Core Insights - Arquitos Capital Management reported a net return of 29.6% for Q3 2025, with year-to-date gains reaching 66.8% [1] - The firm focuses on a select group of companies and is willing to hold investments for extended periods [1] Company Highlights - Finch Therapeutics Group, Inc. (OTC:FNCH) is highlighted as a key investment, with a one-month return of -3.59% and a 52-week gain of 16.50% [2] - As of December 10, 2025, Finch Therapeutics' stock closed at $13.98, with a market capitalization of $22.449 million [2] - Finch's share price increased from $11.30 at the beginning of the year to $12.28 at the end of Q3 2025 [3] - The company won a jury trial against Ferring Pharmaceuticals in August 2024, resulting in a $30 million award and potential for enhanced damages due to willful infringement [3] Investment Perspective - Finch Therapeutics is not among the 30 most popular stocks among hedge funds, with the firm suggesting that certain AI stocks may offer better upside potential and lower downside risk [4]

Financial Performance - As of March 31, 2024, the company had an accumulated deficit of $354.3 million and expects to continue generating operating losses and negative cash flows for the foreseeable future[74]. - Total revenue for the three months ended March 31, 2024 was $0, compared to $0.1 million for the same period in 2023, primarily from collaboration revenue[88][89]. - The company incurred a net operating loss of $5.2 million for the three months ended March 31, 2024, compared to a net operating loss of $65.8 million in the same period in 2023[88]. Operating Expenses - Operating expenses for the three months ended March 31, 2024 were $5.2 million, a decrease of $60.7 million from $65.9 million in the same period in 2023, due to the Strategic Reprioritization[88]. - Research and development expenses were $0 for the three months ended March 31, 2024, down from $7.0 million in the same period in 2023[90]. - General and administrative expenses decreased to $5.2 million for the three months ended March 31, 2024, from $9.6 million in 2023, a reduction of $4.5 million[91]. - Cash used in operating activities was $4.4 million for the three months ended March 31, 2024, a decrease from $13.4 million in 2023, reflecting the impact of the Strategic Reprioritization[97]. Cash Position - As of March 31, 2024, the company had unrestricted cash and cash equivalents of $20.8 million, expected to fund operations into 2025[100]. Revenue Expectations - The company has not recognized any product revenue since inception and does not expect to progress any product candidates through clinical trials or commercial approval[95]. - The company anticipates that future revenue, if any, will be derived from enforcement and out-licensing of its intellectual property estate[95]. Growth Status - The company remains an emerging growth company until December 31, 2026, or until it meets certain revenue or market value thresholds[106]. - The company has total annual gross revenues of at least $1.235 billion to exit emerging growth status[106]. - The market value of the company's common stock held by non-affiliates must exceed $700 million to be deemed a large accelerated filer[106]. Risk Management - The company has not experienced material changes in primary risk exposures or management of market risk since the 2023 10-K[108]. - The company's market risk exposure is primarily due to interest rates[107].

Financial Performance - The company reported net losses of $74.8 million and $114.6 million for the years ended December 31, 2023 and 2022, respectively, with an accumulated deficit of $350.4 million as of December 31, 2023[247]. - Total revenue for the year ended December 31, 2023, was $0.1 million, a decrease of 88.6% from $0.9 million in 2022, primarily due to the termination of the Takeda Agreement[273]. - The net loss for 2023 was $74.8 million, an improvement from a net loss of $114.6 million in 2022[284]. - Cash used in operating activities decreased to $31.5 million in 2023 from $74.9 million in 2022, reflecting reduced operational expenses[285]. - The company anticipates continuing to incur significant losses as it seeks to realize the value of its intellectual property estate[289]. Revenue Generation - Revenue has not been generated from product sales, with future revenue expected to come primarily from collaboration and license agreements[253]. - The company does not expect to progress any product candidates through clinical trials or generate revenue from product sales in the foreseeable future[246]. - The company has no products approved for commercial sale and does not expect to generate revenue from licensed products for the foreseeable future[253]. Expenses and Cost Management - The company has significantly scaled back expenses, including reducing headcount and winding down clinical development efforts, as part of its 2023 Business Initiatives[245]. - Research and development expenses decreased by 85.6% to $7.2 million in 2023 from $52.9 million in 2022, driven by a significant scaling back of development efforts[274]. - General and administrative expenses were $26.9 