Tharimmune Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 7, 2024
CNTN$2.06+6.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-09.
0001493152-24-030936
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001493152-24-044063
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 76 previous paragraphs and 76 current paragraphs.
53 unchanged; 16 reworded; 6 added; 7 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 6 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
On September 11, 2024, we entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”), pursuant to which, we exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor TNF-α. Under the terms of the Intract Agreement, we licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program.
Current report
Intract Patent License Agreement
Current report
On September 11, 2024 (the “Intract Effective Date”), we entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited, (“Intract”), pursuant to which the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Under the terms of the Intract Agreement, we licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Pursuant to the Intract Agreement, Intract recieved a mid-six digit upfront paymentis eligible to receive additional payments upon an equity financing of the Company and is eligible for future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales. Under the terms of the Intract Agreement, we retain a right of first refusal to continue development and commercialization after a Phase 2 clinical trial and have the option to exercise the license to Intract’s platform for up to four additional targets. The term of the Intract Agreement expires upon the final payment obligation of the Company under the Intract Agreement. In addition, the Intract Agreement may be terminated by us at any time upon 90 days written notice to Intract. Either party may terminate the Intract Agreement if the other party materially breaches any provision of the Intract Agreement and fails to cure such breach within thirty (30) days after the breaching party receives written notice thereof. In addition, either party may terminate the Intract Agreement on written notice in the event that either party declare: (a) becomes insolvent or admits inability to pay its debts generally as they become due; (b) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within sixty (60) days; (c) is dissolved or liquidated or takes any corporate action for such purpose; (d) makes a general assignment for the benefit of creditors; or (e) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.
Current report
We signed a manufacturing agreement for clinical trial supply with regards to TH104 and the upcoming Phase 2 clinical trial on July 25, 2024 with a contract manufacturing organization located in North Carolina. The development work includes both TH104 active product and corresponding placebo batches expected to be released for clinical packaging by the end of the year.
Current report
On September 30, 2024, we entered into a nonbinding, exclusive letter of intent (the “LOI”) with Intract pursuant to which we will acquire all outstanding shares of common stock of the privately-held Intract for newly issued restricted common stock. Intract is a biopharmaceutical company incorporated in England and Wales developing disruptive delivery solutions for oral biologics. Under the terms of the LOI, following the execution of a definitive agreement and the closing of the merger, Intract shareholders will own 49% of the total equity in the combined entity, which will be named Tharimmune, Inc., with Intract becoming a wholly owned subsidiary. We believe the merger and business combination will form a best-in-class, transformative oral biologics company and the synergies between our clinical-stage assets and Intract’s delivery platform will drive pipeline growth. During the three and nine months ended September 30, 2024, we paid a $75,000 exclusivity fee to enter into the LOI agreement.
Current report
We have not recognized revenue since inception.
Removed paragraphs (7)
Previous report
We have deprioritized our previous preclinical candidate, HSB-1216, due to a strategic reprioritization of our vision to focus on therapeutics in high unmet need cancers focused on novel epitopes of certain antitumor drug targets.
Previous report
During the three and six months ended June 30, 2024, we incurred milestone fees of $150,000 in accordance with the terms of the Enkefalos LOI.
