinal cancers, the Review Team stated that if we intend to seek approval across all currently approved indications, we should evaluate additional dose(s) as needed to measure the safety, tolerability and bioequivalent dose of IkT-001Pro that would deliver up to 800 mg, the highest approved dose of imatinib mesylate. The Review Team also discussed the possible difference between IkT-001Pro and imatinib mesylate absorption in the gut and recommended that we evaluate whether IkT-001Pro and imatinib mesylate behave differently with respect to certain gut transporters that regulate absorption. This evaluation is now ongoing. Finally, a number of recommendations were discussed to prevent the potential mix-up between IkT-001Pro and imatinib mesylate either at the pharmacy or by patients for two drugs delivering the same active ingredient. We discussed alternate dosage forms for IkT-001Pro relative to imatinib mesylate as the primary mitigation strategy and will provide a justification of the dosage forms chosen and why they are unlikely to cause medication errors. To ensure that we meet the manufacturing requirements for approval, we will request milestone-based meetings with the Review Team as we complete the required manufacturing and quality control processes.

Current wording

IkT-001 Pro and PAH. IkT-001Pro emerged from the Company’s medicinal chemistry program that aimed to improve on-dosing side effects for drugs that inhibit the Abelson Tyrosine Kinase family. IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate, was designed to mask areas of the molecule that might play a role in the on-dosing GI and other side effects commonly observed with oral imatinib mesylate. A three-part dose finding/dose equivalence study in 66 healthy volunteers (known as ‘the 501 trial’) was completed with IkT-001Pro in 2023. The study was designed to evaluate the 96-hour single-dose pharmacokinetics of imatinib delivered as IkT-001Pro and determine the dose of IkT-001Pro that can deliver the equivalent of either 400 mg or 600 mg imatinib mesylate. Bioequivalence to 400 mg imatinib mesylate was established to our satisfaction for a 600 mg dose of IkT-001Pro. We further evaluated 600 mg imatinib mesylate and believe that a dose between 800 mg and 900 mg of IkT-001Pro is the preferred dose of IkT-001Pro to deliver a dose of imatinib equivalent to 600 mg imatinib mesylate. On January 19, 2024, members of the Company along with its medical consultants met with the FDA Hematological Malignancy Review Team (the “Review Team”) in a Pre-New Drug Application, or pre-NDA, meeting to discuss our bioequivalence studies of IkT-001Pro and its path to approval. All questions were addressed and summarized in official meeting minutes issued by the FDA on February 12, 2024. During the meeting, we inquired whether additional clinical studies would be needed to seek approval and discussed manufacturing and quality control requirements for approval. The Review Team acknowledged that the 505(b)(2) pathway appeared to be the appropriate pathway for approval of IkT-001Pro and indicated that, pending formal review of our clinical data, clinical studies completed to date indicate that

Previous wording

We are also evaluating the application of IkT-001Pro to pulmonary arterial hypertension (PAH). PAH is a rare disease of the pulmonary microvasculature with about 30,000 cases in the U.S., mostly in women between the ages of 30 and 60. The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a compound annual growth rate of 5.4% between 2024 to 2030. Most treatments for PAH attempt to address symptoms of this progressive disorder, but in the early 2010s, imatinib delivered by imatinib mesylate was shown to be a disease-modifying therapy for PAH. Co-administration of medications with harmful drug-drug interactions precluded the approval of imatinib as add-on therapy in PAH. Today, due to changes to standard-of-care for these patients, we believe the safety risk has been reduced and we plan to evaluate imatinib delivered by IkT-001Pro for PAH. As such, on April 5, 2024, members of the Company met with the FDA Division of Cardiology and Nephrology in a pre-IND meeting to discuss the Company’s plan to utilize IkT-001Pro at 300 mg or 450 mg in a Phase 2/3 efficacy, safety and tolerability trial in World Health Organization Functional Class I patients. At the meeting, the FDA confirmed that IkT-001Pro would be viewed as a New Molecular Entity (NME) for PAH and that the appropriate path for approval appears to be the 505(b)(2) statute. This opens up the possibility of IkT-001Pro being granted NME and patent exclusivity on approval. The period of exclusivity would be evaluated once the NDA is filed. The FDA requested that we conduct a comparative cell-culture based study of the hERG ion channel, a standard cardiovascular safety test performed for any NME for which a new IND is to be opened. The Company has completed this study and filed the IND on August 9, 2024. The Company is in active discussion with potential strategic partners on this program. The Company has also applied for Orphan Drug Designation for delivery of imatinib by IkT-001Pro for PAH.

