Tharimmune Inc
For the period ended Jun 30, 2024. Filed Aug 9, 2024.
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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.
Jun 30, 2024 · Filed Aug 9, 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 2024-03-31; filed 2024-05-09.
0001493152-24-018338
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent 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 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 70 previous paragraphs and 76 current paragraphs.
51 unchanged; 12 reworded; 7 added; 7 removed; 0 previous and 6 current paragraphs rearranged.
Tables are not compared: 5 previous and 6 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 (7)
Current report
Enkefalos License Agreement
Current 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.
Current 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.
Current 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.
Current report
Interest Expense
Current report
Reverse Stock Split
Current report
On May 24, 2024, the Company effectuated an additional reverse split of shares of its common stock at a ratio of 1-for-15 pursuant to an amendment to the Company’s Certificate of Incorporation, as amended, filed with the Delaware Secretary of State and approved by the Company’s board of directors and stockholders. The par value of the Company’s common stock was not adjusted as a result of the reverse split. All issued and outstanding common stock share and per share amounts contained in the accompanying condensed consolidated financial statements have been retroactively adjusted to reflect the reverse split for all periods presented.
Removed paragraphs (7)
Previous report
The Company completed a Phase 1 clinical trial which was a pharmacokinetic bridging study in the U.S. and was designed as a single-dose, single-center, open-label, randomized 2-way crossover study with 16 mg of TH104 compared to an intravenous 1 mg dose of nalmefene administered under fasting conditions, with a 7-day washout period between doses. Sixteen subjects were planned and pre-specified to complete both doses of the crossover design per the study protocol and twenty normal healthy volunteers participated, with 19 subjects completing the study. The primary objective was to evaluate the absolute bioavailability of TH104 as well as assess safety and tolerability. Full data is expected to be achieved and reported in the second quarter of 2024. This study demonstrated that TH104 had a comparable safety and tolerability profile to the FDA approved nalmefene reference intravenous formulation. In the preliminary analysis of the completed trial safety results, all adverse events reported in the clinical trial were categorized as mild and were evenly reported between TH104 and intravenous injection. One patient did not return for the second dose of the study after a 7-day washout post the first dose which was unrelated to the study. There were no deaths, serious adverse events, or other significant adverse events reported during the entire study with events consistent with the safety profile of marketed formulations as well as those described in the literature including self-resolving nausea, dizziness, and drowsiness per previous reports with nalmefene.
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Interest Income
Previous report
Research and Development Expenses
Previous report
General and Administrative Expenses
Previous report
Interest Income
Reworded paragraphs (12)
Previous wording
As part of the ABSI Agreement, on July 26, 2023, we issued 25,107 shares of our common stock with a per share value of $9.95, representing total compensation expense of $250,000.
Current wording
As part of the ABSI Agreement, on July 26, 2023, we issued 1,674 shares of our common stock with a per share value of $149.34, representing total compensation expense of $250,000.
Previous wording
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 at March 31, 2023 consisted of professional services incurred for filing a Registration Statement on Form S-3 using a “shelf” registration process for additional securities offerings which were offset against the proceeds from Offering.
Current wording
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.
Previous wording
Interest expense decreased by $1,438, or 23%, to $4,700 for the three months ended March 31, 2024 from $6,138 for the three months ended March 31, 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 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.
Previous wording
Interest income increased by $63,646, or 197%, to $95,894 for the three months ended March 31, 2024 from $32,248 for the three months ended March 31, 2023. The increase in interest income was primarily due to the increase in cash from the November Offering.
Current 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.
Previous wording
Research and development expenses decreased by less than $0.1 million, or 2%, to $1.0 million for the three months ended March 31, 2024 from $1.0 million for three months ended March 31, 2023. The decrease was primarily the result of a decrease in pre-clinical expenses of approximately $0.3 million and as well as a decrease of approximately $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 $0.2 million due to the launch of our Phase 1 clinical trial in TH104 and licensing fees of $0.1 million.
Current 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.