Previous report
On June 10, 2024, we reported positive results from our Phase 1 clinical trial with TH104. Results from healthy subjects demonstrated consistent pharmacokinetic (PK) profiles across buccal and intravenous routes of administration with a comparable safety and tolerability profile between routes of administration. This Phase 1 trial was a single-dose, single-center, open-label, randomized 2-way crossover study comparing 16 mg of TH104 with 1 mg intravenous nalmefene administered under fasting conditions, with a 7-day washout period between doses. Twenty healthy subjects were enrolled to complete both doses of the crossover design. All 20 subjects completed TH104 buccal dosing, while 19 of 20 subjects also completed the intravenous dosing. The primary objective was to evaluate the absolute bioavailability of TH104, as well as to assess safety and tolerability. Findings from the study indicated that the primary endpoint of the study which was absolute bioavailability (F) of TH104, or fraction (or percentage) of the administered dose absorbed into the systemic circulation compared to an equivalent intravenous dose of nalmefene, was 0.459 (45.9%). The median time to maximum concentration (Cmax) of TH104 was 2.0 hours, and mean half-life (T 1/2) as measured in the blood of subjects was 14 hours after a single buccal administration of TH104, compared to 9 hours for the 1mg intravenous dose of nalmefene. These data were consistent and within range of previous findings of nalmefene in the literature and the Company believes PK results from this Phase 1 trial show proportional kinetics consistent with published findings of oral and intravenous formulations, suggesting TH104 could be developed for once-daily dosing in a target population of moderate-to-severe chronic pruritus in PBC patients. The Phase 1 trial also demonstrated that a 16mg dose of TH104 had a comparable safety and tolerability profile to the FDA-approved 1mg dose of nalmefene intravenous formulation. Treatment emergent adverse events (TEAEs) in this study were reported in 8 subjects (40.0%) in the TH104 group and 7 subjects (36.8%) in the intravenous group. All reported TEAEs were considered mild in severity. The most frequently reported TEAE for both TH104 and intravenous treatments was dizziness (4 subjects in the TH104 group; 7 subjects in the intravenous group). TEAEs reported in at least 2 subjects in any treatment group were nausea (3 subjects in each group) and somnolence (3 subjects in each group). There were no serious adverse events reported during this study. No subjects discontinued the study due to adverse events. No subjects exhibited abnormal results for the visual examinations of the buccal mucosa pre- or post-dosing with TH104 buccal film.
Previous report
On June 17, 2024, we reported positive Type C meeting feedback from the U.S. Food and Drug Administration (FDA) for our Phase 2 clinical trial with TH104, confirming our plan to pursue a 505(b)(2) approval pathway, which permits inclusion of data from external studies when the active ingredient is already approved in the United States. The FDA also agreed that the nonclinical studies submitted to the FDA in advance of the meeting appear sufficient to support the proposed Phase 2 clinical trial. In addition, the FDA provided feedback on study design and certain recommendations regarding PBC patient inclusion, the primary endpoint to assess pruritus in these patients, and considerations for monitoring for adverse events in this patient population. Based on this interaction, we believe we have a path forward to a Phase 2 trial with TH104 in moderate-to-severe chronic pruritus in PBC patients and anticipates initiating the trial in the latter part of 2024.
Previous report
We did not recognize revenues for the three months ended June 30, 2024 and 2023.
Previous report
Deferred Offering Costs
Previous report
Deferred offering costs consisted of legal, accounting, printing, and filing fees that were capitalized and offset against the proceeds from our common stock offerings. Deferred offering costs prior to the Company’s public offering of its shares of common stock which closed on May 2, 2023 consisted of professional services incurred for filing of the Company’s Registration Statement on Form S-3 using a “shelf” registration process for additional securities offerings. These deferred offering costs were offset against the proceeds from the public offering of the Company’s common stock. At June 30, 2024, deferred offering costs of approximately $60,000 represents professional services incurred related to the At the Market Offering Agreement (the “ATM Agreement”), the Company may sell, from time to time through the applicable sales manager, shares of common stock in one or more offerings up to a total dollar amount of $1.65 million. See Notes 2 and 3 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Reworded paragraphs (16)
Previous wording
Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation with high unmet need. On November 3, 2023, we entered into a patent license agreement (the “Avior License Agreement”) with Avior Inc. d/b/a Avior Bio, LLC (“Avior”) pursuant to which we received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world, each as defined in the Avior License Agreement. See “Recent Developments” below for additional information. In February 2023, the U.S. Food and Drug Administration (“FDA”) approved an investigational new drug (“IND”) application for TH104. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or “uncontrollable itching.” With respect to TH104, we intend to first seek approval for the treatment of moderate-to-severe chronic pruritis in patients with primary biliary cholangitis (“PBC”), an orphan rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritis, and with respect to TH103, we intend to develop the product candidate and potentially file an IND.
