Synthetic Biologics(US:TOVX)2021-08-05 20:36markdown PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity (deficit), and cash flows, along with detailed notes explaining the company's financial position, performance, and accounting policies for the periods ended June 30, 2021, and December 31, 2020 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show a significant increase in cash and total assets from December 31, 2020, to June 30, 2021, driven by financing activities, and a shift from a stockholders' deficit to a positive equity position | Metric | June 30, 2021 (in thousands) | December 31, 2020 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $74,291 | $6,227 | | Total Current Assets | $75,632 | $7,934 | | Total Assets | $77,255 | $8,410 | | Total Liabilities | $3,524 | $3,152 | | Total Stockholders' Equity (Deficit) | $73,731 | $(7,540) | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations indicate continued net losses for both the three and six months ended June 30, 2021, and 2020, with increased research and development expenses in the recent quarter due to clinical trial activities | Metric (in thousands) | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $1,265 | $1,286 | $2,685 | $2,679 | | Research and development | $1,932 | $1,603 | $3,049 | $3,238 | | Total Operating Costs and Expenses | $3,197 | $2,889 | $5,734 | $5,917 | | Loss from Operations | $(3,197) | $(2,889) | $(5,734) | $(5,917) | | Net Loss | $(3,195) | $(2,883) | $(5,732) | $(5,873) | | Net Loss Attributable to Common Stockholders | $(3,195) | $(3,322) | $(14,654) | $(6,752) | | Net Loss Per Share - Basic and Dilutive | $(0.02) | $(0.18) | $(0.13) | $(0.38) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) The statements show a significant increase in common stock shares and additional paid-in capital during the six months ended June 30, 2021, primarily due to at-the-market offerings and warrant exercises, leading to a positive total stockholders' equity | Metric (in thousands) | December 31, 2020 | June 30, 2021 | | :-------------------- | :---------------- | :------------ | | Common Stock Shares | 29,249,925 | 132,042,538 | | Common Stock Amount | $29 | $132 | | Additional Paid-in Capital | $240,821 | $339,121 | | Accumulated Deficit | $(248,094) | $(262,748) | | Total Stockholders' Equity (Deficit) | $(7,540) | $73,731 | - Key changes during the six months ended **June 30, 2021**: * Stock issued under "at-the-market" offering: **78,685,315 shares**, contributing **$65,881 thousand** to APIC[21](index=21&type=chunk) * Warrants Exercised: **11,655,747 shares**, contributing **$8,030 thousand** to APIC[21](index=21&type=chunk) * Conversion of Series A Preferred Stock to Common: **8,996,768 shares**, contributing **$12,813 thousand** to APIC[21](index=21&type=chunk) * Conversion of Series B Preferred Stock to Common: **3,454,783 shares**, reducing Series B Preferred Stock by **$2,477 thousand** and increasing APIC by **$3,971 thousand**[21](index=21&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statements show that while operating activities continued to use cash, significant cash was provided by financing activities in the first six months of 2021, primarily from stock issuances and warrant exercises, leading to a substantial increase in cash and cash equivalents | Metric (in thousands) | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :-------------------- | :----------------------------- | :----------------------------- | | Net Cash Used in Operating Activities | $(5,924) | $(6,986) | | Net Cash Used in Investing Activities | $(14) | $0 | | Net Cash Provided by Financing Activities | $74,002 | $0 | | Net increase (decrease) in cash and cash equivalents | $68,064 | $(6,986) | | Cash and cash equivalents at the end of this period | $74,291 | $8,059 | - Noncash Financing Activities for the six months ended **June 30, 2021**: * Effect of Series A Preferred Stock price adjustment: **$7,402 thousand**[26](index=26&type=chunk) * Right of use asset from operating lease: **$1,270 thousand**[26](index=26&type=chunk) * Conversion of Series B Preferred Stock: **$2,477 thousand**[26](index=26&type=chunk) * Deemed dividends for accretion of Series B Preferred Stock discount: **$1,497 thousand**[26](index=26&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide essential context and detailed breakdowns for the condensed consolidated financial statements, covering business operations, accounting policies, specific balance sheet items, equity transactions, and commitments [1. Organization, Nature of Operations and Basis of Presentation](index=8&type=section&id=1.