Current wording

In 2013, the outcome of a Phase 3 trial evaluating imatinib mesylate as a treatment for PAH was reported, demonstrating that imatinib can modify the course of disease in PAH. Co-administration of medications with harmful drug-drug interactions precluded the approval of imatinib as add-on therapy in PAH despite the success of the Phase 3 trial. PAH is a rare disease of the pulmonary microvasculature, with about 30,000 cases in the U.S. that principally afflicts women between the ages of 30 and 60. The global PAH market size was valued at $7.66 billion in 2023 and is estimated to grow at a compound annual growth rate (CAGR) of 5.4% between 2024 to 2030. As the Company considered revisiting the use of imatinib in PAH, the Company recognized that changes in standard-of-care for these patients may have alleviated much of the safety risk previously observed for imatinib in PAH patients. This analysis prompted the Company to file a pre-IND (PIND) meeting request to discuss the application of IkT-001Pro as a potential disease-modifying treatment for PAH. To evaluate this further, members of the Company met with the FDA Division of Cardiology and Nephrology in a PIND meeting to discuss the Company’s plan to utilize IkT-001Pro at 300 mg or 500 mg in a Phase 2b efficacy, safety and tolerability study in PAH. At the meeting, the FDA confirmed that IkT-001Pro would be viewed as a New Molecular Entity (NME) and that the appropriate path for approval remained to be the 505(b)(2) statute. This opens up the possibility of IkT-001Pro being granted NME status and patent exclusivity on approval. The FDA requested at the PIND meeting that we conduct a comparative cell-culture based study of the hERG ion channel, a standard cardiovascular safety test performed for any NME for which a new IND is to be opened. Neither IkT-001Pro nor imatinib mesylate were found to be inhibitors of hERG. Following completion of this study, the IND was filed with the FDA on August 9, 2024 and cleared to initiate a Phase 2b trial on September 9, 2024. On October 21, 2024, the Company closed a private placement with an initial investment of approximately $110 million, before deducting placement fees and offering expenses, to support this program. If the warrants are exercised for cash, the aggregate financing may be up to $275 million. The Company intends to use the net proceeds from the private placement to finance the initiation of a Phase 2b trial in PAH and for general corporate purposes. The Company has also applied for Orphan Drug Designation for delivery of imatinib by IkT-001Pro for PAH.

Previous wording

In March 2023, we opened our Investigational New Drug Application, or IND, for Risvodetinib (IkT-148009) as a treatment for the Parkinson’s-related orphan disease Multiple System Atrophy, or MSA. Our evaluation of Risvodetinib (IkT-148009) in MSA was benefited by a grant received from the National Institute of Neurological Diseases and Stroke, an Institute of the National Institutes of Health, for $0.39 million to fund animal model studies of Risvodetinib (IkT-148009) as a therapy for MSA. Two different animal studies were undertaken to evaluate whether Risvodetinib (IkT-148009) could have an impact on disease in the animal. One model evaluated the ability of Risvodetinib (IkT-148009) to modify disease early in its progression, while the second model is evaluating whether Risvodetinib (IkT-148009) can correct functional loss much later in the disease course. The early progression model study has now been shown to preserve nearly normal functional activity following 20 weeks of once daily dosing relative to untreated controls. Preservation of function in this model occurred with substantial reduction of the underlying alpha-synuclein protein pathology. The second model evaluating Risvodetinib (IkT-148009) late in the disease course is ongoing. In addition, Risvodetinib (IkT-148009) was recently given Orphan Drug Designation by the FDA for the treatment of MSA. We are working with the National Institute of Neurological Diseases and Stroke to possibly initiate a Phase 2/3 program to evaluate Risvodetinib (IkT-148009) as a treatment for MSA through a clinical trial network supported by the Institute. The proposed Phase 2/3 study will have a primary efficacy endpoint following once daily dosing at one of two dose levels for twelve months. We plan to submit complementary regulatory documents for Risvodetinib (IkT-148009) to European Union authorities in 2024.