Current wording
Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation with high unmet need. On November 3, 2023, we entered into a patent license agreement (the “Avior License Agreement”) with Avior Inc. d/b/a Avior Bio, LLC (“Avior”) pursuant to which we received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world, each as defined in the Avior License Agreement. In February 2023, the U.S. Food and Drug Administration (“FDA”) approved an investigational new drug (“IND”) application for TH104. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or “uncontrollable itching.” With respect to TH104, we intend to first seek approval for the treatment of moderate-to-severe chronic pruritis in patients with primary biliary cholangitis (“PBC”), an orphan rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritic. The Company expects to obtain topline data in a Phase 2 trial with TH104 in Q4 2025 and with respect to TH103, we intend to develop the product candidate and potentially file an IND.
Previous wording
Research and development expenses decreased by less than $0.1 million, or 3%, to approximately $1.0 million for the three months ended June 30, 2024 from $1.03 million for three months ended June 30, 2023. The decrease was primarily the result of a decrease in pre-clinical vendor expenses of approximately $0.5 million. These decreases were offset by increases in clinical trial expenses of approximately $0.2 million due to the launch of our Phase 1 clinical trial in TH104 and licensing fees of approximately $0.3 million.
Current wording
Research and development expenses increased by $1.8 million, or 367%, to $2.3 million for the three months ended September 30, 2024 from $0.5 million for the three months ended September 30, 2023. The increase was primarily the result of an increase in clinical trial expenses of approximately $0.5 million due to completion of our Phase 1 clinical trial in TH104, an increase of $1.1 million in license fees, and an increase of $0.2 million in pre-clinical expenses.
Previous wording
General and administrative expenses increased by less than $0.1 million, or 3%, to $1.4 million for the three months ended June 30, 2024 from $1.3 million for the three months ended June 30, 2023. The change in general and administrative expenses was primarily due to increases of $0.3 million in personnel expenses due to appointing a Chief Operating Officer in July 2023 and general corporate of approximately $0.1 million. These increases were offset by decreases of approximately $0.1 million in investor relations expenses, $0.1 million in professional fees expenses, and $0.1 million in insurance expense.
Current wording
General and administrative expenses increased by $0.2 million, or 17%, to $1.6 million for the three months ended September 30, 2024 from $1.4 million for the three months ended September 30, 2023. The change in general and administrative expenses was primarily due to an increase of $0.1 million in personnel costs, an increase of $0.1 million in investor relations and an increase of $0.1 million in professional fees. These increases were offset by a decrease of $0.1 million in insurance.
Previous wording
Interest expense decreased by approximately $1,300, or 20%, to $5,217 for the three months ended June 30, 2024 from $6,517 for the three months ended June 30, 2023. The decrease in interest expense was primarily related to the decrease in D&O insurance premium financing liability.
Current wording
Interest expense decreased by $487, or 14%, to $3,009 for the three months ended September 30, 2024 from $3,496 for the three months ended September 30, 2023. The decrease in interest expense was primarily related to the decrease in D&O insurance premium financing liability.
Previous wording
Interest income increased by $19,415, or 57%, to $53,614 for the three months ended June 30, 2024 from $34,199 for the three months ended June 30, 2023. The increase in interest income was primarily due to the increase in cash from the November 2023 Offering and the June 2024 PIPE Offering.
Current wording
Interest income increased by $44,277, or 156%, to $72,728 for the three months ended September 30, 2024 from $28,451 for the three months ended September 30, 2023. The increase in interest income was primarily due to the increase in cash from the November 2023 Offering and the June 2024 PIPE Offering.
Previous wording
Six Months Ended June 30, 2024 Compared to the Six Months Ended June 30, 2023
Current wording
Nine Months Ended September 30, 2024 Compared to the Nine Months Ended September 30, 2023
Previous wording
Research and development expenses decreased by less than $0.1 million, or 3%, to $2.0 million for the six months ended June 30, 2024 from $2.1 million for six months ended June 30, 2023. The decrease was primarily the result of a decrease in pre-clinical vendor expenses of approximately $0.7 million, and a decrease of less than $0.1 million in stock-based compensation expense related to a decrease in stock options vested during the period of our research and development personnel. These decreases were offset by increases in clinical trial expenses of approximately $0.4 million due to the launch of our Phase 1 clinical trial in TH104 and licensing fees of approximately $0.4 million.