%20Organization,%20Nature%20of%20Operations%20and%20Basis%20of%20Presentation) Synthetic Biologics is a clinical-stage company developing therapeutics for gastrointestinal (GI) diseases, with lead candidates SYN-004 (ribaxamase) and SYN-020 (intestinal alkaline phosphatase). The financial statements are prepared in conformity with U.S. GAAP, requiring estimates and judgments - **Synthetic Biologics** is a diversified clinical-stage company focused on developing therapeutics for gastrointestinal (GI) diseases[27](index=27&type=chunk) - Lead clinical development candidates include: * **SYN-004 (ribaxamase):** Designed to degrade IV beta-lactam antibiotics in the GI tract to prevent microbiome damage, C. difficile infection (CDI), pathogenic overgrowth, antimicrobial resistance (AMR), and acute graft-versus-host-disease (aGVHD)[27](index=27&type=chunk) * **SYN-020:** A recombinant oral formulation of intestinal alkaline phosphatase (IAP) intended to treat local GI and systemic diseases[27](index=27&type=chunk) - The company is currently assessing the impact of ASU **2020-06** (Accounting for Convertible Instruments and Contracts in an Entity's Own Equity) on its consolidated financial statements, effective for annual reporting periods after **December 15, 2023**[30](index=30&type=chunk) [2. Fair Value of Financial Instruments](index=9&type=section&id=2.%20Fair%20Value%20of%20Financial%20Instruments) This note defines fair value measurement based on a three-tier hierarchy (Level 1, 2, 3 inputs) and states that the carrying amounts of the company's short-term financial instruments approximate their fair value - Fair value measurements are categorized into a three-tier hierarchy: * **Level 1 inputs:** Quoted prices (unadjusted) for identical assets or liabilities in active markets[35](index=35&type=chunk) * **Level 2 inputs:** Observable inputs other than **Level 1** quoted prices, either directly or indirectly[35](index=35&type=chunk) * **Level 3 inputs:** Unobservable inputs requiring the reporting entity to develop its own assumptions due to little or no market data[35](index=35&type=chunk) - The carrying amounts of short-term financial instruments (cash and cash equivalents, other current assets, accounts payable, accrued liabilities) approximate fair value due to their short maturity period[34](index=34&type=chunk) [3. Selected Balance Sheet Information](index=10&type=section&id=3.%20Selected%20Balance%20Sheet%20Information) This section provides detailed breakdowns of prepaid expenses and other current assets, property and equipment (net), accrued expenses, and accrued employee benefits, showing changes between June 30, 2021, and December 31, 2020 Prepaid expenses and other current assets (in thousands) | Category | June 30, 2021 | December 31, 2020 | | :-------------------------------- | :------------ | :---------------- | | Prepaid clinical research organizations | $880 | $470 | | Prepaid insurances | $280 | $639 | | Prepaid consulting, subscriptions and other expenses | $181 | $90 | | Stock sales receivable | $- | $469 | | Prepaid manufacturing expenses | $- | $39 | | **Total** | **$1,341** | **$1,707** | Property and equipment, net (in thousands) | Category | June 30, 2021 | December 31, 2020 | | :-------------------------- | :------------ | :---------------- | | Computers and office equipment | $827 | $813 | | Leasehold improvements | $94 | $439 | | Software | $11 | $11 | | Less: accumulated depreciation and amortization | $(800) | $(1,089) | | **Total** | **$132** | **$174** | Accrued expenses (in thousands) | Category | June 30, 2021 | December 31, 2020 | | :-------------------------- | :------------ | :---------------- | | Accrued clinical consulting services | $700 | $700 | | Accrued vendor payments | $92 | $225 | | Other accrued expenses | $2 | $- | | **Total** | **$794** | **$925** | **Accrued employee benefits (in thousands):** | Category | June 30, 2021 | December 31, 2020 | | :-------------------- | :------------ | :---------------- | | Accrued bonus expense | $361 | $724 | | Accrued vacation expense | $179 | $144 | | **Total** | **$540** | **$868** | [4. Stock-Based Compensation](index=11&type=section&id=4.