million in 2023, down 25.7% from $36.2 million in 2022, mainly due to a reduction in personnel expenses[275]. - The company anticipates a decrease in general and administrative expenses due to a reduction in headcount to one full-time employee[258]. Impairment Charges - The company recognized an impairment charge of $32.9 million for in-process research and development (IPR&D) in 2023, compared to no impairment in 2022[277]. - An interim impairment test of IPR&D as of March 31, 2023, resulted in a full impairment charge of $32.9 million, as the fair value of the IPR&D asset was less than its carrying value[301]. - A full impairment charge of $13.1 million was recognized in the first quarter of 2023 for long-lived assets, including equipment and software, due to discontinuation of a clinical trial and workforce reduction[304]. - The company recorded a full goodwill impairment charge of $18.1 million due to a decline in stock price and market capitalization below net book value as of September 30, 2022[300]. Funding and Capital Requirements - The company may require additional funding to support operations and may pursue equity offerings, debt financings, or other capital sources[249]. - As of December 31, 2023, the company had unrestricted cash and cash equivalents of $25.1 million, expected to fund operations into 2025[289]. - Total lease commitments amounted to $42.4 million, with $4.8 million due within one year[290]. - The company had borrowings under its Loan Agreement totaling $15.0 million with an average interest rate of 8.71% as of December 31, 2022, but prepaid all outstanding amounts by January 25, 2023[313]. Intellectual Property and Assets - The company holds more than 113 issued U.S. and foreign patents relevant to microbiome therapeutics, including investigational candidate CP101 for preventing recurrent C. difficile infection[244]. - The company has developed a significant biorepository of strains and samples that may support future collaborations[252]. - The company evaluates long-lived assets for impairment whenever events indicate that the carrying amount may not be recoverable, measuring recoverability against future undiscounted net cash flows[302]. - The fair value of the company's IPR&D asset exceeded its carrying value as of December 31, 2022, resulting in no impairment at that time[301]. Company Classification and Reporting - The company is classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of certain exemptions and reduced reporting requirements until December 31, 2026[306][308]. - The company may present only the two most recent fiscal years of audited financial statements in its Annual Report due to its status as a smaller reporting company[309]. - The company has not entered into investments for trading or speculative purposes, maintaining a conservative investment portfolio[312].

Financial Position - As of September 30, 2023, the company has cash and cash equivalents of $28.8 million, expected to fund operations into 2025[81] - As of September 30, 2023, the company had cash and cash equivalents of $28.8 million, down from $71.0 million as of December 31, 2022[130] - The company has not engaged in trading or speculative investments, focusing instead on capital preservation with short-term maturities[130] - A one percentage point change in interest rates is not expected to materially affect the fair market value of the company's investment portfolio[130] - The company's market risk exposure is primarily due to interest rate sensitivities, which could impact financial position[129] Revenue and Expenses - The company reported no revenue for the three months ended September 30, 2023, compared to $138,000 in collaboration revenue for the same period in 2022[99][100] - Total revenue for the nine months ended September 30, 2023 was $0.1 million, down from $0.9 million in 2022, primarily due to the termination of the collaboration agreement with Takeda[107] - Total operating expenses for the three months ended September 30, 2023, were $3.78 million, a significant decrease from $40.77 million in the same period in 2022[99] - General and administrative expenses decreased to $3.7 million in Q3 2023 from $9.6 million in Q3 2022, a reduction of $5.8 million primarily due to lower professional fees and personnel expenses[102] - Research and development expenses were $0 for the three months ended September 30, 2023, down from $11.86 million in the same period in 2022, due to a strategic shift in focus[101] - Research and development expenses for the nine months ended September 30, 2023 were $7.2 million, a decrease of $34.1 million from $41.3 million in 2022, driven by a significant scaling back of development efforts[109] - Cash used in operating activities decreased to $27.8 million in 2023 from $60.6 million in 2022, reflecting reduced expenses and headcount[119] Loss and Impairment - The company recorded a net loss of $2.42 million for the three months ended September 30, 2023, compared to a net loss of $40.37 million in the same period in 2022[99] - Impairment charges recognized in 2023 included $32.9 million for IPR&D and $13.1 million for long-lived