Table of Contents Delaware 87-0652870 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas 77401 (Address of principal executive offices) (Zip Code) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 Or ☐ TRANSITION REPORT PURSUANT ...

Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q2 2021 Earnings Conference Call August 13, 2021 8:30 AM ET Company Participants Peter Nielsen - President, CEO and CFO Anthony Price - SVP of Finance, Accounting and Administration Will O’Connor - Stern IR Conference Call Participants Yi Chen - H.C. Wainwright Laura Engel - Stonegate Capital Partners Operator Good morning, ladies and gentlemen and welcome to the Bio-Path Holdings' Second Quarter 2021 Earnings Conference Call. At this time, all participants are in a lis ...

Table of Contents Delaware 87-0652870 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 4710 Bellaire Boulevard, Suite 210, Bellaire, Texas 77401 (Address of principal executive offices) (Zip Code) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 Or ☐ TRANSITION REPORT PURSUANT TO S ...

Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q1 2021 Earnings Conference Call May 14, 2021 8:30 AM ET Company Participants Peter Nielsen - President, CEO and CFO Anthony Price - SVP of Finance, Accounting and Administration Will O’Connor - Stern IR Conference Call Participants Jonathan Aschoff - ROTH Capital Partners Yi Chen - H.C. Wainwright Operator Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings' First Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-onl ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 Or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __ to __ Commission file number: 001-36333 Bio-Path Holdings, Inc. (Exact name of registrant as specified in its charter) | --- | --- | --- | |--------------- ...

Bio-Path Holdings, Inc (NASDAQ:BPTH) Q4 2020 Earnings Conference Call March 10, 2021 8:30 AM ET Company Participants Will O'Connor - Stern IR Peter Nielsen - President and CEO Anthony Price - SVP of Finance, Accounting, and Administration Conference Call Participants Yi Chen - H.C. Wainwright Jonathan Aschoff - ROTH Capital Partners Laura Engle - Stonegate Capital Partners Operator Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings' Full-Year 2020 Earnings Conference Call. At this time, al ...

PART I [Business Overview](index=5&type=section&id=ITEM%201.%20BUSINESS) Bio-Path Holdings, Inc. is a clinical and preclinical stage oncology RNAi nanoparticle drug development company, leveraging its DNAbilize® technology platform to develop targeted therapies for cancer and autoimmune diseases - Bio-Path Holdings, Inc. is a clinical and preclinical stage oncology RNAi nanoparticle drug development company, focusing on targeted protein inhibition using DNAbilize® technology[16](index=16&type=chunk)[342](index=342&type=chunk)[575](index=575&type=chunk) - The DNAbilize® technology platform combines a P-ethoxy modified DNA backbone with a neutral lipid bilayer, designed to enhance antisense DNA stability and intracellular delivery while minimizing toxicity[16](index=16&type=chunk)[33](index=33&type=chunk)[342](index=342&type=chunk) - The company currently has four drug candidates: prexigebersen (BP1001), BP1002 (Liposomal Bcl-2), BP1003 (Liposomal STAT3), and prexigebersen-A (BP1001-A), targeting at least five different cancer indications[17](index=17&type=chunk)[21](index=21&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk)[28](index=28&type=chunk) - prexigebersen has entered Phase II clinical trials for AML, with a revised protocol for triple combination therapy with decitabine and venetoclax to enhance efficacy[17](index=17&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk)[39](index=39&type=chunk) - BP1002 has received IND approval and initiated Phase I clinical trials for patients with refractory/relapsed lymphoma and CLL[21](index=21&type=chunk)[41](index=41&type=chunk)[91](index=91&type=chunk) - BP1003 is undergoing IND-enabling studies as a potential treatment for pancreatic cancer, non-small cell lung cancer, and AML, with an IND application targeted for late 2021[22](index=22&type=chunk)[44](index=44&type=chunk)[349](index=349&type=chunk) - prexigebersen-A has an IND application submitted, with plans to initiate Phase I clinical trials for solid tumor patients, including ovarian and endometrial cancers[23](index=23&type=chunk)[40](index=40&type=chunk)[82](index=82&type=chunk) - The company has secured multiple US patents related to its DNAbilize® technology and specific drug combinations, protecting its platform and targeting technologies[24](index=24&type=chunk)[45](index=45&type=chunk)[98](index=98&type=chunk)[107](index=107&type=chunk) [Overview](index=5&type=section&id=Overview) Bio-Path Holdings, Inc. is a clinical and preclinical stage oncology RNAi nanoparticle drug development company, utilizing DNAbilize® technology for targeted protein inhibition - Bio-Path Holdings, Inc. is a clinical and preclinical stage oncology RNAi nanoparticle drug development company, utilizing DNAbilize® technology for targeted protein inhibition[16](index=16&type=chunk) - The DNAbilize® technology, featuring a P-ethoxy modified DNA backbone and neutral lipid bilayer, enables efficient loading and systemic delivery of antisense DNA, demonstrating good safety in animal studies and over 80 patients[16](index=16&type=chunk) [Drug Candidates](index=5&type=section&id=Drug%20Candidates) The company currently has four drug candidates: prexigebersen, BP1002, BP1003, and prexigebersen-A, for treating at least five different cancer indications - The company currently has four drug candidates: prexigebersen, BP1002, BP1003, and prexigebersen-A, for treating at least five different cancer indications[17](index=17&type=chunk)[21](index=21&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk) - prexigebersen, the lead candidate targeting Grb2 protein, has shown positive preliminary data in Phase II AML clinical trials and has been revised for triple combination therapy with decitabine and venetoclax[17](index=17&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk) - BP1002, targeting Bcl-2 protein, has received IND approval and initiated Phase I clinical trials for patients with refractory/relapsed lymphoma and CLL[21](index=21&type=chunk) - BP1003, targeting STAT3 protein, is undergoing IND-enabling studies as a potential treatment for pancreatic cancer, non-small cell lung cancer, and AML, with an IND application planned for late 2021[22](index=22&type=chunk) - prexigebersen-A, a modified prexigebersen product, has demonstrated enhanced chemotherapy efficacy in solid tumor models, with an IND application submitted and Phase I clinical trials planned for 2021[23](index=23&type=chunk) - The company has secured multiple patents related to its DNAbilize® technology, including its application in cancer, autoimmune, and infectious disease treatments, as well as P-ethoxy nucleic acid liposomal formulations and liposomal antisense oligonucleotide combination therapies[24](index=24&type=chunk) [Strategy](index=9&type=section&id=Strategy) The company's strategy is to develop its lead drug candidates prexigebersen, prexigebersen-A, BP1002, and BP1003 for multiple cancer indications, and to leverage its DNAbilize technology independently or with partners for broader disease treatments - The company's strategy is to develop its lead drug candidates prexigebersen, prexigebersen-A, BP1002, and BP1003 for multiple cancer indications, and to leverage its DNAbilize technology independently or with partners to develop treatments for a broader range of