%20Stock-Based%20Compensation) The company operates under 2007, 2010, and 2020 Stock Incentive Plans, using the Black-Scholes model to estimate the fair value of options. No options were granted in the reported periods, but stock-based compensation expense was recognized, with $483,000 remaining unrecognized as of June 30, 2021 - The company has three active Stock Incentive Plans: **2007** Stock Plan (**5,145 options outstanding**)[38](index=38&type=chunk), **2010** Stock Plan (**2,452,273 options outstanding**)[39](index=39&type=chunk), and **2020** Stock Plan (**1,540,000 options outstanding**)[40](index=40&type=chunk) - No stock options were granted during the three and six months ended **June 30, 2021**, and **2020**[42](index=42&type=chunk) Stock-based compensation expense (in thousands) | Category | Three Months Ended June 30, 2021 | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative (employees) | $34 | $40 | $67 | $79 | | Research and development (employees) | $16 | $15 | $31 | $31 | | General and administrative (consultants) | $49 | $27 | $98 | $53 | | Research and development (consultants) | $3 | $4 | $7 | $6 | - As of **June 30, 2021**, total unrecognized stock-based compensation expense related to stock options was **$483,000**, expected to be expensed through **April 2023**[51](index=51&type=chunk) [5. Stock Warrants](index=15&type=section&id=5.%20Stock%20Warrants) The company issued various stock warrants, including those from the October 2018 public offering, which had their exercise price reduced due to anti-dilution provisions. During the six months ended June 30, 2021, 11.66 million warrants were exercised for $8.0 million in cash proceeds - In **October 2018**, the company issued warrants to purchase common stock as part of a public offering. The exercise price of these warrants was reduced from **$1.38** to **$0.69 per share** on **November 16, 2020**, due to an anti-dilution clause triggered by an "at the market offering" facility[53](index=53&type=chunk)[55](index=55&type=chunk) - During the six months ended **June 30, 2021**, **11,655,747 warrants** were exercised, generating **$8.0 million** in cash proceeds. No warrants were exercised during the three months ended **June 30, 2021**[54](index=54&type=chunk) Summary of Warrant Activity | Metric | December 31, 2019 | December 31, 2020 | June 30, 2021 | | :-------------------------- | :---------------- | :---------------- | :------------ | | Number of Warrants | 18,714,999 | 18,000,713 | 6,344,966 | | Weighted Average Exercise Price | $3.24 | $0.69 | $0.69 | [6. Net Loss per Share](index=16&type=section&id=6.%20Net%20Loss%20per%20Share) This section details the calculation of basic and diluted net loss per share, noting that preferred stock dividends, conversions, and a Series A preferred stock price adjustment significantly impacted the net loss attributable to common stockholders in 2021 - Net loss attributable to common stockholders for the six months ended **June 30, 2021**, was significantly impacted by: * Exclusion of **$0.1 million** net loss attributable to non-controlling interest[58](index=58&type=chunk) * Inclusion of **$1.5 million** accretion of Series B preferred discount[58](index=58&type=chunk) * Inclusion of **$0.1 million** Series A preferred stock accrued dividends[58](index=58&type=chunk) * Inclusion of a **$7.4 million** deemed dividend from the Series A preferred stock price adjustment[58](index=58&type=chunk)[138](index=138&type=chunk) - For the three and six months ended **June 30, 2021**, all remaining Series B preferred stock were converted to common stock, so no shares were excluded from EPS computations. However, **4,804,348 shares** underlying Series B preferred stock were excluded for the three and six months ended **June 30, 2020**[58](index=58&type=chunk) - Options and warrants for common stock were excluded from net loss per common share computations for both periods as their effect was anti-dilutive[58](index=58&type=chunk) [7. Non-controlling Interest](index=18&type=section&id=7.%20Non-controlling%20Interest) The company's non-controlling interest relates to its 83% equity in SYN Biomics, Inc. The clinical study for SYN-010, co-funded with CSMC, was discontinued in September 2020, and the exclusive license agreement was terminated in November 2020 due to futility analysis results - The non-controlling interest represents the minority shareholder's **17% ownership** in the company's subsidiary, Synthetic Biomics, Inc. (**SYN Biomics**)[59](index=59&type=chunk) - The accumulated net loss attributable to the non-controlling interest was **$2.8 million** as of **June 30, 2021**, and **$2.9 million** as of **June 30, 2020**[59](index=59&type=chunk) - The **Phase 2b** clinical study of **SYN-010**, a modified-release lovastatin lactone for IBS-C, was discontinued in **September 2020** following an interim futility analysis, and the exclusive license agreement with CSMC was mutually terminated in **November 2020**[64](index=64&type=chunk)[65](index=65&type=chunk) [8. Common and Preferred Stock](index=20&type=section&id=8.