assets, with no such charges in 2022[112][113] - No goodwill impairment charge was recognized for the three months ended September 30, 2023, compared to an $18.1 million charge in the same period of 2022[103] Strategic Decisions - The company discontinued its Phase 3 clinical trial of CP101 for the prevention of recurrent CDI, reflecting a broader strategy to wind down development efforts[77][88] - The company is focusing on realizing the value of its intellectual property and other assets after scaling back its development initiatives[76] - The company does not expect to generate revenue from product sales in the near future, focusing instead on the enforcement and out-licensing of its intellectual property[117] - The company expects to finance cash needs through equity offerings, debt financings, or other capital sources, as it does not anticipate generating significant revenue in the near future[80] - The company may pursue dissolution and liquidation if unable to secure additional funding as needed[80] Other Financial Activities - The company has made payments of $5.0 million under the OpenBiome Agreement and may incur additional milestone payments up to $26.0 million[86] - Restructuring expenses for the nine months ended September 30, 2023 were $4.1 million, up from $2.2 million in 2022, due to higher costs associated with expense reduction measures[114] - The company voluntarily prepaid all outstanding amounts under the Loan Agreement on January 25, 2023, indicating a proactive approach to debt management[131] Company Classification - The company is classified as an emerging growth company and will maintain this status until December 31, 2026, or until certain revenue or market value thresholds are met[128] - The company expects to utilize the extended transition period for new or revised accounting standards while remaining an emerging growth company[127]

Financial Position - As of June 30, 2023, the company reported cash and cash equivalents of $34.1 million, expected to fund operations into 2025[83] - As of June 30, 2023, the company had cash and cash equivalents of $34.1 million, down from $71.0 million as of December 31, 2022[128] - Cash used in operating activities decreased to $22.5 million for the six months ended June 30, 2023, from $41.5 million in 2022, primarily due to reduced expenses from winding down development efforts[117] - Net cash used in financing activities was $16.2 million for the six months ended June 30, 2023, primarily due to repaying the outstanding balance under the Loan Agreement[119] Revenue and Expenses - The company generated no revenue for the three months ended June 30, 2023, compared to $0.4 million in the same period of 2022, primarily due to the termination of the Takeda Agreement[101] - Total revenue for the six months ended June 30, 2023, was $0.1 million, a decrease of $0.6 million from $0.7 million in the same period of 2022, primarily due to the termination of the collaboration agreement with Takeda[107] - Total operating expenses for the three months ended June 30, 2023, were $9.9 million, a decrease from $22.99 million in the same period of 2022[100] - General and administrative expenses increased to $8.9 million for the three months ended June 30, 2023, from $8.2 million in the same period of 2022, reflecting a $0.7 million increase primarily due to a $2.4 million rise in professional fees[103] - Research and development expenses significantly decreased to $0.2 million for the three months ended June 30, 2023, from $13.9 million in the same period of 2022, reflecting a strategic shift in focus[102] - Research and development expenses significantly decreased to $7.2 million for the six months ended June 30, 2023, from $29.5 million in 2022, reflecting a $22.3 million reduction as the company scaled back its development efforts[108] Losses and Impairments - The company recorded a net loss of $6.95 million for the three months ended June 30, 2023, compared to a net loss of $22.7 million in the same period of 2022[100] - The company expects to continue incurring significant losses as it focuses on realizing the value of its intellectual property estate and other assets[120] - Impairment charges included $32.9 million for IPR&D and $13.1 million for long-lived assets for the six months ended June 30, 2023, as certain assets were deemed to have no value[110][111] Strategic Focus - The company has no products approved for commercial sale and does not expect to generate revenue from product sales in the foreseeable future[84] - The company is focusing on realizing the value of its intellectual property and other assets after scaling back development efforts and reducing headcount[78] - The company may require additional funding to support operations as it seeks to realize value from its intellectual property estate[82] Restructuring and Management - The company incurred restructuring expenses of $0.8 million for the three months ended June 30, 2023[100] - Restructuring expenses decreased to $0.4 million for the three months ended June 30, 2023, compared to $0.9 million for the same period in 2022, due to lower costs associated