Current wording

In March 2023, we opened our IND to evaluate risvodetinib (IkT-148009) as a treatment for the Parkinson’s-related orphan disease Multiple System Atrophy, or MSA. Our evaluation of risvodetinib (IkT-148009) in MSA was benefited by a grant received from the National Institute of Neurological Diseases and Stroke, an Institute of the National Institutes of Health, for $0.39 million to fund animal model studies of risvodetinib (IkT-148009) as a therapy for MSA. Two different animal studies were undertaken to evaluate whether risvodetinib (IkT-148009) could have an impact on disease in the animal. One model evaluated the ability of risvodetinib (IkT-148009) to modify disease early in its progression, while the second model is evaluating whether risvodetinib (IkT-148009) can correct functional loss much later in the disease course. The early progression model study has now been shown to preserve nearly normal functional activity following 20 weeks of once daily dosing relative to untreated controls. Preservation of function in this model occurred with substantial reduction of the underlying alpha-synuclein protein pathology. The second model evaluating risvodetinib (IkT-148009) late in the disease course is ongoing. In addition, risvodetinib (IkT-148009) was recently given Orphan Drug Designation by the FDA for the treatment of MSA. We are working with the National Institute of Neurological Diseases and Stroke to possibly initiate a Phase 2/3 program to evaluate risvodetinib (IkT-148009) as a treatment for MSA through a clinical trial network supported by the Institute. The proposed Phase 2/3 study will have a primary efficacy endpoint following once daily dosing at one of two dose levels for twelve months. We plan to submit complementary regulatory documents for risvodetinib (IkT-148009) to European Union authorities in 2024 or 2025.

Previous wording

Finally, we are evaluating a number of research phase molecules (IkT-148x and BIP 4-7) for a variety of neurodegenerative disease indications across our pre-clinical development pipeline.

Current wording

Finally, we are evaluating a number of research phase molecules (IkT-148x and BIP 4-7) for a variety of neurodegenerative disease indications across our pre-clinical development pipeline. A similar effort has begun to identify novel, second generation candidate molecules for PAH.

Previous wording

To increase the probability of success, we are making parallel investments in several product candidates and back-up candidates, and plan to advance only those candidates to the later stages of clinical development that show strong preclinical and early clinical data. By developing a portfolio of product candidates across therapeutic indications, we can continuously apply learnings and tools across programs and leverage economies of scale in our research and development organization. Our target indications include diseases with large patient populations, such as PD, as well as orphan indications, such as, Multiple System Atrophy and Chronic Myelogenous Leukemia.

Current wording

To increase the probability of success, we are making parallel investments in several product candidates and back-up candidates, and plan to advance only those candidates to the later stages of clinical development that show strong preclinical and early clinical data. By developing a portfolio of product candidates across therapeutic indications, we can continuously apply learnings and tools across programs and leverage economies of scale in our research and development organization. Our target indications include orphan indications, such as PAH and Multiple System Atrophy, and diseases with large patient populations, such as PD.

Previous wording

Grant revenue for the three months ended June 30, 2024, decreased by $116,410 or 100.0% to $0 from $116,410 in the prior comparable period. During 2024, the Company continued to advance its Phase I and II clinical trials which were not submitted for grant revenue.

Current wording

Grant revenue for the three months ended September 30, 2024, decreased by $79,569 or 100.0% to $0 from $79,569 in the prior comparable period. During 2024, the Company continued to advance its Phase I and II clinical trials for PD which were not submitted for grant revenue. The Company has no active grants during the period ended September 30, 2024.