diseases[39](index=39&type=chunk) - Specific strategies include: developing prexigebersen for combination therapy in AML and MDS; developing prexigebersen-A for solid tumor treatment; developing BP1002 for lymphoma and CLL, and for AML patients relapsing on venetoclax; developing BP1003 for pancreatic cancer, NSCLC, and AML; expanding DNAbilize technology to non-cancer targets; and establishing DNAbilize as the preferred antisense drug delivery method through collaborations with pharmaceutical and academic research laboratories[39](index=39&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) [Research and Development](index=20&type=section&id=Research%20and%20Development) The company's R&D expenses primarily cover third-party clinical, preclinical, and manufacturing development activities, salaries, benefits, and stock-based compensation, with anticipated increases as the drug pipeline advances - The company's R&D expenses primarily include third-party clinical, preclinical, and manufacturing development activities, salaries, benefits, and stock-based compensation, with anticipated continuous increases as the drug pipeline advances and expands[101](index=101&type=chunk) R&D Expenses (2020 vs 2019) | Metric | 2020 (Million USD) | 2019 (Million USD) | Change (Million USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | 6.6 | 4.6 | 2.0 | 43.5 | | Non-cash Stock-based Compensation Expense | 0.1 | 0.1 | 0.0 | 0.0 | | **Total R&D Expenses** | **6.6** | **4.6** | **2.0** | **43.5** | [Manufacturing](index=20&type=section&id=Manufacturing) The company relies on third-party manufacturers for the production, packaging, and storage of its drug candidates for clinical trials and anticipates continuing this approach for commercial manufacturing if approved - The company currently does not own or operate any manufacturing facilities and plans to continue relying on third-party manufacturers for the production, packaging, and storage of drug candidates required for clinical trials in the foreseeable future[102](index=102&type=chunk) - The company has agreements with third-party manufacturers for the production of prexigebersen, BP1002, BP1003, and prexigebersen-A for their respective clinical trials[102](index=102&type=chunk) - If any drug candidate receives commercial marketing approval, the company expects to initially continue relying on third-party manufacturers for commercial production[102](index=102&type=chunk) [Sales and Marketing](index=20&type=section&id=Sales%20and%20Marketing) The company currently lacks commercial drug products and a sales and marketing organization, necessitating the establishment of such capabilities or partnerships for future commercialization - The company currently has no commercial drug products and no sales and marketing organization, requiring the establishment of sales and marketing capabilities or partnerships with third parties to commercialize approved drug candidates in the future[103](index=103&type=chunk) - For specific indications, the company may commercialize independently through specialized sales teams; for indications requiring large sales teams, it may collaborate with other companies[103](index=103&type=chunk) [Intellectual Property](index=20&type=section&id=Intellectual%20Property) The company's success largely depends on obtaining and maintaining patent protection for its drug candidates and operating without infringing third-party proprietary rights - The company's success largely depends on its ability to obtain and maintain patent protection for its drug candidates in the United States and other countries, and to operate without infringing the proprietary rights of third parties[104](index=104&type=chunk) - The company relies on trade secrets to protect its technology and safeguards proprietary know-how and processes through confidentiality agreements and intellectual property assignment agreements with partners, employees, and consultants[106](index=106&type=chunk) - The company has been granted three US patents related to DNAbilize® (No. 9,744,187, No. 10,335,428, and No. 10,898,506) and has four additional patent applications under review, covering compositions and methods of use for specific drug targets[107](index=107&type=chunk) [Employees](index=21&type=section&id=Employees) The company employs 10 full-time staff and contracts additional professionals for medical, regulatory, drug development, and administrative functions - The company currently employs **10 full-time employees** and contracts additional professionals for medical, regulatory, drug development, and administrative responsibilities[109](index=109&type=chunk) [Competition](index=21&type=section&id=Competition) The company operates in a highly competitive and rapidly changing pharmaceutical and biotechnology industry, facing numerous well-resourced competitors developing novel cancer treatments - The pharmaceutical and biotechnology industry in which the company operates is highly competitive and characterized by rapid technological change, with many large pharmaceutical and biotechnology companies, academic institutions, and others developing novel drugs for various cancers, including AML, MDS, lymphoma, ovarian cancer, and breast cancer[110](index=110&type=chunk) - Competitors may possess greater financial, technical, and human resources, more experience in drug discovery, development, manufacturing, commercialization, and regulatory approval, and may have drugs already approved or in late-stage clinical development[112](index=112&type=chunk) - Mergers and acquisitions could lead to further concentration of resources, and rapid development of competing products or technologies could render the company's drug candidates uncompetitive or obsolete before development and commercialization costs are recovered[113](index=113&type=chunk)[114](index=114&type=chunk) [Government Regulation](index=22&type=section&id=Government%20Regulation) The company's drug candidate activities, from R&D to commercialization, are extensively regulated by federal, state, local, and international government authorities, involving lengthy and costly approval processes - The research, development, testing, manufacturing, labeling, promotion, distribution, import, and export of the company's drug candidates are subject to extensive regulation by US federal, state, and local, as well as other country government authorities[115](index=115&type=chunk) - In the US, new drugs require rigorous FDA regulation, including preclinical testing, IND submission, three phases of clinical trials, NDA submission, and FDA review and approval, a process that is time-consuming and costly[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - The FDA offers Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs designed to expedite the development and review of drugs for serious or life-threatening conditions[130](index=130&type=chunk)[132](index=132&type=chunk) - The company estimates that new drug discovery to market typically takes **10 to 15 years or longer**, with its business model primarily focused on the preclinical to Phase IIa stages, aiming for later-stage development and commercialization through external licensing agreements[135](index=135&type=chunk)[136](index=136&type=chunk)[138](index=138&type=chunk) - Even after drug approval, continuous FDA regulation is required, including record-keeping, adverse event reporting, updates to safety and efficacy information, drug sampling and distribution, approval for manufacturing or labeling changes, and promotional and advertising requirements[140](index=140&type=chunk) - Non-US countries have similar