%20Common%20and%20Preferred%20Stock) This note details the Series B and Series A Preferred Stock, including their issuance, conversion features, and the impact of their conversion and price adjustments on common stockholders. It also covers the company's "at-the-market" stock offering program, which generated significant proceeds in 2021 - Series B Preferred Stock was issued in **October 2018** as part of a public offering, convertible into common stock at **$1.15 per share**. Conversions resulted in deemed dividends of **$1.5 million** for the six months ended **June 30, 2021**, and **$795,000** for the six months ended **June 30, 2020**[66](index=66&type=chunk)[72](index=72&type=chunk) - Series A Convertible Preferred Stock was issued in **September 2017**. On **January 27, 2021**, the conversion price was lowered from **$18.90** to **$1.50 per share**, and the change in control put was removed to induce conversion. All outstanding Series A shares were converted to approximately **9.0 million common shares** during **Q1 2021**, resulting in a **$7.4 million** deemed dividend[73](index=73&type=chunk)[74](index=74&type=chunk)[81](index=81&type=chunk) - Through its "at-the-market" offering program with B. Riley Securities and A.G.P./Alliance Global Partners, the company sold approximately **78.7 million shares** of common stock during the six months ended **June 30, 2021**, receiving net proceeds of approximately **$66.0 million**[83](index=83&type=chunk)[84](index=84&type=chunk) [9. Related Party Transactions](index=25&type=section&id=9.%20Related%20Party%20Transactions) This note details the historical agreement with CSMC for the SYN-010 clinical study, including the issuance of company and subsidiary shares to CSMC, and the subsequent mutual termination of the license agreement and discontinuation of the study in late 2020 - In **September 2018**, the company entered an agreement with CSMC for a **Phase 2b** clinical study of **SYN-010**, issuing **50,000 common shares** and transferring **2,420,000 SYN Biomics shares** to CSMC, making CSMC a **17% owner** of **SYN Biomics**[85](index=85&type=chunk)[86](index=86&type=chunk) - The **Phase 2b** study of **SYN-010** was discontinued in **September 2020** due to an interim futility analysis, and the exclusive license agreement with CSMC was mutually terminated in **November 2020**[88](index=88&type=chunk)[89](index=89&type=chunk) - No milestone payments were owed or paid to CSMC related to this license agreement during the three and six months ended **June 30, 2021**, and **2020**[90](index=90&type=chunk) [10. Commitments and Contingencies](index=26&type=section&id=10.%20Commitments%20and%20Contingencies) This section outlines the company's operating lease commitments, including a recent facility lease renewal extending to 2027, and discusses the significant risks and uncertainties posed by the COVID-19 pandemic on its business and clinical trial timelines - The company's existing leases are classified as operating leases, with one facility lease renewed to expire in **December 2027**[91](index=91&type=chunk) Maturity Analysis of Operating Leases (in thousands of dollars) as of June 30, 2021 | Year Ending June 30 | Future Undiscounted Cash Flow | | :------------------ | :---------------------------- | | 2021 | $163 | | 2022 | $247 | | 2023 | $327 | | 2024 | $337 | | 2025 | $347 | | 2026 | $357 | | 2027 | $368 | | **Total** | **$2,146** | | Discount factor | $(524) | | Lease liability | $1,622 | | Lease liability – current | $(196) | | Lease liability – long term | $1,426 | - The **COVID-19** pandemic has caused disruptions, including the postponement of the **SYN-004** clinical trial, and continues to pose significant uncertainties regarding its impact on the company's business, clinical development, and financial condition[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, detailing its business overview, clinical and preclinical program updates, intellectual property, critical accounting policies, and a comprehensive analysis of financial performance and