with expense reduction measures[104] - The company expects general and administrative expenses to continue decreasing due to reduced headcount[91] Debt Management - On January 25, 2023, the company voluntarily prepaid all outstanding principal and interest under the Loan Agreement, indicating a proactive approach to managing debt[129] Market Position - The company will remain an emerging growth company until December 31, 2026, or until certain revenue or market value thresholds are met, including total annual gross revenues of at least $1.235 billion or a market value exceeding $700 million[126] - The company's exposure to interest rate sensitivity is primarily due to changes in U.S. bank interest rates, but it does not expect significant effects on operating results or cash flows from a one percentage point change in interest rates[128]

Financial Performance - Total revenue for the three months ended March 31, 2023, was $0.1 million, a decrease of 71% compared to $0.4 million for the same period in 2022, primarily due to the termination of the collaboration agreement with Takeda[140] - The net loss for the three months ended March 31, 2023, was $63.9 million, compared to a net loss of $24.6 million for the same period in 2022[139] - Cash and cash equivalents decreased by $29.6 million for the three months ended March 31, 2023, compared to a decrease of $26.6 million in the same period in 2022[149] - Net cash used in operating activities was $13.4 million for the three months ended March 31, 2023, a decrease from $25.6 million in the same period in 2022[149] Cash Position - As of March 31, 2023, the company has cash and cash equivalents of $41.7 million, which is expected to fund operations into 2025[118] - As of March 31, 2023, the company had cash and cash equivalents of $41.7 million, down from $71.0 million as of December 31, 2022[162] - The company believes its existing cash will fund operating expenses and capital expenditures into 2025, although this estimate is based on assumptions that may prove incorrect[154] Expenses and Cost Management - The company has significantly scaled back expenses by winding down development efforts, including liquidating certain assets and reducing headcount[107] - Research and development expenses are expected to decrease in the foreseeable future due to reduced headcount and discontinued clinical trials[128] - General and administrative expenses are also expected to decrease due to reduced headcount, while continuing to incur costs associated with being a public company[130] - Restructuring expenses amounted to $3.2 million for the three months ended March 31, 2023, compared to zero in the same period in 2022, due to expense reduction measures implemented in January 2023[145] Impairment Charges - The company recognized an impairment charge of $32.9 million for IPR&D assets in the first fiscal quarter of 2023, compared to no impairment charge in the same period in 2022[143] - An impairment charge of $13.1 million was recorded for long-lived assets in the three months ended March 31, 2023, as certain assets were deemed no longer usable following the discontinuation of the Phase 3 clinical trial in CP101[144] Strategic Partnerships and Intellectual Property - The company has a robust intellectual property estate with over 70 issued U.S. and foreign patents relevant to microbiome therapeutics[107] - The company will continue to explore opportunities for strategic partnerships and academic collaborations to realize the value of its intellectual property[112] - The company does not expect to generate revenue from product sales in the near future and plans to derive revenue from enforcement and out-licensing of its intellectual property estate[148] Clinical Trials and Development - The decision to discontinue the Phase 3 clinical trial of CP101 was made due to slower than anticipated enrollment and the ongoing unauthorized use of intellectual property[114] Financing and Revenue Generation - The company received a one-time upfront payment of $10.0 million from Takeda under the Takeda Agreement, along with $4.0 million in milestone payments[122] - The company has made payments of $5.0 million to OpenBiome related to the OpenBiome Agreement, with potential future milestone payments up to $26.0 million[125] - The company has raised approximately $177.0 million from the sale of convertible preferred stock and $14.0 million in collaboration revenue since inception[148] Market Risks and Accounting Policies - The company is exposed to market risks primarily due to interest rate sensitivities affecting its financial position[161] - The company has not experienced significant changes to its critical accounting policies from those described in its 2022 10-K filing[157] - The company has not entered into investments for trading or speculative purposes, focusing instead on capital preservation[162] Future Outlook - The company expects to continue incurring significant losses as it seeks to realize the value of its intellectual property and other assets[154] - The company will remain an emerging growth company until December 31, 2026, unless it meets certain revenue or market value thresholds[160] - There were no material changes to the company's cash requirements during the three months ended March 31, 2023[155]