regulatory approval processes, such as the EU's Clinical Trial Application (CTA) and centralized authorization procedure, with varying requirements for product licensing, pricing, and reimbursement across countries[145](index=145&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) - Drug sales are highly dependent on third-party reimbursement, and the availability and adequacy of reimbursement will impact the company's future product sales and profitability[149](index=149&type=chunk) - The Hatch-Waxman Act provides **5 years of market exclusivity** for new drugs and up to **5 years of patent term extension**; prexigebersen has received US FDA and EMA orphan drug designation for AML, granting **7 years (US) or 10 years (EU) of market exclusivity** and development incentives[154](index=154&type=chunk)[155](index=155&type=chunk) - Pharmaceutical companies are also subject to federal and state healthcare "fraud and abuse" laws and regulations, including anti-kickback and false claims laws, designed to prevent fraud, kickbacks, and other abusive practices[157](index=157&type=chunk) [Company History and Available Information](index=28&type=section&id=Company%20History%20and%20Available%20Information) The company was incorporated in Utah in 2000, became Bio-Path Holdings, Inc. via reverse merger in 2008, listed on Nasdaq in 2014, and provides SEC reports on its website - The company was incorporated in Utah in May 2000, became Bio-Path Holdings, Inc. through a reverse merger in February 2008, and was listed on the Nasdaq Capital Market on March 10, 2014 (ticker: BPTH)[158](index=158&type=chunk) - The company conducted **1:10 and 1:20 reverse stock splits** in February 2018 and January 2019, respectively[160](index=160&type=chunk) - The company's headquarters are located in Bellaire, Texas, and it provides SEC reports such as 10-K, 10-Q, 8-K, and corporate governance documents through its website[161](index=161&type=chunk) [Risk Factors](index=29&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section outlines significant investment risks, including the impact of the COVID-19 pandemic, lack of substantial revenue, ongoing operating losses, continuous need for capital, intense industry competition, and intellectual property challenges - The COVID-19 pandemic may adversely affect the company's clinical trials, patient enrollment, drug manufacturing, and regulatory approvals[168](index=168&type=chunk)[169](index=169&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) - The company has been in the clinical stage since inception, has not generated significant revenue, and has incurred continuous operating losses, with expectations of future losses and potentially never achieving profitability[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) - The company will require substantial additional capital in the future to fund clinical trials, manufacturing, and regulatory approvals; failure to raise necessary funds in a timely manner may force delays, reductions, or cancellations of drug development and commercialization plans[176](index=176&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk)[181](index=181&type=chunk) - The pharmaceutical and biotechnology industry is highly competitive, with many competitors possessing greater resources and experience; if the company cannot compete effectively, its drug candidates may lose competitiveness or become obsolete[183](index=183&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk)[188](index=188&type=chunk) - The company relies on third parties for clinical trials and drug manufacturing; if these third parties fail to perform their obligations timely and properly, it could lead to increased costs and delays, hindering regulatory approval or commercialization[254](index=254&type=chunk)[255](index=255&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk)[264](index=264&type=chunk) - Successful commercialization of the company's drug candidates depends on market acceptance, comparative safety/efficacy against other drugs, ease of administration, side effects, cost-effectiveness, and reimbursement by third-party payers[277](index=277&type=chunk)[279](index=279&type=chunk)[280](index=280&type=chunk)[281](index=281&type=chunk) - The company's patent position may be insufficient to adequately protect its drug candidates, leading to increased competition; intellectual property infringement litigation can be time-consuming and costly, potentially delaying drug market entry[287](index=287&type=chunk)[288](index=288&type=chunk)[291](index=291&type=chunk)[300](index=300&type=chunk)[302](index=302&type=chunk)[305](index=305&type=chunk) - Raising additional capital through equity or convertible debt securities may result in dilution for existing shareholders; the trading price of the company's common stock has been highly volatile and may continue to fluctuate, and insufficient liquidity may make it difficult for shareholders to sell shares at desired prices[309](index=309&type=chunk)[310](index=310&type=chunk)[312](index=312&type=chunk)[314](index=314&type=chunk)[317](index=317&type=chunk)[319](index=319&type=chunk) [Unresolved Staff Comments](index=55&type=section&id=ITEM%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments as of the report filing date - The company has no unresolved staff comments[328](index=328&type=chunk) [Properties](index=55&type=section&id=ITEM%202.%20Properties) The company leases approximately 3,000 square feet of office space and 2,100 square feet of laboratory space in Bellaire, Texas, for administrative and R&D purposes, with leases extended to 2024 and 2022 respectively - The company leases approximately **3,000 square feet of office space** in Bellaire, Texas, with the lease extended until October 31, 2024[329](index=329&type=chunk) - The company leases approximately **2,100 square feet of laboratory space** in Bellaire, Texas, with the lease extended until April 30, 2022[330](index=330&type=chunk) - The company believes its existing facilities are sufficient for current needs and anticipates additional space will be available when required in the future[331](index=331&type=chunk) [Legal Proceedings](index=55&type=section&id=ITEM%203.%20Legal%20Proceedings) The company reports no material legal proceedings as of the report filing date - The company has no material legal proceedings[332](index=332&type=chunk) [Mine Safety Disclosures](index=55&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable - Mine safety disclosures are not applicable[333](index=333&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=56&type=section&id=ITEM%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) As of March 1, 2021, the company's common stock is listed on Nasdaq Capital Market with 6,947,912 shares outstanding and approximately 214 registered shareholders, with no cash dividends paid or planned - The company's common stock is listed on the Nasdaq Capital Market under the symbol “BPTH”[336](index=336&type=chunk) Common Stock Outstanding (as of March 1, 2021) | Metric | Quantity | | :--- | :--- | | Shares Outstanding | 6,947,912 shares | | Number of Registered Shareholders | Approximately 214 | - The company has not paid any cash dividends since its inception and does not anticipate or plan to pay dividends in the foreseeable future[322](index=322&type=chunk)[337](index=337&type=chunk) - The company has not engaged in any unregistered sales of equity securities or issuer purchases of equity securities[338](index=338&type=chunk)[339](index=339&type=chunk) [ITEM 6. [Reserved]](index=56&type=section&id=ITEM%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=56&type=section&id=ITEM%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses the company's financial condition and operating results, highlighting its status as a clinical-stage biotech with no significant revenue and ongoing operating losses, driven by increased R&D expenses and a continuous need for capital - The company has not generated significant revenue since inception and has incurred continuous operating losses, with a **net loss of $10.9 million in 2020** and **$8.6 million in 2019**[353](index=353&type=chunk)[355](index=355&type=chunk)[365](index=365&type=chunk) - The company anticipates incurring substantial operating expenses in the future for clinical trials, drug manufacturing, and regulatory approvals, thus requiring significant additional capital[353](index=353&type=chunk)[383](index=383&type=chunk) - **R&D expenses in 2020 were $6.6 million**, an increase of **$2.0 million (43.5%)** from $4.6 million in 2019, primarily due to increased patient enrollment in the AML Phase II clinical trial, startup costs for BP1002 and prexigebersen-A Phase I clinical trials, increased BP1003 preclinical expenses, and higher drug material manufacturing activities[364](index=364&type=chunk) - **General and administrative expenses in 2020 were $4.3 million**, an increase of **$0.2 million (4.9%)** from $4.1 million in 2019, mainly due to higher franchise tax expenses, partially offset by reduced stock-based compensation expenses[364](index=364&type=chunk) Operating Results Overview (2020 vs 2019) | Metric | 2020 (Million USD) | 2019 (Million USD) | Change (Million USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | 6.6 | 4.6 | 2.0 | 43.5 | | General and Administrative Expenses | 4.3 | 4.1 | 0.2 | 4.9 | | Net Operating Loss | (10.9) | (8.7) | (2.2) | 25.3 | | Net Loss | (10.9) | (8.6) | (2.3) | 26.7 | | Net Loss Per Share (Basic and Diluted) | (2.83) | (3.24) | 0.41 | -12.7 | | Weighted Average Common Shares (Basic and Diluted) | 3,847 | 2,657 | 1,190 | 44.8 | - As of December 31, 2020, the company's **cash balance was $13.8 million**, a decrease of **$6.7 million** from the end of 2019; the company believes existing cash and subsequent financings will be sufficient to meet liquidity and capital expenditure needs for the next 12 months[369](index=369&type=chunk) - **Net cash outflow from operating activities was $11.0 million in 2020** and $8.4 million in 2019; **net cash inflow from financing activities was $4.3 million in 2020**, primarily from At-The-Market offerings, while in 2019, it was $27.8 million, mainly from multiple equity offerings and warrant exercises[370](index=370&type=chunk)[371](index=371&type=chunk)[372](index=372&type=chunk)[373](index=373&type=chunk) - The company raised significant capital in 2019 and early 2021 through multiple equity offerings, including underwritten offerings, registered direct offerings, and At-The-Market offerings, to support its operations and drug development[376](index=376&type=chunk)[377](index=377&type=chunk)[378](index=378&type=chunk)[380](index=380&type=chunk)[381](index=381&type=chunk)[382](index=382&type=chunk) [Overview](index=56&type=section&id=Overview) The company is a clinical and preclinical stage oncology RNAi nanoparticle drug development company, leveraging its DNAbilize® technology platform for targeted protein inhibition - The company is a clinical and preclinical stage oncology RNAi nanoparticle drug development company, utilizing its DNAbilize® technology platform, focused on targeted protein inhibition[342](index=342&type=chunk) - The company has four drug candidates: prexigebersen (AML Phase II clinical trial, triple therapy), BP1002 (lymphoma/CLL Phase I clinical trial), BP1003 (IND-enabling studies, pancreatic cancer/NSCLC/AML), and prexigebersen-A (solid tumor Phase I clinical trial)[344](index=344&type=chunk)[345](index=345&type=chunk)[346](index=346&type=chunk)[347](index=347&type=chunk)[349](index=349&type=chunk)[350](index=350&type=chunk) - The company has obtained multiple patents related to its DNAbilize® technology and actively seeks technology licensing or collaboration opportunities[351](index=351&type=chunk)[352](index=352&type=chunk) - As of December 31, 2020, the company had an **accumulated deficit of $67.2 million** and a **net loss of $10.9 million in 2020**, expecting to continue incurring losses and requiring additional financing in the future[353](index=353&type=chunk) [Financial Operations Overview](index=59&type=section&id=Financial%20Operations%20Overview) The company has not generated significant revenue, with future income dependent on successful drug development, commercialization, and various funding arrangements, while R&D expenses are expected to increase substantially - The company has not generated significant revenue, and future revenue will primarily depend on the successful development and commercialization of drug candidates, as well as product sales, third-party grants, service agreements, strategic alliances, and licensing arrangements[355](index=355&type=chunk)[356](index=356&type=chunk) - R&D expenses include salaries and benefits for research personnel, fees for third-party contract research organizations, laboratory, manufacturing organization, and consultant fees, and costs of materials used in R&D activities[357](index=357&type=chunk) - R&D expenses are expected to increase significantly with the completion of clinical trials, and the success of drug development is highly uncertain[359](index=359&type=chunk) - General and administrative expenses primarily include salaries and benefits for management and administrative personnel, legal, accounting, and other professional service fees, travel expenses, and facility-related costs[362](index=362&type=chunk) [Results of Operations](index=60&type=section&id=Results%20of%20Operations) The company reported no revenue in 2020 and 2019, with increased R&D expenses and a higher net operating loss and net loss in 2020 compared to 2019 - The company had no revenue in 2020 and 2019[363](index=363&type=chunk) R&D Expenses (2020 vs 2019) | Metric | 2020 (Million USD) | 2019 (Million USD) | Change (Million USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | 6.6 | 4.6 | 2.0 | 43.5 | | Non-cash Stock-based Compensation Expense | 0.1 | 0.1 | 0.0 | 0.0 | | **Total R&D Expenses** | **6.6** | **4.6** | **2.0** | **43.5** | General and Administrative Expenses (2020 vs 2019) | Metric | 2020 (Million USD) | 2019 (Million USD) | Change (Million USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | General and Administrative Expenses | 3.9 | 3.5 | 0.4 | 11.4 | | Non-cash Stock-based Compensation Expense | 0.5 | 0.6 | -0.1 | -16.7 | | **Total General and Administrative Expenses** | **4.3** | **4.1** | **0.2** | **4.9** | - **Net operating loss in 2020 was $10.9 million**, an increase of **$2.2 million** from $8.7 million in 2019[364](index=364&type=chunk) - **Net loss in 2020 was $10.9 million**, an increase of **$2.3 million** from $8.6 million in 2019[365](index=365&type=chunk) - **Basic and diluted net loss per share was $2.83 in 2020**, compared to $3.24 in 2019[367](index=367&type=chunk) [Liquidity and Capital Resources](index=61&type=section&id=Liquidity%20and%20Capital%20Resources) The company primarily funds operations through equity offerings and expects to require substantial additional capital, though current cash and recent financings are projected to cover the next 12 months - The company has primarily raised capital through public and private equity securities offerings since inception and expects to require substantial additional capital to support operations