liquidity [Overview](index=28&type=section&id=Overview) Synthetic Biologics is a clinical-stage company focused on GI diseases with lead candidates SYN-004 and SYN-020. The company is exploring strategic options and continues to assess the potential impact of the COVID-19 pandemic on its operations and clinical trials - The company is a diversified clinical-stage company developing therapeutics for gastrointestinal (GI) diseases, with lead candidates **SYN-004 (ribaxamase)** and **SYN-020 (intestinal alkaline phosphatase)**[97](index=97&type=chunk) - Strategic options being explored include in-licensing opportunities, potential acquisitions, or other strategic transactions, while focusing on advancing **SYN-004** and **SYN-020** clinical development[98](index=98&type=chunk) - The company is continuously assessing the impact of the **COVID-19** pandemic, which could cause delays in clinical trials and adversely affect business, financial condition, and growth prospects[99](index=99&type=chunk) [Summary of Clinical and Preclinical Programs](index=29&type=section&id=Summary%20of%20Clinical%20and%20Preclinical%20Programs) This section provides updates on the company's GI and microbiome-focused pipeline, including the progress of SYN-004 (ribaxamase) and SYN-020 (oral IAP enzyme) in clinical trials, and other preclinical programs like SYN-006, SYN-007, and SYN-005 - **SYN-004 (ribaxamase):** * **Phase 1b/2a** clinical trial in allogeneic HCT recipients commenced enrollment and first patient dosed in **Q2 2021**[107](index=107&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk) * Data readout for the first cohort is anticipated in **Q4 2021**[114](index=114&type=chunk) * The study evaluates safety, tolerability, pharmacokinetics, and potential protective effects on the gut microbiome[115](index=115&type=chunk) - **SYN-020 (oral IAP enzyme):** * **Phase 1** single ascending dose (SAD) study in healthy volunteers completed enrollment, dosing, and observation in **Q2 2021**, demonstrating a favorable safety profile[108](index=108&type=chunk)[119](index=119&type=chunk) * Planning for a **Phase 1** multiple-ascending dose (MAD) study is underway, with participant screening anticipated in **Q3 2021** and topline data in **Q2 2022**[120](index=120&type=chunk) * An exclusive license option agreement with Massachusetts General Hospital (MGH) was amended to include intellectual property for inhibiting liver fibrosis in diseases like NAFLD[121](index=121&type=chunk) - **Preclinical Programs:** * **SYN-006 (carbapenemase):** Identified as a potent carbapenemase, demonstrated microbiome protection and attenuated antibiotic resistance in pig models[104](index=104&type=chunk) * **SYN-007 (ribaxamase DR):** Preclinical work ongoing for use with oral beta-lactam antibiotics, showed microbiome protection and reduced antibiotic resistance in canine studies[111](index=111&type=chunk) * **SYN-005 (monoclonal antibody therapies):** Extended half-life version of hu1B7 provided protection from pertussis in a neonatal non-human primate study[104](index=104&type=chunk) [Intellectual Property](index=37&type=section&id=Intellectual%20Property) The company maintains a robust intellectual property portfolio with over 80 U.S. and foreign patents and 65 pending applications, supporting its SYN-004 and SYN-020 programs with patent terms extending to 2031 and 2038-2040, respectively - The company has over **80 U.S. and foreign patents** and over **65 U.S. and foreign patent applications** pending[122](index=122&type=chunk) - The **SYN-004 (ribaxamase)** program is supported by U.S. and foreign patents with terms extending to at least **2031** and **2035**, covering compositions of matter, pharmaceutical compositions, and various uses[122](index=122&type=chunk) - The **SYN-020 (oral intestinal alkaline phosphatase (IAP))** program is supported by U.S. and foreign patent applications covering formulations, medical uses, and manufacturing, expected to expire between **2038** and **2040** if granted[123](index=123&type=chunk) [Critical Accounting Policies](index=37&type=section&id=Critical%20Accounting%20Policies) The company's critical accounting estimates and judgments, which involve the use of assumptions affecting reported financial amounts, remain consistent with those outlined in its 2020 Form 10-K - The condensed consolidated financial statements are prepared in conformity with U.S. GAAP, requiring the use of estimates, judgments, and assumptions[125](index=125&type=chunk) - The