Financial Performance - The company reported net losses of $114.6 million and $58.2 million for the years ended December 31, 2022, and 2021, respectively, with an accumulated deficit of $275.6 million as of December 31, 2022[245]. - Total revenue for the year ended December 31, 2022, was $0.9 million, a decrease of $17.7 million from $18.5 million in 2021, primarily due to the termination of the Takeda Agreement[266]. - General and administrative expenses rose significantly to $38.1 million in 2022, up from $21.2 million in 2021, driven by an $8.1 million increase in professional fees and a $3.6 million increase in facilities and supplies[269]. - The company recognized a goodwill impairment charge of $18.1 million in 2022 due to a decline in market conditions affecting its market capitalization[272]. - Restructuring expenses amounted to $2.4 million in 2022, reflecting costs associated with expense reduction measures implemented during the year[273]. - Net cash used in operating activities was $74.9 million in 2022, compared to $67.1 million in 2021, primarily due to a net loss of $114.6 million[276]. - Total other income, net was $0.9 million for 2022, a decrease from $1.8 million in 2021, primarily due to the forgiveness of the PPP Loan in 2021[270]. Research and Development - The company has a robust intellectual property estate with over 70 issued U.S. and foreign patents related to microbiome therapeutics[236]. - The decision to discontinue the Phase 3 clinical trial of CP101 was made in January 2023, focusing instead on realizing the value of the intellectual property estate[236]. - Research and development expenses are expected to decrease due to reduced headcount and the discontinuation of the Phase 3 clinical trial of CP101[256]. - Research and development expenses increased to $57.9 million in 2022 from $57.3 million in 2021, reflecting a $6.9 million increase in unallocated costs and a $3.9 million increase in platform-related expenses[268]. - The company discontinued its Phase 3 clinical trial of CP101 in recurrent CDI, which may lead to impairment of the IPR&D asset in Q1 2023[300]. Collaborations and Agreements - The company has entered into a collaboration agreement with the University of Minnesota for multiple investigator-sponsored clinical trials using a microbiome product candidate[242]. - The company received a one-time upfront payment of $10 million from Takeda under the Takeda Agreement, which was terminated effective November 17, 2022[251]. - The company has made payments of $5 million to OpenBiome related to the OpenBiome Agreement, with potential future milestone payments up to $26 million[254]. - The company is obligated to pay regulatory milestone payments to OpenBiome aggregating up to $6.0 million upon achieving regulatory approvals, and sales-based milestone payments of up to $20.0 million upon meeting certain net sales criteria[285]. - The company raised approximately $177.0 million from the sale of convertible preferred stock and $14.0 million in collaboration revenue from the Takeda Agreement, which was terminated in 2022[274]. Cash and Financing - The company plans to finance its cash needs through equity offerings, debt financings, or other capital sources, as it does not currently expect to generate substantial revenue[247]. - As of December 31, 2022, the company's cash and cash equivalents were $71.0 million, expected to fund operations into 2025[281]. - Cash flows from financing activities provided $14.9 million in 2022, primarily from borrowings under the Loan Agreement and stock option exercises[279]. - Borrowings under the Loan Agreement amounted to $15.0 million with an average interest rate of 8.71% as of December 31, 2022[311]. - The company voluntarily prepaid all outstanding principal and interest under the Loan Agreement on January 25, 2023[311]. Market and Risk Factors - The company does not expect to generate revenue from product sales in the near future and plans to derive revenue from enforcement and out-licensing of its intellectual property estate[274]. - The company is classified as an "emerging growth company" and a "smaller reporting company," with total annual gross revenues below $1.235 billion and market value of stock held by non-affiliates below $700.0 million[306][307]. - The company has not entered into investments for trading or speculative purposes, focusing instead on capital preservation[310]. - The company does not expect significant effects on operating results or cash flows from changes in market interest rates due to the conservative nature of its investment portfolio[310]. - The company is primarily exposed to market risk through fluctuations in foreign currency exchange rates[309]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company[308]. Obligations - Total contractual obligations amount to $68.147 million, with lease commitments of $52.582 million, loan payable of $15.0 million, and license agreements totaling $565,000[282].