in the future[368](index=368&type=chunk)[383](index=383&type=chunk) Cash Balance (as of December 31) | Year | Cash Balance (Million USD) | | :--- | :--- | | 2020 | 13.8 | | 2019 | 20.4 | - The company anticipates that existing cash and subsequent financings (including a registered direct offering and warrant exercises in 2021) will be sufficient to meet liquidity and capital expenditure needs for the next 12 months[369](index=369&type=chunk) Cash Flow Overview (2020 vs 2019) | Cash Flow Type | 2020 (Million USD) | 2019 (Million USD) | | :--- | :--- | :--- | | Net Cash Outflow from Operating Activities | (11.0) | (8.4) | | Net Cash Inflow from Financing Activities | 4.3 | 27.8 | | Net (Decrease) Increase in Cash | (6.7) | 19.4 | | Ending Cash Balance | 13.8 | 20.4 | - In 2019, the company raised approximately **$26.7 million in net proceeds** through multiple equity offerings (including an underwritten offering, registered direct offering, and private placement) and **$1.1 million** from warrant exercises[373](index=373&type=chunk)[376](index=376&type=chunk)[377](index=377&type=chunk)[378](index=378&type=chunk)[380](index=380&type=chunk) - In July 2020, the company entered into an At-The-Market offering agreement with Wainwright to sell up to **$7.0 million of common stock**; as of December 31, 2020, **850,000 shares of common stock were sold** through this agreement, generating approximately **$4.3 million in net proceeds**[381](index=381&type=chunk) - In February 2021, the company raised approximately **$12.2 million in net proceeds** through a registered direct offering[382](index=382&type=chunk) [Off-Balance Sheet Arrangements](index=64&type=section&id=Off-Balance%20Sheet%20Arrangements) As of December 31, 2020, the company has no significant off-balance sheet arrangements - As of December 31, 2020, the company had no significant off-balance sheet arrangements[385](index=385&type=chunk) [Critical Accounting Policies](index=64&type=section&id=Critical%20Accounting%20Policies) Key accounting policies include expensing R&D costs as incurred, estimating clinical trial expenses based on patient costs, and recognizing prepaid items when goods or services are delivered - The company's critical accounting policies include the recognition of R&D costs, which are expensed as incurred, and prepaid items, which are recognized as expenses when the related goods are delivered or services performed[386](index=386&type=chunk) - The company estimates clinical trial expenses based on per-patient costs (including startup costs, number of patients and treatment duration, and clinical study report costs) and records accrued or prepaid expenses accordingly[387](index=387&type=chunk) R&D Expenses (2020 vs 2019) | Year | R&D Expenses (Million USD) | | :--- | :--- | | 2020 | 6.6 | | 2019 | 4.6 | [Quantitative and Qualitative Disclosures About Market Risk](index=64&type=section&id=ITEM%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable - Quantitative and qualitative disclosures about market risk are not applicable[389](index=389&type=chunk) [Financial Statements and Supplementary Data](index=64&type=section&id=ITEM%208.%20Financial%20Statements%20and%20Supplementary%20Data) The company's consolidated financial statements and the independent registered public accounting firm's report are available on pages F-1 to F-17 of this report - The company's consolidated financial statements and the report of the independent registered public accounting firm are available on pages F-1 to F-17 of this report[390](index=390&type=chunk) [Changes and Disagreements with Accountants on Accounting and Financial Disclosure](index=64&type=section&id=ITEM%209.%20Changes%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes or disagreements with accountants regarding accounting and financial disclosure - The company has no changes or disagreements with accountants regarding accounting and financial disclosure[390](index=390&type=chunk) [Controls and Procedures](index=64&type=section&id=ITEM%209A.%20Controls%20and%20Procedures) Management assessed the effectiveness of disclosure controls and internal controls over financial reporting as effective as of December 31, 2020, with no significant changes in the fourth quarter - As of December 31, 2020, the company's management, including the Chief Executive Officer and Chief Financial Officer, assessed and determined that its disclosure controls and procedures were effective[393](index=393&type=chunk) - Management reported that the company's internal control over financial reporting was effective as of December 31, 2020[396](index=396&type=chunk) - No significant changes occurred in the company's internal control over financial reporting during the fourth quarter of 2020[397](index=397&type=chunk) [Other Information](index=65&type=section&id=ITEM%209B.%20Other%20Information) The company reports no other information requiring disclosure - The company has no other information requiring disclosure[398](index=398&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=66&type=section&id=ITEM%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details the identity and background of the company's board members and executive officers, its corporate governance structure, including board independence, codes of ethics, and the responsibilities of its various committees - The company's Board of Directors consists of three independent directors (Heath W. Cleaver, Paul D. Aubert, Martina Molsbergen) and two non-independent directors (Peter H. Nielsen, Douglas P. Morris)[401](index=401&type=chunk)[408](index=408&type=chunk) - Peter H. Nielsen has served as the company's President, Chief Executive Officer, Chief Financial Officer/Treasurer, and Chairman of the Board since 2008, and is a co-founder of Bio-Path[402](index=402&type=chunk) - The company has adopted an Employee Code of Business Conduct and Ethics applicable to all employees, including executive officers, and a Board Member Code of Business Conduct and Ethics applicable to board members[409](index=409&type=chunk) - The Board of Directors has an Audit Committee, a Compensation Committee, a Nominating/Corporate Governance Committee, and a Business Development Committee, each with written charters outlining their responsibilities[411](index=411&type=chunk) - The Audit Committee is responsible for overseeing financial reporting disclosure, internal controls, audits, and financial statement review, and appoints the external auditor; Heath W. Cleaver serves as the Audit Committee Chairman and is designated as an "audit committee financial expert"[413](index=413&type=chunk)[414](index=414&type=chunk)[415](index=415&type=chunk)[416](index=416&type=chunk) - The Compensation Committee is responsible for establishing and administering compensation plans for executive officers and all employees, ensuring alignment with company performance and shareholder interests; Paul D. Aubert serves as the Compensation Committee Chairman[418](index=418&type=chunk)[419](index=419&type=chunk) - The Nominating/Corporate Governance Committee is responsible for evaluating, identifying, and recommending board candidates, and developing corporate governance guidelines; Heath W. Cleaver serves as the Nominating/Corporate Governance Committee Chairman[420](index=420&type=chunk)[421](index=421&type=chunk) - The Business Development Committee assists the Board in advising management on business development, licensing opportunities, and business collaboration initiatives; Martina Molsbergen serves as the Business Development Committee Chairman[422](index=422&type=chunk) - The company also has a Scientific Advisory Board that provides advice to management and the Board on research and development, clinical, regulatory, and commercial plans[424](index=424&type=chunk) - The company's Board of Directors is responsible for nominating board members, with the Nominating/Corporate Governance Committee assisting in identifying and reviewing potential candidates and considering shareholder recommendations[427](index=427&type=chunk)[429](index=429&type=chunk)[432](index=432&type=chunk) - The company reports that no director or executive officer has been involved in bankruptcy, criminal proceedings, or judgments or injunctions materially affecting their ability and integrity in the past ten years[433](index=433&type=chunk) - The company believes that all applicable Section 16(a) reporting requirements for executive officers, directors, and 10% beneficial owners were timely complied with as of December 31, 2020[435](index=435&type=chunk) [Executive Compensation](index=71&type=section&id=ITEM%2011.