Current wording
Research and development expenses increased by $1.7 million, or 68%, to $4.3 million for the nine months ended September 30, 2024 from $2.6 million for nine months ended September 30, 2023. The increase was primarily the result of an increase in clinical trial expenses of approximately $0.9 million due to completion of our Phase 1 clinical trial in TH104 and an increase of $1.5 million in license fees. These increases were offset by a decrease of $0.5 million in pre-clinical expenses and a decrease of $0.1 million in stock-based compensation expense related to our research and development personnel.
Previous wording
General and administrative expenses decreased by $0.3 million, or 10%, to $2.7 million for the six months ended June 30, 2024 from $3.0 million for the six months ended June 30, 2023. The change in general and administrative expenses was primarily due to a increases of $0.5 million in personnel expenses due to appointing a Chief Operating Officer in July 2023 and general corporate of approximately $0.2 million. These increases were offset by decreases of approximately $0.5 million in investor relations expenses, $0.3 million in professional fees expenses, $0.2 million in insurance expense, and $0.1 million in stock-based compensation expense of our general and administrative personnel.
Current wording
General and administrative expenses decreased by less than $0.1 million, or 2%, to $4.3 million for the nine months ended September 30, 2024 from $4.4 million for the nine months ended September 30, 2023. The change in general and administrative expenses was primarily due to a decrease of $0.4 million in investor relations, a decrease of $0.3 million in insurance, a decrease of $0.1 million in professional fees, and a decrease of $0.1 million in stock-based compensation expense related to our general and administrative personnel. These decreases were offset by an increase in wages of $0.7 million and an increase of $0.1 million in director remuneration.
Previous wording
Interest expense decreased by $2,738, or 22%, to $9,917 for the six months ended June 30, 2024 from $12,655 for the six months ended June 30, 2023. The decrease in interest expense was primarily related to the decrease in D&O insurance premium financing liability.
Current wording
Interest expense decreased by $3,225, or 20%, to $12,926 for the nine months ended September 30, 2024 from $16,151 for the nine months ended September 30, 2023. The decrease in interest expense was primarily related to the decrease in D&O insurance premium financing liability.
Previous wording
Interest income increased by $83,061, or 125%, to $149,508 for the six months ended June 30, 2024 from $66,447 for the six months ended June 30, 2023. The increase in interest income was primarily due to the increase in cash from the November 2023 Offering and the June 2024 PIPE Offering.
Current wording
Interest income increased by $127,338, or 134%, to $222,236 for the nine months ended September 30, 2024 from $94,898 for nine months ended September 30, 2023. The increase in interest income was primarily due to the increase in cash from the November 2023 Offering and the June 2024 PIPE Offering.
Previous wording
The accompanying condensed consolidated financial statements have been prepared on the basis that we are a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. For the six months ended June 30, 2024, we incurred operating losses of approximately $4.7 million, expended approximately $5.0 million in cash in operating activities, and had an accumulated deficit of approximately $29.3 million as of June 30, 2024. We have financed our working capital requirements through June 30, 2024 primarily through the issuance of common stock in various public and private offerings. During the year ended December 31, 2023, we received gross proceeds of approximately $13.6 million through public offerings of our common stock in the May Offering and November Offering which generated net proceeds to us of approximately $2.1 million and $9.7 million, respectively. In addition, on June 7, 2024, we filed a Registration Statement on Form S-3 with the SEC using a “shelf” registration process pursuant to which, under an At the Market Offering Agreement (the “ATM Agreement”), we may sell, from time to time through the applicable sales manager, shares of common stock in one or more offerings up to a total dollar amount of $1.65 million. Further, on June 17, 2024, we entered into a securities purchase agreement with certain accredited investors for the issuance and sale in a private placement (the “PIPE Offering”), consisting of an offering of shares of our common stock and/or pre-funded warrants to acquire shares of our common stock and warrants to acquire shares of our common stock, with net proceeds of approximately $1.8 million. See Note 3 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for details regarding these offerings.