CP101 for Recurrent C difficile Infection (CDI) - CDI is a debilitating disease with a significant economic impact, costing over $5 billion annually in the U S [9] - CP101 achieved a 33 8% relative risk reduction for CDI recurrence through Week 8 in the PRISM3 trial [13] - In a post-hoc analysis of PRISM3 and PRISM-EXT, 88 2% of participants were without CDI recurrence through 8 weeks following last dose of CP101 [17] - Clinical safety data for CP101 are promising, with treatment-related adverse events primarily gastrointestinal in nature and no treatment-related serious adverse events (SAEs) [18] - PRISM4, a Phase 3 trial of CP101 in recurrent CDI, has topline P4 Week 24 readout expected in H1 2024 [6, 24] Microbiome Therapeutics and Pipeline - Microbiome therapeutics have the potential to be a transformative new class of medicines [5] - Humans carry over 20 million microbial genes, compared to approximately 20 thousand human genes [5] - Finch aims to harness the full diversity and potential of the microbiome, with additional assets targeting autism and IBD [6] - Finch is exploring opportunities to further the development of FIN-524 for UC and FIN-525 for Crohn's disease through a potential strategic partnership [34] Autism Spectrum Disorder (ASD) - Open label data shows improvements in both GI and behavioral symptoms following microbiota transplantation (n=18) [39] - Randomized clinical study showed improvement in both GI and behavioral symptoms following microbiota transplantation (n=45) [41] - In the randomized clinical study, behavioral scores significantly improved at 2 months post microbiota transplantation by 10 8% [42]

Financial Performance - Total revenue for the three months ended September 30, 2022, was $0.1 million, a decrease of 98.8% compared to $11.3 million for the same period in 2021, primarily due to the termination of the collaboration agreement with Takeda [155]. - For the nine months ended September 30, 2022, total revenue was $0.9 million, a decrease of 94.9% from $17.7 million in the same period in 2021, again due to the termination of the Takeda collaboration [163]. - The company reported a net loss of $87.6 million for the nine months ended September 30, 2022, compared to a net loss of $39.1 million for the same period in 2021 [180]. - General and administrative expenses increased to $9.6 million for the three months ended September 30, 2022, up 67.1% from $5.7 million in the same period in 2021, primarily due to a $3.0 million increase in professional fees [158]. - General and administrative expenses for the nine months ended September 30, 2022, were $27.2 million, an increase of 67.9% from $16.2 million in the same period in 2021, driven by higher professional fees and other expenses [167]. - Total other income for the three months ended September 30, 2022, was $0.3 million, compared to an expense of approximately $22,000 for the same period in 2021, primarily due to sublease income [159]. - Total other income for the nine months ended September 30, 2022, was $0.2 million, a decrease of $1.6 million from $1.8 million in the same period in 2021, primarily due to the prior year's forgiveness of a PPP Loan [168]. Research and Development - Research and development expenses for the three months ended September 30, 2022, were $11.9 million, down 23.6% from $15.5 million in the same period in 2021, driven by reduced costs in the CP101 program and the suspension of the HBV and ASD programs [156][165]. - Research and development expenses for the nine months ended September 30, 2022, were $41.3 million, a slight decrease of 2.7% from $42.5 million in the same period in 2021, with significant reductions in IBD and HBV program expenses [164]. - The company anticipates topline data from its Phase 3 clinical trial of CP101, referred to as the PRISM4 trial, to be available in the first half of 2024 [127]. - The company is exploring strategic options to advance its autism spectrum disorder program after suspending efforts to initiate a Phase 1 clinical trial [128]. Cash and Funding - As of September 30, 2022, the company reported cash and cash equivalents of $85.3 million, which is expected to fund operations into the second quarter of 2024 [135]. - Cash used in operating activities for the nine months ended September 30, 2022, was $60.6 million, an increase from $53.3 million in 2021 [173][175]. - Net cash provided by financing activities for the nine months ended September 30, 2022, was $14.8 million, significantly lower than $119.0 million in 2021 [177][178]. - The company has raised approximately $177.0 million from the sale of convertible preferred stock and $14.0 million in collaboration revenue from Takeda [172]. - Cash used in investing activities was $2.1 million for the nine months ended September 30, 2022, down from $13.9 million in 2021 [176]. - Borrowings under the Term Loan totaled $15.0 million with an average interest rate of 8.65% as of September 30, 2022 [190]. Impairments and Restructuring - A goodwill impairment charge of $18.1 million was recognized for the three months ended September 30, 2022, due to a decline in market conditions affecting the company's market capitalization [160]. - For the nine months ended September 30, 2022, the company recognized a goodwill impairment charge of $18.1 million due to a decline in market conditions [169]. - Restructuring expenses for the three months ended September 30, 2022, were $1.3 million, compared to zero in the same period in 2021, reflecting costs associated with expense reduction measures [161]. - Restructuring expenses for the nine months ended September 30, 2022, were $2.2 million, compared to zero for the same period in 2021 [170]. Collaboration and Agreements - The collaboration agreement with Takeda Pharmaceutical Company Limited terminated on November 17, 2022, allowing the company to regain full rights to develop and commercialize its microbiome product candidates FIN-524 and FIN-525 [129]. - The company has received a total of $14 million from Takeda, including a one-time upfront payment of $10 million and $4 million in milestone payments [140]. - The company has made payments of $5 million to OpenBiome related to the OpenBiome Agreement, with potential future milestone payments up to $26 million [143]. - The company has not recognized any revenue related to the LMIC Agreement with OpenBiome for the three and nine months ended September 30, 2022, as there are currently no products available for sale [142].