Previous wording

Research and development expenses decreased by $1,459,868 or 32.2% to $3,075,830 from $4,535,698 in the prior comparable period. The $1.5 million decrease in research and development expenses was due to a decrease of $1.4 million in IkT-001 Pro expenses due to the completion of the three-part dose finding/dose equivalence study in 2023 and a net decrease of $0.1 million in other research and development expenses.

Current wording

Research and development expenses increased by $964,322 or 29.9% to $4,189,873 from $3,225,551 in the prior comparable period. The $1.0 million increase in research and development expenses was due to an increase of $0.8 million in PAH expenses and a net increase of $0.2 million in other research and development expenses.

Previous wording

Selling, general and administrative expenses increased by $297,322 or 8% to 4,005,786 from $3,708,464 in the prior comparable period. The $297,322 increase was primarily driven by a $0.5 million increase in legal and consulting fees partially offset by a $0.2 million decrease in D&O insurance, a $0.1 million decrease in investor relations costs and a $0.1 million net increase in all other normal selling, general and administrative expenses.

Current wording

Selling, general and administrative expenses increased by $14,709 or 0.9% to $1,637,603 from $1,622,894 in the prior comparable period. The $14,709 increase was primarily driven by a $273,000 decrease in advertising and promotion, an $80,000 decrease in D&O insurance and a $338,000 net increase in all other normal selling, general and administrative expenses.

Previous wording

Interest income decreased by $333,508 or 78.6% to $90,927 from $424,435 in the prior comparable period. The decrease was driven by a reduction in interest earned on U.S. Treasuries and money market instruments.

Current wording

Interest income decreased by $124,267 or 71.6% to $49,410 from $173,677 in the prior comparable period. The decrease was driven by a reduction in interest earned on U.S. Treasuries and money market instruments.

Previous wording

Grant revenue for the six months ended June 30, 2024, decreased by $180,931 or 100% to $0 from $180,931 in the prior comparable period. During 2024, the Company continued to advance its Phase I and Phase II clinical trials which were not submitted for grant revenue.

Current wording

Grant revenue for the nine months ended September 30, 2024, decreased by $260,500 or 100% to $0 from $260,500 in the prior comparable period. During 2024, the Company continued to advance its Phase I and Phase II clinical trials for PD which were not submitted for grant revenue. The Company has no active grants during the period ended September 30, 2024.

Previous wording

Research and development expenses decreased by $1,562,708 or 21.1% to $5,827,109 from $7,389,817 in the prior comparable period. The $1,562,708 decrease in research and development expenses was due to a decrease of $2.2 million in IkT-001 Pro expenses due to the completion of the three-part dose finding/dose equivalence study in 2023 partially offset by $0.8 million increase in Risvodetinib (IkT-148009) expenses and a net decrease of $0.2 million in other research and development expenses.

Current wording

Research and development expenses decreased by $598,386 or 5.6% to $10,016,982 from $10,615,368 in the prior comparable period. The $0.6 million decrease in research and development expenses was due to a decrease of $2.1 million in CML expenses due to the completion of the three-part dose finding equivalence study in 2023 partially offset by an increase of $0.8 million in PAH expenses, a $0.9 million increase in risvodetinib (IkT-148009) expenses and a net decrease of $0.2 million in other research and development expenses.

Previous wording

Selling, general and administrative expenses increased by $191,592 or 10.7% to $1,974,705 from $1,783,113 in the prior comparable period. The $0.2 million increase was primarily driven by a $0.4 million increase in legal and consulting fees partially offset by a $0.1 million decrease in D&O insurance and a $0.1 million net decrease in all other normal selling, general and administrative expenses.

Current wording

Selling, general and administrative expenses increased by $312,028 or 5.9% to $5,643,386 from $5,331,358 in the prior comparable period. The $0.3 million increase was primarily driven by a $0.7 million increase in legal and consulting fees partially offset by a $0.2 million decrease in D&O insurance, a $0.3 million decrease in advertising and promotions and a $0.1 million net increase in all other normal selling, general and administrative expenses.

Previous wording

Interest income decreased by $437,954 or 66.2% to $223,652 from $661,606 in the prior comparable period. The decrease was driven by a reduction in interest earned on U.S. Treasuries and money market instruments.

