Hoth Therapeutics Inc

Previous wording

We are a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. We are focused on developing (i) a topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001); (ii) a treatment for mast-cell derived cancers and anaphylaxis (HT-KIT); (iii) a treatment for traumatic brain injury and ischemic stroke (HT-TBI); and (iv) a treatment and/or prevention for Alzheimer’s or other neuroinflammatory diseases (HT-ALZ). We also have assets being developed for (i) atopic dermatitis (also known as eczema) (BioLexa); (ii) a treatment for asthma and allergies using inhalational administration (HT-004); and (iii) a treatment for acne as well as inflammatory bowel diseases (HT-003). Furthermore, we have interests in certain other assets being developed by third parties including a treatment for patients with lupus that is being developed by Zylö Therapeutics, Inc. and potential product candidates being developed pursuant to our agreement with Voltron Therapeutics, Inc. for the prevention of COVID-19.

Current wording

We are a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. We are focused on developing (i) a topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001); (ii) a treatment for mast-cell derived cancers and anaphylaxis (HT-KIT); and (iii) a treatment and/or prevention for Alzheimer’s or other neuroinflammatory diseases (HT-ALZ). We also have assets being developed for (i) atopic dermatitis (also known as eczema) (BioLexa); (ii) a treatment for asthma and allergies using inhalational administration (HT-004); and (iii) a treatment for obesity, and obesity-related diseases and conditions (HT-VA).

Previous wording

For the nine months ended September 30, 2024, research and development expenses were approximately $1.9 million. Specifically, during the nine months ended September 30, 2024, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $1.2 million related to manufacturing, preclinical and clinical activities; (ii) HT-ALZ, approximately $112,800 related to preclinical studies; (iii) HT-KIT, approximately $363,300 related to manufacturing and preclinical activities; and (iv) HT-004, approximately $96,100 in sponsored research activities. In addition to the foregoing, we also incurred fees of approximately $111,800 payable to members of our scientific advisory board for services.

Current wording

For the three months ended March 31, 2025, research and development expenses were approximately $2.0 million. Specifically, during the three months ended March 31, 2025, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $0.5 million related to manufacturing and clinical activities; (ii) HT-KIT, approximately $0.2 million related to manufacturing and preclinical activities; and (iii) HT-ALZ, approximately $12,000 related to preclinical studies. In addition to the foregoing, we also incurred fees of approximately $37,000 payable to members of our scientific advisory board for services and recorded approximately $1.3 million of in-process research and development expenses in connection with the acquisition of patent applications.

Previous wording

For the three months ended September 30, 2024, research and development expenses were approximately $0.9 million related to ongoing research and development projects. Specifically, during the quarter ended September 30, 2024, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $0.6 million related to manufacturing, preclinical and clinical activities; (ii) HT-KIT, approximately $154,300 related to manufacturing and preclinical activities; (iii) HT-004, approximately $18,700 in sponsored research activities; and (iv) HT-ALZ, approximately $96,500 related to manufacturing and preclinical activities. In addition to the foregoing, we also incurred fees of approximately $37,200 payable to members of our scientific advisory board for services.

Current wording

For the three months ended March 31, 2024, research and development expenses were approximately $0.6 million, of which approximately $3,000 was related to licenses acquired and approximately $0.5 million was related to other research and development expenses. Specifically, during the quarter ended March 31, 2024, our research and development costs consisted primarily of the following costs for each of our key research and development projects: (i) HT-001, approximately $0.4 million related to manufacturing, preclinical and clinical activities; (ii) HT-ALZ, approximately $16,000 related to preclinical studies; (iii) HT-KIT, approximately $77,000 related to manufacturing and preclinical activities; and (iv) HT-004, approximately $51,000 in sponsored research activities. In addition to the foregoing, we also incurred fees of approximately $37,000 payable to members of our scientific advisory board for services.