Previous wording
General and administrative expenses decreased by $0.4 million, or 21%, to $1.3 million for the three months ended March 31, 2024 from $1.7 million for the three months ended March 31, 2023. The change in general and administrative expenses was primarily due to a decreases of approximately $0.4 million in investor relations expenses, $0.1 million in legal expenses, $0.1 million in insurance expense, and $0.1 million in stock-based compensation expense related to a decrease in stock options vested during the period of our general and administrative personnel. These decreases were offset by an increase of $0.3 million in personnel expenses due to appointing a Chief Operating Officer in July 2023.
Current 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.
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 three months ended March 31, 2024, we incurred operating losses of approximately $2.3 million, expended approximately $2.8 million in cash in operating activities, and had an accumulated deficit of approximately $27.0 million as of March 31, 2024. Historically we have financed our working capital requirements through March 31, 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. 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 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.
Previous wording
Cash Flow Activities for the Three Months Ended March 31, 2024 and 2023
Current wording
Cash Flow Activities for the Six Months Ended June 30, 2024 and 2023
Previous wording
Cash used in operating activities for the three months ended March 31, 2024 was $2.8 million which consisted of net loss of $2.3 million, increase in prepaid and other current assets of $0.4 million and decrease in operating liabilities of $0.3 million, partially offset by non-cash stock-based compensation of $0.2 million.
Current 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.
Previous wording
Cash used in operating activities for the three months ended March 31, 2023 was $3.5 million which consisted of net loss of $2.7 million, increase in prepaid expenses and other current assets of $0.9 million and decrease in operating liabilities of $0.2 million, partially offset by non-cash stock-based compensation of $0.3 million.
Current 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.
Previous wording
Cash provided by financing activities for the three months ended March 31, 2024 was $0.3 million. The net increase in financing activities was due to proceeds from insurance premium financing liability of $0.4 million, offset by repayments of insurance premium financing liability of $0.1 million.
Current 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.
Previous wording
Cash provided by financing activities for the three months ended March 31, 2023 was $0.5 million. The net increase in financing activities was due to proceeds from insurance premium financing liability of $0.7 million, offset by repayments of insurance premium financing liability of $0.2 million.
Current 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.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
On June 17, 2024 (the “Enkefalos Effective Date”), we signed a letter of intent (the “Enkefelos LOI”) to enter into the Enkefalos License Agreement with Enkefalos Biosciences Inc. pursuant to which we are licensing the global rights in all fields of use for the products related to the compounds knows as cyclotides to deliver HER2 antibodies across the blood-brain barrier and all associated know-how, technology, intellectual property and related information and constructs, and any associated authorized generic rights and all related assets (collectively, the “Products” referred to in this letter as ENBI-01) from Enkefalos Biosciences, Inc. Pursuant to the Enkefalos License Agreement, we paid Enkefalos an upfront license fee of $150,000 upon signing of the Enkefalos LOI and an additional $150,000 license fee to be paid 6 months after the Enkefalos Effective Date. In addition, we shall pay Enkefalos a $50,000 annual license fee and milestone payments in the aggregate amount of up to $8,500,000 upon the occurrence of various development milestones (the “Enkefalos Development Milestone Payments”). Furthermore, we shall pay Enkefalos royalties based on net sales. Such royalties range from low-single digit percentages to mid-single digit percentages with higher sales being subject to lower percentages. The Enkefalos License Agreement shall expire upon the expiration of the final payment obligation due to Enkefalos as set forth in such agreement. Upon the expiration of the Enkefalos Patent License Agreement, we shall have a fully paid, irrevocable, freely transferable and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made, use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize or have commercialized any and all Licensed Products and to practice the Licensed Technology worldwide. Pursuant to the Enkefalos License Agreement, either the Company or Enkefalos may terminate the Enkefalos License Agreement on written notice to the other party. Upon termination of the Enkefalos License Agreement, the license granted pursuant to such agreement shall terminate and all rights in the Licensed Patent Rights and Licensed Products shall revert back to Enkefalos.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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 report — wording carried from elsewhere
Six Months Ended June 30, 2024 Compared to the Six Months Ended June 30, 2023
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.