Current wording

Interest income decreased by $562,224 or 67.3% to $273,059 from $835,283 in the prior comparable period. The decrease was driven by a reduction in interest earned on U.S. Treasuries and money market instruments.

Previous wording

From our inception up until our December 2020 IPO, we funded our operations primarily through private, state and federal contracts and grants. From our inception through June 30, 2024, we generated aggregate cash proceeds of approximately $23.6 million from private, state and federal contracts and grants. In December 2020, June 2021, January 2023, and May 2024, the Company raised approximately $14.6 million, $41.1 million, $8.5 million, and $3.2 million respectively, in net proceeds from its 2020 IPO, its June 2021 Offering, its January 2023 Offering, and its May 2024 Offering, respectively.

Current wording

From our inception up until our December 2020 IPO, we funded our operations primarily through private, state and federal contracts and grants. In October 2024, the Company raised approximately $110 million in gross proceeds from its October 2024 Offering.

Previous wording

On February 1, 2024, the Company entered into an ATM with H.C. Wainwright & Co., LLC as sales agent (the “Agent”), pursuant to which the Company may, from time to time, issue and sell shares of its Common Stock, in an aggregate offering price of up to $5.7 million through the Agent. Under the terms of the ATM, the Agent may sell the shares of Common Stock at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act. On May 20, 2024, the Company reduced the aggregate offering price to $50,000, not including the shares of common stock previously sold. As of June 30, 2024, 315,338 Shares have been sold under the Agreement with net proceeds of $820,509 to the Company.

Current wording

On February 1, 2024, the Company entered into an ATM with H.C. Wainwright & Co., LLC as sales agent (the “Agent”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, in an aggregate offering price of up to $5.7 million through the Agent. Under the terms of the ATM, the Agent may sell the shares of common stock at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act. On May 20, 2024, the Company reduced the aggregate offering price to $50,000, not including the shares of common stock previously sold. As of September 30, 2024, 315,338 Shares have been sold under the ATM Agreement with net proceeds of $820,509 to the Company.

Previous wording

To date, we have not generated any revenue from the sale of commercial products. We do not expect to generate any significant revenue from product sales unless and until we obtain regulatory approval of and successfully commercialize any of our product candidates and we do not know when, or if, this will occur. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any future approved products. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. Moreover, following the completion of the December 2020 IPO, we incurred additional costs associated with operating as a public company. We anticipate that we will need substantial additional funding in connection with our continuing operations.

Current wording

To date, we have not generated any revenue from the sale of commercial products. We do not expect to generate any significant revenue from product sales unless and until we obtain regulatory approval of and successfully commercialize any of our product candidates and we do not know when, or if, this will occur. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin to commercialize any future approved products. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.

Previous wording

Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $76,509,968 at June 30, 2024. We expect to incur substantial additional losses in the future as we conduct and expand our research and development activities.

Current wording

Since our inception, we have incurred significant losses and negative cash flows from operations. We have an accumulated deficit of $82,288,034 at September 30, 2024. We expect to incur substantial additional losses in the future as we conduct and expand our research and development activities.

Previous wording

We believe that our existing cash resources as of June 30, 2024 will enable us to fund our operating requirements into December, 2024. However, we have based these estimates on assumptions that may prove to be wrong, and we could deplete our working capital sooner than planned.

Current wording

We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2024 and the gross proceeds of approximately $110 million the Company raised in October 2024, will enable us to fund our operating requirements for at least the next twelve months. However, we have based these estimates on assumptions that may prove to be wrong, and we could deplete our working capital sooner than planned.

Previous wording

Net cash flows used in operating activities for the six months ended June 30, 2024 , totaled $8,921,392, and consisted primarily of a net loss of $9.6 million adjusted for non-cash stock compensation of $0.1 million, a decrease in prepaid research and development of $0.1 million, an increase in accounts payable of $0.9 million, and a decrease in accrued expenses and other current liabilities of $0.2 million.