%20Executive%20Compensation) This section details the company's executive compensation plan, designed to incentivize executives through performance-linked pay, talent attraction, and alignment with shareholder interests, with Peter H. Nielsen as the sole NEO in 2020 - The company's compensation plan aims to incentivize executive officers through performance linkage, attraction and retention of talent, and alignment with shareholder interests[436](index=436&type=chunk)[439](index=439&type=chunk)[441](index=441&type=chunk)[442](index=442&type=chunk) - In 2020, the company's sole Named Executive Officer (NEO) was Peter H. Nielsen, whose compensation included base salary, an annual performance incentive bonus, and long-term equity incentives (stock options)[437](index=437&type=chunk)[443](index=443&type=chunk) - Peter H. Nielsen's **annual base salary in 2020 was $510,000**, an increase from $490,000 in 2019[456](index=456&type=chunk) - In 2020, Peter H. Nielsen received a discretionary **annual cash performance incentive bonus of $150,000**[457](index=457&type=chunk) - In 2020, Peter H. Nielsen received a stock option award totaling **100,000 shares of common stock**, which typically vest in installments over four years[458](index=458&type=chunk) Summary Compensation Table for Executive Officers (2020 vs 2019) | Name | Year | Salary ($) | Bonus ($) | Option Awards ($) | Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Peter H. Nielsen | 2020 | 510,000 | 150,000 | 427,332 | 170 | 1,087,502 | | Peter H. Nielsen | 2019 | 490,000 | — | 244,570 | 164 | 734,734 | 2020 Grants of Plan-Based Awards Table (Peter H. Nielsen) | Grant Date | Number of Securities Options () | Exercise Price ($/share) | Grant Date Fair Value ($/share) | | :--- | :--- | :--- | :--- | | March 18, 2020 | 15,000 | 3.25 | 2.83 | | June 16, 2020 | 85,000 | 5.21 | 4.53 | - Peter H. Nielsen's employment agreement stipulates that in the event of termination without cause or resignation for good reason, he is entitled to severance pay and benefits, including three months of base salary and health benefits, and accelerated vesting of unvested stock or stock options upon a change in control[475](index=475&type=chunk)[476](index=476&type=chunk)[477](index=477&type=chunk) Peter H. Nielsen Potential Severance and Benefits (Assuming Termination or Change in Control as of December 31, 2020) | Benefit | Termination Without Cause or Resignation for Good Reason ($) | Termination Without Cause or Resignation for Good Reason Following Change in Control ($) | | :--- | :--- | :--- | | Market Value of Stock Vesting | 3,750 | 3,750 | | Accrued Unused Vacation Days | 47,077 | 47,077 | | Three Months Base Salary | 127,500 | 127,500 | | Benefit Continuation | 8,816 | 17,631 | | **Total** | **187,143** | **195,958** | [DIRECTOR COMPENSATION](index=80&type=section&id=DIRECTOR%20COMPENSATION) This section discloses the compensation for non-employee directors in fiscal year 2020, including cash fees and equity incentives, with annual cash allowances, meeting fees, and stock option grants Non-Employee Director Compensation Summary Table (2020) | Name | Cash Fees ($) | Option Awards ($) | Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | | Heath W. Cleaver | 52,000 | 43,469 | — | 95,469 | | Paul D. Aubert | 42,000 | 43,469 | 750 | 86,219 | | Martina Molsbergen | 43,500 | 43,469 | — | 86,969 | | Douglas P. Morris (4) | — | 57,421 | 50,641 | 108,062 | - Non-employee directors' cash compensation includes an **annual cash retainer of $20,000**, meeting attendance fees (physical meeting **$3,000**, telephonic **$1,500 or $500**), and additional annual cash retainers for committee chairs (Audit Committee Chair **$10,000**, other committee chairs **$5,000**)[490](index=490&type=chunk)[491](index=491&type=chunk) - Non-employee directors also receive annual stock option grants of **10,000 shares of common stock each**, with exercise prices determined by the Board and options vesting monthly over one year[495](index=495&type=chunk) - Douglas P. Morris's compensation, including option awards and base salary, is earned as an employee (Director of Investor Relations) rather than as a non-employee director[485](index=485&type=chunk)[486](index=486&type=chunk)[488](index=488&type=chunk) Director Outstanding Options Summary (as of December 31, 2020) | Director | Number of Unexercised Options () | | :--- | :--- | | Heath W. Cleaver | 12,500 | | Paul D. Aubert | 12,000 | | Martina Molsbergen | 10,000 | | Douglas P. Morris | 18,640 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=83&type=section&id=ITEM%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section discloses the beneficial ownership of common stock for specified executive officers, directors, and all executive officers and directors as a group as of March 1, 2021, along with equity compensation plan information Beneficial Ownership (as of March 1, 2021) | Name of Beneficial Owner | Amount of Beneficial Ownership | Percent of Class | | :--- | :--- | :--- | | Peter H. Nielsen | 52,837 | <1% | | Douglas P. Morris | 15,792 | <1% | | Heath W. Cleaver | 12,252 | <1% | | Paul D. Aubert | 11,764 | <1% | | Martina Molsbergen | 10,000 | <1% | | All Executive Officers and Directors (as a group) | 102,645 | 1.48% | - Peter H. Nielsen's holdings include **25,823 shares held of record** and **27,014 shares exercisable within 60 days**[498](index=498&type=chunk) Equity Compensation Plan Information (as of December 31, 2020) | Plan Category | Number of Securities to be Issued () | Weighted-Average Exercise Price of Outstanding Options, Warrants ($/share) | Number of Securities Available for Future Issuance () | | :--- | :--- | :--- | :--- | | Equity Compensation Plans Approved by Security Holders | 274 | 20.57 | 403 | | Equity Compensation Plans Not Approved by Security Holders | — | — | — | - As of December 31, 2020, **402,724 shares of common stock** were available for future grants under the 2017 Stock Incentive Plan[505](index=505&type=chunk) [Certain Relationships and Related Party Transactions, and Director Independence](index=84&type=section&id=ITEM%2013.