critical accounting estimates and the judgments and assumptions used are consistent with those described in the company's **2020** Form **10-K**[125](index=125&type=chunk) [Results of Operations (Three Months Ended June 30, 2021 and 2020)](index=37&type=section&id=Results%20of%20Operations%20(Three%20Months%20Ended%20June%2030,%202021%20and%202020)) For the three months ended June 30, 2021, general and administrative expenses slightly decreased, while research and development expenses increased due to the commencement of clinical trials for SYN-004 and SYN-020. The net loss attributable to common stockholders slightly decreased - General and administrative expenses decreased by **2%** to **$1.26 million** for **Q2 2021**, primarily due to lower legal costs and vacation expense, offset by higher insurance, audit, and registration fees[126](index=126&type=chunk) - Research and development expenses increased by **21%** to **$1.9 million** for **Q2 2021**, mainly due to increased clinical trial expenses for **SYN-004** and **SYN-020**, partially offset by lower indirect program costs[127](index=127&type=chunk) Research and Development Expenses by Therapeutic Area (in thousands) | Therapeutic Areas | June 30, 2021 | June 30, 2020 | | :---------------- | :------------ | :------------ | | SYN-020 | $697 | $- | | Ribaxamase | $332 | $40 | | SYN-010 | $- | $94 | | SYN-005 | $- | $4 | | Total direct costs | $1,029 | $138 | | Total indirect costs | $903 | $1,465 | | **Total Research and Development** | **$1,932** | **$1,603** | - Net loss attributable to common stockholders was **$3.2 million** (**$0.02 per share**) for **Q2 2021**, compared to **$3.3 million** (**$0.18 per share**) for **Q2 2020**[131](index=131&type=chunk) [Results of Operations (Six Months Ended June 30, 2021 and 2020)](index=39&type=section&id=Results%20of%20Operations%20(Six%20Months%20Ended%20June%2030,%202021%20and%202020)) For the six months ended June 30, 2021, general and administrative expenses remained stable, while research and development expenses slightly decreased due to lower indirect costs, despite increased clinical trial activity. The net loss attributable to common stockholders decreased, but was significantly impacted by preferred stock adjustments - General and administrative expenses were relatively unchanged at **$2.69 million** for **H1 2021**, with decreased legal, vacation, and travel costs offset by higher insurance, audit, and registration fees[132](index=132&type=chunk) - Research and development expenses decreased by **6%** to **$3.0 million** for **H1 2021**, primarily due to lower indirect program costs, partially offset by increased clinical trial expenses for **SYN-004** and **SYN-020**[133](index=133&type=chunk) Research and Development Expenses by Therapeutic Area (in thousands) | Therapeutic Areas | June 30, 2021 | June 30, 2020 | | :---------------- | :------------ | :------------ | | SYN-020 | $869 | $- | | Ribaxamase | $480 | $105 | | SYN-010 | $3 | $248 | | SYN-005 | $- | $28 | | Total direct costs | $1,352 | $381 | | Total indirect costs | $1,697 | $2,857 | | **Total Research and Development Expenses** | **$3,049** | **$3,238** | - Net loss attributable to common stockholders was **$5.7 million** (**$0.13 per share**) for **H1 2021**, compared to **$5.8 million** (**$0.38 per share**) for **H1 2020**. The **2021** figure includes a **$7.4 million** deemed dividend from the Series A preferred stock price adjustment[137](index=137&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) The company has a history of significant losses and negative operating cash flows, with an accumulated deficit of $262.7 million as of June 30, 2021. However, it significantly improved its cash position to $74.3 million by June 30, 2021, through $74.0 million raised from warrant exercises and "at-the-market" stock offerings, which is expected to fund operations through Q1 2023 - The company has an accumulated deficit of **$262.7 million** as of **June 30, 2021**, and expects to continue incurring losses[140](index=140&type=chunk)[162](index=162&type=chunk) - Cash and cash equivalents totaled **$74.3 million** as of **June 30, 2021**, an increase of **$68.1 million** from **December 31, 2020**[141](index=141&type=chunk) - During the six months ended **June 30, 2021**, the company raised approximately **$74.0 million** from warrant exercises (**$8.0 million**) and "at-the-market" stock offerings (**$66.0 