Current wording
The accompanying condensed consolidated financial statements have been prepared on the basis that we are a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. For the nine months ended September 30, 2024, we incurred operating losses of approximately $8.6 million, expended approximately $7.9 million in cash in operating activities, and had an accumulated deficit of approximately $33.1 million as of September 30, 2024. We have financed our working capital requirements through September 30, 2024 primarily through the issuance of common stock in various public and private offerings. During the year ended December 31, 2023, we received gross proceeds of approximately $13.6 million through public offerings of our common stock in the May Offering and November Offering which generated net proceeds to us of approximately $2.1 million and $9.7 million, respectively. In addition, on June 7, 2024, we filed a Registration Statement on Form S-3 with the SEC using a “shelf” registration process pursuant to which, under an At the Market Offering Agreement (the “ATM Agreement”), we may sell, from time to time through the applicable sales manager, shares of common stock in one or more offerings up to a total dollar amount of $1.65 million. Further, on June 17, 2024, we entered into a securities purchase agreement with certain accredited investors as a part of the PIPE Offering, consisting of an offering of shares of our common stock and/or pre-funded warrants to acquire shares of our common stock and warrants to acquire shares of our common stock, with net proceeds of approximately $1.8 million. See Note 3 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for details regarding these offerings.
Previous wording
Cash Flow Activities for the Six Months Ended June 30, 2024 and 2023
Current wording
Cash Flow Activities for the Nine Months Ended September 30, 2024 and 2023
Previous wording
Cash used in operating activities for the six months ended June 30, 2024 was $5.1 million which consisted of net loss of $4.6 million, increase in prepaid and other current assets of $0.3 million and decrease in operating liabilities of $0.5 million, partially offset by non-cash stock-based compensation and stock issuance of $0.3 million.
Current wording
Cash used in operating activities for the nine months ended September 30, 2024 was $7.9 million which consisted of net loss of $8.4 million and non-cash stock-based compensation of $0.5 million, offset by increases in prepaid and other current assets of $0.4 million and operating liabilities of $0.3 million.
Previous wording
Cash used in operating activities for the six months ended June 30, 2023 was $5.0 million which consisted of net loss of $5.0 million and an increase in prepaid expenses and other current assets of $0.5 million, partially offset by an increase in operating liabilities of less than $0.1 million and non-cash stock-based compensation of $0.5 million.
Current wording
Cash used in operating activities for the nine months ended September 30, 2023 was $5.9 million which consisted of net loss of $6.8 million and an increase of $0.1 million in prepaid expenses and other current assets, partially offset by non-cash stock-based compensation of $0.6 million, $0.3 million of non-cash stock issuance pursuant to a services agreement and an increase of $0.2 million in accounts payable.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2024 was $2.0 million. The net increase in financing activities was due to proceeds from the Private Placement of $2.1 million and insurance premium financing liability of $0.4 million, offset by payments of deferred offering costs of $0.3 million and repayments of insurance premium financing liability of $0.2 million.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2024 was $1.7 million. The net increase in financing activities was due to proceeds from the PIPE Offering of $2.1 million and insurance premium financing liability of $0.4 million, offset by payments of deferred offering costs of $0.5 million and repayments of insurance premium financing liability of $0.3 million.
Previous wording
Cash provided by financing activities for the six months ended June 30, 2023 was $2.4 million. The net increase in financing activities was due to net proceeds from the May Offering of $2.65 million and proceeds from insurance premium financing liability of $0.7 million, offset by repayments of insurance premium financing liability of $0.4 million and payments of deferred offering costs of $0.6 million.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2023 was $2.1 million. The net increase in financing activities was from net cash proceeds of $2.3 million from the issuance of our common stock in connection with a public offering and $0.7 million in proceeds received from insurance premium financing liability offset by deferred offering costs of $0.3 million and $0.6 million in repayments of insurance premium financing liability.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
On June 17, 2024, we entered into a securities purchase agreement with certain accredited investors for the issuance and sale in a private placement (the “PIPE Offering”), consisting of an offering of shares of our common stock and/or pre-funded warrants to acquire shares of our common stock and warrants to acquire shares of our common stock, with net proceeds of approximately $1.8 million. See Note 3 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for details regarding these offerings.