Previous wording

For the three months ended September 30, 2024, general and administrative expenses amounted to approximately $1.2 million as compared to $1.1 million for the three months ended September 30, 2023, an increase of approximately $116,100, or 10.4%. For the three months ended September 30, 2024 and 2023, general and administrative expenses consisted of the following:

Current wording

For the three months ended March 31, 2025, general and administrative expenses amounted to approximately $1.5 million as compared to $1.6 million for the three months ended March 31, 2024, a decrease of approximately $71,000, or 4.5%. For the three months ended March 31, 2025 and 2024, general and administrative expenses consisted of the following (rounded to the nearest $1,000):

Previous wording

During the nine months ended September 30, 2024, the increase in general and administrative expenses of approximately $473,500 was primarily attributed to an increase other general and administrative expenses of approximately $182,400, which primarily consisted of an increase in conference fees of approximately $161,000, an increase in compensation and related expenses of approximately $457,900, comprising of an increase in stock-based compensation of approximately $607,600 related to the issuance of stock options to executives and board of director members, and an increase in rent of approximately $10,100, offset by a decrease in other compensation and related expenses of approximately $149,700, and a decrease in professional and consulting expenses of approximately $176,900. During the nine months ended September 30, 2023, we received a vendor credit of approximately $139,400, which reduced our other general and administrative expenses for the period. We did not receive any credit in the 2024 period. During the nine months ended September 30, 2024, the increase in other general and administrative was also attributable to an increase in insurance expense and other general and administrative expenses.

Current wording

During the three months ended March 31, 2025, the decrease in general and administrative expenses of approximately $71,000 was primarily attributed to a decrease in compensation and related expenses of approximately $198,000, attributable to a decrease in stock-based compensation of approximately $293,000 related to the issuance of stock options to executives and board members, offset by an increase in compensation and related benefits of approximately $95,000, and an increase in other general and administrative expenses of approximately $12,000, and an increase in professional and consulting expenses of approximately $115,000, primarily attributable to an increase in investors relations fees, offset by a decrease in accounting fees.

Previous wording

For the three months ended September 30, 2024 and 2023, we incurred a net loss of approximately $2.1 million, or $0.31 per common share (basic and diluted), and $2.1 million, or $0.60 per common share (basic and diluted), respectively, a decrease of approximately $45,500.

Current wording

For the three months ended March 31, 2025 and 2024, we incurred a net loss of approximately $3.5 million, or $0.27 per common share (basic and diluted), and $2.1 million, or $0.49 per common share (basic and diluted), respectively.

Previous wording

To date we have funded our operations primarily through the sale of equity and debt securities. As of September 30, 2024, we had approximately $8.0 million in cash and cash equivalents, working capital of approximately $7.4 million and an accumulated deficit of approximately $58.7 million. Net cash used in operating activities was $5.0 million and $5.4 million for the nine months ended September 30, 2024 and 2023, respectively. We incurred net losses of approximately $5.8 million and $6.1 million for the nine months ended September 30, 2024 and 2023, respectively. We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future as we continue our pre-clinical and clinical development of our product candidates. We have not yet commercialized any products and have never generated any revenue from product sales. We believe that our existing cash as of September 30, 2024 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date of this Quarterly Report on Form 10-Q.

Current wording

To date we have funded our operations primarily through the sale of equity and debt securities. As of March 31, 2025, we had approximately $11.3 million in cash and cash equivalents, working capital of approximately $11.5 million and an accumulated deficit of approximately $63.9 million. Net cash used in operating activities was $2.8 million and $1.7 million for the three months ended March 31, 2025 and 2024, respectively. We incurred net losses of approximately $3.5 million and $2.1 million for the three months ended March 31, 2025 and 2024, respectively. We have incurred substantial operating losses since inception and expect to continue to incur significant operating losses for the foreseeable future as we continue our pre-clinical and clinical development of our product candidates. We have not yet commercialized any products and have never generated any revenue from product sales. We believe that our existing cash as of March 31, 2025 will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the date that our unaudited condensed consolidated financial statements are available to be issued.

Previous wording

On November 8, 2024, we entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC (“Wainwright”) under which we may offer and sell shares of our common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales manager. Sales of shares of our common stock through Wainwright, if any, will be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act. For additional information see Note 7 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Current wording

On November 8, 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”) under which we could offer and sell shares of our common stock having an aggregate sales price of up to $2,700,000 through Wainwright as the sales manager pursuant to our effective shelf registration statement on Form S-3 (File No. 333-272620), including an accompanying base prospectus and a prospectus supplement dated November 8, 2024. Sales of shares of the Company’s common stock through Wainwright, if any, will be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. Wainwright will use commercially reasonable efforts to sell shares of the Company’s common stock from time to time, based on instructions from us (including any price, time or size limits or other parameters or conditions we may impose). We will pay Wainwright a commission equal to 3.0% of the aggregate gross proceeds from the sales of shares of the Company’s common stock sold through Wainwright under the ATM Agreement and will also reimburse Wainwright for certain specified expenses in connection with the ATM Agreement. On February 7, 2025, the amount that the Company could offer and sell pursuant to the ATM Agreement was increased to $5,000,000 pursuant to a prospectus supplement dated February 7, 2025. The offering of shares pursuant to the ATM Agreement will terminate on the earlier of (1) the sale, pursuant to the ATM Agreement, of shares having an aggregate offering price of $5,000,000 and (2) the termination of the ATM Agreement by either us or Wainwright, as set forth therein. During the three months ended March 31, 2025 we issued 927,968 shares of our common stock for net proceeds of approximately $1.4 million pursuant to the ATM Agreement.