million**)[141](index=141&type=chunk)[144](index=144&type=chunk) - Current cash and cash equivalents are believed to be sufficient to fund operations through at least the end of the first quarter of **2023**, including ongoing **Phase 1b/2a** clinical study of **SYN-004** and planned **Phase 1** SAD/MAD and **Phase 2** clinical programs for **SYN-020**[141](index=141&type=chunk)[148](index=148&type=chunk) - Additional funds will be needed for future clinical trials, especially a potential **Phase 3** program for **SYN-004**, which is not feasible without a partner given current capital constraints[149](index=149&type=chunk)[163](index=163&type=chunk) [Off-Balance Sheet Arrangements](index=43&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any material off-balance sheet arrangements during the three and six months ended June 30, 2021 - The company did not have any off-balance sheet arrangements during the three and six months ended **June 30, 2021**[151](index=151&type=chunk) [Contractual Obligations](index=43&type=section&id=Contractual%20Obligations) The company's primary contractual obligations relate to operating leases, for which ROU assets and lease liabilities are recognized. A maturity analysis of future undiscounted cash flows for these leases is provided - The company's existing leases are classified as operating leases, with Right-of-Use (ROU) assets and lease liabilities recognized based on the present value of lease payments[152](index=152&type=chunk)[153](index=153&type=chunk) Maturity Analysis of Operating Leases (in thousands of dollars) as of June 30, 2021 | Year Ending June 30 | Future Undiscounted Cash Flow | | :------------------ | :---------------------------- | | 2021 | $163 | | 2022 | $247 | | 2023 | $327 | | 2024 | $337 | | 2025 | $347 | | 2026 | $357 | | 2027 | $368 | | **Total** | **$2,146** | | Discount factor | $(524) | | Lease liability | $1,622 | | Lease liability – current | $(196) | | Lease liability – long term | $1,426 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure is primarily limited to its cash and cash equivalents, which are invested in low-risk treasury securities. Due to the short-term nature of these investments, the company does not anticipate significant impact from changes in market interest rates - The primary objective of investment activities is to preserve capital and maximize income without significant risk[154](index=154&type=chunk) - Market risk exposure is confined to cash and cash equivalents, primarily investments in treasury securities[154](index=154&type=chunk) - Due to the short-term duration and low-risk profile of investments, the company does not expect significant effects from sudden changes in market interest rates or credit conditions[154](index=154&type=chunk)[156](index=156&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures as of June 30, 2021, and reports no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=45&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management, including the Chief Executive Officer and Chief Financial Officer, concluded that the company's disclosure controls and procedures were effective as of June 30, 2021 - The company's disclosure controls and procedures were evaluated and deemed effective as of **June 30, 2021**[157](index=157&type=chunk) [Changes in Internal Control over Financial Reporting](index=45&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) There were no material changes in the company's internal control over financial reporting during the three months ended June 30, 2021 - No material changes in internal controls over financial reporting occurred during the three months ended **June 30, 2021**[158](index=158&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings that would individually or collectively have a material adverse effect on its business, operating results, financial condition, or cash flows - The company is not a party to any legal proceedings that would have a material adverse effect on its business[160](index=160&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section updates the risk factors from the 2020 Form 10-K, emphasizing the company's need for additional capital, the potential for significant stockholder dilution, and the volatility of its common stock, including risks related to NYSE American listing compliance and market fluctuations [RISKS RELATING TO OUR BUSINESS](index=46&type=section&id=RISKS%20RELATING%20TO%20OUR%20BUSINESS) The company faces significant risks related to its need for additional