Current wording

Net cash flows used in operating activities for the nine months ended September 30, 2024, totaled $13,802,492, and consisted primarily of a net loss of $15.4 million adjusted for non-cash stock compensation of $0.2 million, a decrease in prepaid research and development of $0.1 million, an increase in accounts payable of $1.3 million, and a decrease in accrued expenses and other current liabilities of $0.1 million.

Previous wording

Net cash flows used in operating activities for the six months ended June 30, 2023, totaled $10,537,519, and consisted primarily of a net loss of $10.3 million adjusted for non-cash stock compensation of $0.2 million, depreciation and lease expense of $0.2 million, a decrease in accounts receivable of $39,721, decrease in prepaid expenses and other assets of $0.4 million, an increase in prepaid research and development of $0.7 million, decrease in accounts payable of $0.4 million, and a decrease in accrued expenses and other current liabilities of $0.6 million.

Current wording

Net cash flows used in operating activities for the nine months ended September 30, 2023, totaled $14,642,612, and consisted primarily of a net loss of $14.9 million adjusted for non-cash stock compensation of $0.4 million, depreciation and lease expense of $0.2 million, decrease in prepaid expenses and other assets of $0.2 million, increase in prepaid research and development of $0.8 million, decrease in accounts payable of $0.4 million, and a decrease in accrued expenses and other current liabilities of $0.5 million.

Previous wording

Net cash flows used in investing activities for the six months ended June 30, 2024, totaled $768,587, of which $9.2 million was used for the purchase of marketable securities investments and $8.4 million was provided by maturity of marketable securities.

Current wording

Net cash flows provided by investing activities for the nine months ended September 30, 2024, totaled $1,757,524, of which $10.3 million was used for the purchase of marketable securities investments and $12.1 million was provided by maturity of marketable securities.

Previous wording

Net cash flows used in investing activities for the six months ended June 30, 2023, totaled $3,288,963, of which $18.7 million was used for the purchase of marketable securities investments and $15.4 million was provided by maturity of marketable securities.

Current wording

Net cash flows provided by investing activities for the nine months ended September 30, 2023, totaled $13,772,261, of which $20.6 million was used for the purchase of marketable securities investments and $34.4 million was provided by maturity of marketable securities.

Previous wording

Net cash flows provided by financing activities for the six months ended June 30, 2024, totaled $3,611,255, which consisted of net proceeds from issuance of common stock and pre-funded warrants in with connection our May 2024 Offering and our ATM Offering.

Current wording

Net cash flows provided by financing activities for the nine months ended September 30, 2024, totaled $3,793,209, which consisted of $3.8 million of net proceeds from issuance of common stock and pre-funded warrants in connection with our May 2024 Offering and our ATM Offering.

Previous wording

Net cash flows provided by financing activities for the six months ended June 30, 2023, totaled $8,543,037, consisted of net proceeds from issuance of common stock and pre-funded warrants in connection with our January 2023 Offering.

Current wording

Net cash flows provided by financing activities for the nine months ended September 30, 2023, totaled $8,543,037, which consisted of net proceeds from issuance of common stock and pre-funded warrants in connection with our January 2023 Offering.

Previous wording

On April 18, 2022, the Company entered into an operating lease agreement through September 30, 2025 for its office space in Lexington, Massachusetts. The Lexington lease contains escalating payments during the lease period. Upon execution of this lease agreement, the Company prepaid one month of rent, applied to the first month's rent, and a security deposit, which will be held in escrow and credited at the termination of the lease. Our total lease obligation is $190,546, consisting of minimum annual rental obligations of $75,580 for fiscal year 2024 and $114,966 for fiscal year 2025.

Current wording

On April 18, 2022, the Company entered into an operating lease agreement through September 30, 2025 for its office space in Lexington, Massachusetts. The Lexington lease contains escalating payments during the lease period. Upon execution of this lease agreement, the Company prepaid one month of rent, applied to the first month's rent, and a security deposit, which will be held in escrow and credited at the termination of the lease. Our total lease obligation is $153,288, consisting of minimum annual rental obligations of $38,322 for fiscal year 2024 and $114,966 for fiscal year 2025.