Previous wording

We have entered into certain license, sublicense, sponsored research and option agreements with third parties. Pursuant to such agreements, we may be required to make certain: (i) license maintenance fee payments; (ii) out-of-pocket expense payments, including, but not limited to, payments related to intellectual property and research related expenses; (iii) development and commercialization expense payments; (iv) annual and quarterly minimum payments; (v) diligence expense payments; and (vi) revenue interest payments. In addition, subject to the achievement of certain development and/or commercialization events, we may also be required to make certain: (i) minimum royalty payments, ranging from middle to high five figures; (ii) sales-based royalties and running royalties, ranging from low single digits to low double digits; and (iii) milestone payments of up to approximately $10.5 million (if all milestones in all of our current agreements are achieved).

Current wording

We have entered into certain license, sublicense, sponsored research and option agreements with third parties. Pursuant to such agreements, we may be required to make certain: (i) license maintenance fee payments; (ii) out-of-pocket expense payments, including, but not limited to, payments related to intellectual property and research related expenses; (iii) development and commercialization expense payments; (iv) annual and quarterly minimum payments; (v) diligence expense payments; and (vi) revenue interest payments. In addition, subject to the achievement of certain development and/or commercialization events, we may also be required to make certain: (i) minimum royalty payments, ranging from middle to high five figures, (ii) sales-based royalties and running royalties, ranging from low single digits to low double digits; and (iii) milestone payments, of up to approximately $30 million (if all milestones in all of our current agreements are achieved).

Previous wording

Additional funding will be necessary to fund our future clinical and pre-clinical activities. We may obtain additional financing through sales of our equity and debt securities, entering into strategic partnerships, grants or other arrangements, or a combination of the foregoing. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light of the economic downturn. If we are unable to secure adequate additional funding as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates.

Current wording

Additional funding will be necessary to fund our future clinical and pre-clinical activities. We may obtain additional financing through sales of our equity and debt securities or entering into strategic partnership arrangements, or a combination of the foregoing. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light of the economic downturn. If we are unable to secure adequate additional funding as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates.

Previous wording

For the nine months ended September 30, 2023, net cash used in operations was approximately $5.4 million, which primarily resulted from a net loss of approximately $6.1 million, adjusted for the add back of stock-based compensation of approximately $210,600 and unrealized loss on marketable securities of $184,800, and net changes in operating assets and liabilities of approximately $397,000, which consisted of an increase in prepaid expenses of $141,100 and an increase in accounts payable and accrued expenses of approximately $538,100.

Current wording

For the three months ended March 31, 2024, net cash used in operating activities was approximately $1.7 million, which primarily resulted from a net loss of approximately $2.1 million, adjusted for the add back of stock-based compensation of approximately $0.5 million, and changes in operating assets and liabilities consisting of an increase in prepaid expenses and other current assets of approximately $52,000 and a net decrease in accounts payable and accrued expenses of approximately $39,000.

Previous wording

For the nine months ended September 30, 2023, net cash provided by financing activities was approximately $11.3 million, which resulted from net proceeds from the issuance of common stock and warrants and proceeds from the exercise of warrants.

Current wording

For the three months ended March 31, 2025, net cash provided by financing activities was approximately $7.1 million, which primarily resulted from net proceeds from the issuance of common stock of $1.4 million and proceeds from the exercise of warrants of approximately $5.6 million.

Previous wording

The ASU is effective for annual periods beginning after December 15, 2024. The amendments should be applied on a prospective basis. The Company is evaluating the impact that the adoption of this ASU will have on the Company’s consolidated financial statements, as it may require additional disclosures in the notes to our condensed consolidated financial statements.

Current wording

The ASU is effective for annual periods beginning after December 15, 2024. The amendments should be applied on a prospective basis. The adoption of this ASU did not have any impact on the Company’s consolidated financial statements.