%20Certain%20Relationships%20and%20Related%20Party%20Transactions%2C%20and%20Director%20Independence) The company's policy requires the audit committee to review and approve all related party transactions, and it has indemnification agreements with certain officers and directors, with a majority of independent directors on the board and committees - The company's policy requires the Audit Committee to review and approve all related party transactions to avoid potential conflicts of interest[506](index=506&type=chunk) - The company has entered into indemnification agreements with certain executive officers and directors, providing them with indemnification under specific circumstances[510](index=510&type=chunk) - Heath W. Cleaver, Paul D. Aubert, and Martina Molsbergen are identified as independent directors[511](index=511&type=chunk) - Members of the Audit Committee, Nominating/Corporate Governance Committee, and Compensation Committee all meet the independence standards of the Nasdaq Capital Market[511](index=511&type=chunk) [Principal Accounting Fees and Services](index=85&type=section&id=ITEM%2014.%20Principal%20Accounting%20Fees%20and%20Services) The company changed its independent registered public accounting firm from BDO USA, LLP to Ernst & Young LLP (EY) in March 2020, with the audit committee pre-approving all audit and non-audit services - The company decided not to re-engage BDO USA, LLP on March 5, 2020, and appointed Ernst & Young LLP (EY) as its new independent registered public accounting firm on March 9, 2020[512](index=512&type=chunk) Fees Billed by BDO (2019 vs Jan 1 - Mar 6, 2020) | Fee Type | Jan 1 - Mar 6, 2020 (Thousand USD) | Dec 31, 2019 (Thousand USD) | | :--- | :--- | :--- | | Audit Fees | — | 225 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | All Other Fees | — | — | | **Total** | **—** | **225** | Fees Billed by EY (Mar 9 - Dec 31, 2020) | Fee Type | Mar 9 - Dec 31, 2020 (Thousand USD) | | :--- | :--- | | Audit Fees | 272 | | Audit-Related Fees | — | | Tax Fees | — | | All Other Fees | — | | **Total** | **272** | - The Audit Committee has considered the services provided by BDO and EY and believes these services are compatible with their independence for the respective periods[513](index=513&type=chunk) - The Audit Committee has not adopted any blanket pre-approval policies and procedures, instead pre-approving the provision of all audit or non-audit services[521](index=521&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=88&type=section&id=ITEM%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits included in this annual report, such as corporate charters, warrants, employment agreements, and auditor consent letters - The financial statements and information for this annual report are available on pages F-1 to F-17[524](index=524&type=chunk) - All schedules have been omitted as they are not applicable or the required information is presented in the financial statements or notes[525](index=525&type=chunk) - The exhibit list includes corporate charters, warrants, employment agreements, equity incentive plans, securities purchase agreements, At-the-Market offering agreements, auditor consent letters, and XBRL documents[526](index=526&type=chunk)[527](index=527&type=chunk)[528](index=528&type=chunk) [Form 10-K Summary](index=90&type=section&id=ITEM%2016.%20Form%2010-K%20Summary) This report does not contain a Form 10-K summary - This report does not contain a Form 10-K summary[529](index=529&type=chunk) SIGNATURES [SIGNATURES](index=91&type=section&id=SIGNATURES) This report was signed by Bio-Path Holdings, Inc.'s authorized representatives, including President, CEO, CFO, Chief Accounting Officer, and Director Peter H. Nielsen, and other directors, on March 9, 2021 - This report was signed by Peter H. Nielsen, President, Chief Executive Officer, Chief Financial Officer, Chief Accounting Officer, and Director of Bio-Path Holdings, Inc. on March 9, 2021[534](index=534&type=chunk)[535](index=535&type=chunk)[536](index=536&type=chunk) - Other directors, including Heath W. Cleaver, Paul D. Aubert, Martina Molsbergen, and Douglas P. Morris, also signed on the same date[536](index=536&type=chunk) Index to Consolidated Financial Statements [Index to Consolidated Financial Statements](index=92&type=section&id=Index%20to%20Consolidated%20Financial%20Statements) This section provides an index to the consolidated financial statements, including the independent registered public accounting firm's report, consolidated balance sheets, statements of operations, cash flows, shareholders' equity, and notes - The index to consolidated financial statements includes the report of independent registered public accounting firm, consolidated balance sheets, consolidated statements of operations, consolidated statements of cash flows, consolidated statements of shareholders' equity, and notes to consolidated financial statements[539](index=539&type=chunk) [Report of Independent Registered Public Accounting Firm](index=93&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Ernst & Young LLP issued an unqualified opinion on the company's consolidated financial statements as of December 31, 2020, highlighting accrued and prepaid R&D expenses as a key audit matter, while BDO USA, LLP issued an unqualified opinion for 2019 - Ernst & Young LLP issued an unqualified opinion on the company's consolidated financial statements as of December 31, 2020[544](index=544&type=chunk) - A key audit matter is accrued and prepaid R&D expenses, due to significant management judgment and estimation involved in their valuation; audit procedures included testing the accuracy and completeness of underlying data and evaluating key assumptions[548](index=548&type=chunk)[549](index=549&type=chunk)[550](index=550&type=chunk) - BDO USA, LLP issued an unqualified opinion on the company's consolidated financial statements as of December 31, 2019[554](index=554&type=chunk) [Consolidated Balance Sheets](index=96&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2020, the company reported total assets of $16,475 thousand, total liabilities of $1,405 thousand, and shareholders' equity of $15,070 thousand, with decreases in cash, total assets, and shareholders' equity compared to 2019 Consolidated Balance Sheet Key Data (as of December 31, in Thousand USD) | Metric | 2020 | 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash | 13,755 | 20,426 | | Prepaid Drug Product | 1,273 | 776 | | Other Current Assets | 928 | 788 | | Total Current Assets | 15,956 | 21,990 | | Net Property and Equipment | 231 | 303 | | Operating Lease Right-of-Use Assets | 288 | 367 | | **Total Assets** | **16,475** | **22,660** | | **Liabilities** | | | | Accounts Payable | 100 | 486 | | Accrued Expenses | 975 | 673 | | Current Lease Liabilities | 94 | 85 | | Total Current Liabilities | 1,169 | 1,244 | | Non-current Lease Liabilities | 236 | 330 | | **Total Liabilities** | **1,405** | **1,574** | | **Shareholders' Equity** | | | | Common Stock | 5 | 4 | | Additional Paid-in Capital | 82,286 | 77,421 | | Accumulated Deficit | (67,221) | (56,339) | | **Total Shareholders' Equity** | **15,070** | **21,086** | | **Total Liabilities and Shareholders' Equity** | **16,475** | **22,660** | - As of December 31, 2020, the **cash balance was $13,755 thousand**, a decrease from $20,426 thousand at the end of 2019[562](index=562&type=chunk) - As of December 31, 2020, the **accumulated deficit was $67,221 thousand**, an increase from $56,339 thousand at the end of 2019[562](index=562&type=chunk) [Consolidated Statements of Operations](index=97&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported no revenue in 2020 and 2019, with total operating expenses of $10,908 thousand, a net loss of $10,882 thousand, and a basic and diluted net loss per share of $2.83 in 2020 Consolidated Statements of Operations Key Data (as of December 31, in Thousand USD, except per share amounts) | Metric | 2020 | 2019 | | :--- | :--- | :--- | | R&D Expenses | 6,578 | 4,585 | | General and Administrative Expenses | 4,330 | 4,108 | | **Total Operating Expenses** | **10,908** | **8,693** | | Net Operating