Financial Performance - Total revenue for the three months ended June 30, 2022, was $0.4 million, a decrease of 87.3% from $2.8 million in the same period of 2021 [144]. - Collaboration revenue for the six months ended June 30, 2022, was $0.7 million, down 88.8% from $6.4 million in the same period of 2021 [152]. - Net loss for the three months ended June 30, 2022, was $22.7 million, compared to a net loss of $15.2 million in the same period of 2021, representing an increase of 49.2% [143]. - The company has incurred significant operating losses, with net losses of $47.3 million and $29.2 million for the six months ended June 30, 2022 and 2021, respectively, resulting in an accumulated deficit of $208.3 million as of June 30, 2022 [167]. Expenses - Research and development expenses for the three months ended June 30, 2022, were $13.9 million, slightly down from $14.0 million in 2021, reflecting a decrease of 0.3% [145]. - General and administrative expenses increased to $8.2 million for the three months ended June 30, 2022, up 38.8% from $5.9 million in 2021 [148]. - Total operating expenses for the six months ended June 30, 2022, were $47.9 million, an increase of 28.3% from $37.4 million in 2021 [152]. - Research and development expenses for the six months ended June 30, 2022, were $29.5 million, up 9.3% from $26.9 million in 2021 [153]. - General and administrative expenses for the six months ended June 30, 2022, were $17.6 million, an increase of 68.3% from $10.4 million in 2021 [155]. - Restructuring expenses for the three and six months ended June 30, 2022, were $0.9 million, compared to zero in the same periods of 2021, due to expense reduction measures [150][157]. Cash and Financing - As of June 30, 2022, the company reported cash and cash equivalents of $104.7 million, expected to fund operations into the first quarter of 2024 [126]. - Cash used in operating activities for the six months ended June 30, 2022 was $41.5 million, primarily due to a net loss and a net decrease in operating assets and liabilities [160]. - The company raised approximately $177.0 million from the sale of convertible preferred stock and $14.0 million in collaboration revenue from Takeda [158]. - Net cash provided by financing activities for the six months ended June 30, 2022 was $14.8 million, primarily from borrowings under the Loan Agreement [163]. - Cash used in investing activities was $1.8 million for the six months ended June 30, 2022, compared to $11.6 million in the same period of 2021 [162]. - Borrowings under the Term Loan totaled $15.0 million with an average interest rate of 8.43% as of June 30, 2022 [176]. Product Development - The company has no products approved for commercial sale and has not generated any revenue from product sales, relying primarily on collaboration and license agreements for revenue [128]. - The company is preparing to submit an IND for FIN-211 in the fourth quarter of 2022, with a Phase 1b clinical trial anticipated to follow [120]. - The company has partnered with Takeda on targeted microbiome therapeutics for inflammatory bowel disease, with ongoing reviews of development plans for TAK-524 [121]. - The company anticipates topline data from the Phase 3 PRISM4 trial for CP101 to be available in the first half of 2024 [119]. - The company has not recognized any revenue related to the LMIC Agreement with OpenBiome for the three and six months ended June 30, 2022, as there are currently no products available for sale [133]. - The company expects research and development expenses to continue increasing as clinical trials for product candidates are initiated and ongoing [137]. - The company expects expenses to increase substantially as it advances preclinical activities and clinical trials for its product candidates [167]. - The company plans to continue research and development, initiate clinical trials, and seek regulatory authorizations for its product candidates [170].