capital to fund operations and development programs, the potential for substantial dilution from future equity issuances, and the current capital constraints that may prevent it from initiating a Phase 3 clinical program for SYN-004 without a partner - The company has an accumulated deficit of **$262.7 million** as of **June 30, 2021**, and expects to incur additional operating losses[162](index=162&type=chunk) - Additional capital is needed to fund operations and meet current timelines; failure to obtain funding could delay or eliminate development programs[162](index=162&type=chunk)[163](index=163&type=chunk) - Raising additional funds through equity securities will likely result in significant dilution for existing stockholders, and the company's remaining authorized shares may be insufficient for future transactions[163](index=163&type=chunk)[168](index=168&type=chunk) - A **Phase 3** clinical program for **SYN-004** in a broad indication is not feasible without a partner due to significant anticipated costs and current capital constraints[163](index=163&type=chunk) [RISKS RELATING TO OUR SECURITIES](index=47&type=section&id=RISKS%20RELATING%20TO%20OUR%20SECURITIES) The market price of the company's common stock has been and may continue to be volatile, influenced by various factors including clinical trial results, regulatory developments, and general market conditions. There is also a risk of delisting from NYSE American if listing standards are not maintained, and the potential for extreme volatility due to phenomena like "short squeezes." - The market price of the company's common stock has been and may continue to be volatile, with recent fluctuations unrelated to operating performance[164](index=164&type=chunk)[166](index=166&type=chunk) - The company must maintain compliance with NYSE American listing standards, including minimum stockholders' equity and stock price, to avoid potential delisting[171](index=171&type=chunk)[172](index=172&type=chunk) - The company regained compliance with NYSE American listing standards as of **May 25, 2021**, reporting stockholders' equity of approximately **$79.6 million**[173](index=173&type=chunk)[174](index=174&type=chunk) - There is a risk of extreme stock price volatility due to phenomena like "short squeezes," which could lead to significant losses for investors purchasing shares at inflated prices[167](index=167&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=51&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not engage in any unregistered sales of equity securities during the quarter ended June 30, 2021 - No equity securities were sold in unregistered transactions during the quarter ended **June 30, 2021**[176](index=176&type=chunk) [Item 3. Defaults Upon Senior Securities](index=51&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - Not applicable[176](index=176&type=chunk) [Item 4. Mine Safety Disclosures](index=51&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period - Not applicable[177](index=177&type=chunk) [Item 5. Other Information](index=51&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the company for the reporting period - Not applicable[178](index=178&type=chunk) [Item 6. Exhibits](index=51&type=section&id=Item%206.%20Exhibits) This section refers to the Exhibit Index for a comprehensive list of all documents filed or furnished as part of this Quarterly Report on Form 10-Q - The exhibits filed or furnished as part of this Quarterly Report on Form **10-Q** are set forth on the Exhibit Index[178](index=178&type=chunk) [SIGNATURES](index=52&type=section&id=SIGNATURES) This section contains the official signatures, certifying the due authorization and filing of the Quarterly Report on Form 10-Q by Synthetic Biologics, Inc. - The report was signed by Steven A. Shallcross, Chief Executive Officer, Chief Financial Officer (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) on **August 5, 2021**[183](index=183&type=chunk) [EXHIBIT INDEX](index=53&type=section&id=EXHIBIT%20INDEX) This index provides a detailed list of all exhibits accompanying the Form 10-Q, including sales agreements, corporate governance documents, certifications, and XBRL data files - The Exhibit Index lists various documents, including the Amended and Restated At Market Issuance Sales Agreement, Certificate of Incorporation, Articles of Merger, Bylaws, and certifications (**31.1**, **32.1**), along with XBRL data files[185](index=185&type=chunk)[189](index=189&type=chunk)