Loss | (10,908) | (8,693) | | Interest Income | 26 | 94 | | **Net Loss** | **(10,882)** | **(8,599)** | | Net Loss Per Share (Basic and Diluted) | (2.83) | (3.24) | | Weighted Average Common Shares (Basic and Diluted) | 3,847 | 2,657 | - **Net loss in 2020 was $10,882 thousand**, an increase of **$2,283 thousand** from $8,599 thousand in 2019[565](index=565&type=chunk) - **Basic and diluted net loss per share in 2020 was $2.83**, compared to $3.24 in 2019[565](index=565&type=chunk) [Consolidated Statements of Cash Flows](index=98&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) 2020 operating activities resulted in a net cash outflow of $10,960 thousand, primarily due to net loss, while financing activities generated a net cash inflow of $4,289 thousand, mainly from common stock sales, leading to a net cash decrease of $6,671 thousand Consolidated Statements of Cash Flows Key Data (as of December 31, in Thousand USD) | Cash Flow Type | 2020 | 2019 | | :--- | :--- | :--- | | Net Cash Outflow from Operating Activities | (10,960) | (8,361) | | Net Cash Inflow from Financing Activities | 4,289 | 27,783 | | Net (Decrease) Increase in Cash | (6,671) | 19,422 | | Cash at Beginning of Period | 20,426 | 1,004 | | **Cash at End of Period** | **13,755** | **20,426** | - **Net cash outflow from operating activities in 2020 was $10,960 thousand**, primarily composed of a **net loss of $10,882 thousand**, adjustments for **stock-based compensation expense of $577 thousand**, and **amortization of right-of-use assets of $79 thousand**[569](index=569&type=chunk) - **Net cash inflow from financing activities in 2020 was $4,289 thousand**, primarily from net proceeds from the sale of common stock[569](index=569&type=chunk) - **Net cash inflow from financing activities in 2019 was $27,783 thousand**, primarily from net proceeds of **$26,700 thousand from common stock sales** and **$1,083 thousand from warrant exercises**[569](index=569&type=chunk) [Consolidated Statements of Shareholders' Equity](index=99&type=section&id=Consolidated%20Statements%20of%20Shareholders%27%20Equity) As of December 31, 2020, total shareholders' equity was $15,070 thousand, including $5 thousand in common stock, $82,286 thousand in additional paid-in capital, and $67,221 thousand in accumulated deficit, reflecting equity issuances and net loss Consolidated Statements of Shareholders' Equity Key Data (as of December 31, in Thousand USD) | Description | Common Stock Shares | Common Stock Amount | Additional Paid-in Capital | Accumulated Deficit | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Balance at Dec 31, 2018 | 680 | 1 | 48,957 | (47,740) | 1,218 | | Net Common Stock Issuance 2019 | 2,602 | 3 | 26,697 | — | 26,700 | | Net Warrant Exercises 2019 | 410 | — | 1,083 | — | 1,083 | | Stock-based Compensation 2019 | — | — | 684 | — | 684 | | Net Loss 2019 | — | — | — | (8,599) | (8,599) | | **Balance at Dec 31, 2019** | **3,692** | **4** | **77,421** | **(56,339)** | **21,086** | | Net Common Stock Issuance 2020 | 850 | 1 | 4,288 | — | 4,289 | | Stock-based Compensation 2020 | — | — | 577 | — | 577 | | Net Loss 2020 | — | — | — | (10,882) | (10,882) | | **Balance at Dec 31, 2020** | **4,542** | **5** | **82,286** | **(67,221)** | **15,070** | - As of December 31, 2020, the **accumulated deficit increased to $67,221 thousand**[572](index=572&type=chunk) - In 2020, common stock issuance resulted in **$4,289 thousand of additional paid-in capital**, and stock-based compensation expense was **$577 thousand**[572](index=572&type=chunk) [Notes to Consolidated Financial Statements](index=100&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed notes to the consolidated financial statements, covering the company's organization, significant accounting policies, specific asset and liability accounts, equity, stock-based compensation, warrants, commitments, leases, benefit plans, income taxes, and subsequent events - The company is a clinical and preclinical stage oncology RNAi nanoparticle drug development company, utilizing its DNAbilize® technology platform, with four drug candidates currently in development[575](index=575&type=chunk) - The company has incurred continuous losses since inception, with an **accumulated deficit of $67.2 million** and a **cash balance of $13.8 million** as of December 31, 2020, and anticipates requiring substantial additional capital in the future[593](index=593&type=chunk)[594](index=594&type=chunk) - R&D costs are expensed as incurred, and prepaid amounts are recognized as expenses when related goods are delivered or services performed; clinical trial expenses are estimated based on per-patient costs[585](index=585&type=chunk)[586](index=586&type=chunk) - Stock-based compensation expense is calculated using the Black-Scholes option valuation model, with a **weighted-average fair value of $4.34 per share in 2020**, and a **total expense of $0.6 million**[611](index=611&type=chunk)[617](index=617&type=chunk) - As of December 31, 2020, the company had **$61.3 million in federal income tax net operating loss carryforwards**, with **$25.5 million available indefinitely** and the remainder expiring from 2026; a **100% valuation allowance of $16.4 million** has been recorded against deferred tax assets[629](index=629&type=chunk)[630](index=630&type=chunk)[631](index=631&type=chunk) - Subsequent to December 31, 2020, the company received approximately **$2.2 million in net proceeds from At-The-Market offerings**, **$4.1 million from warrant exercises**, and **$12.2 million from a registered direct offering in 2021**[636](index=636&type=chunk)[637](index=637&type=chunk)[638](index=638&type=chunk) [1. Organization and Business](index=100&type=section&id=1.%20Organization%20and%20Business) The company is a clinical and preclinical stage oncology RNAi nanoparticle drug development company with four drug candidates, incorporated in Utah in 2000 and reincorporated in Delaware in 2014 - The company is a clinical and preclinical stage oncology RNAi nanoparticle drug development company, utilizing its DNAbilize® technology platform, with four drug candidates currently in development[575](index=575&type=chunk) - The company was incorporated in Utah in May 2000, became Bio-Path Holdings, Inc. through a reverse merger in February 2008, and reincorporated as a Delaware corporation on December 31, 2014[576](index=576&type=chunk) - The company conducted a **1:20 reverse stock split** on January 17, 2019[577](index=577&type=chunk) - The company's operations face significant risks and uncertainties, including the need for additional funding, uncertainties in clinical trial results, and competitive risks[578](index=578&type=chunk) [2. Summary of Significant Accounting Policies](index=100&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines key accounting policies, including consolidation, cash equivalents, property and equipment depreciation, R&D expense recognition, stock-based compensation valuation, earnings per share calculation, and deferred tax asset valuation allowance - The consolidated financial statements include the accounts of Bio-Path Holdings, Inc. and its wholly-owned subsidiary, Bio-Path, Inc., with all intercompany accounts and transactions eliminated[579](index=579&type=chunk) - The company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents[579](index=579&type=chunk) - The company's cash balance is primarily held at JPMorgan Chase Bank, with approximately **$13.5 million of the cash balance uninsured by FDIC** as of December 31, 2020[580](index=580&type=chunk) - Property and equipment are stated at cost and depreciated using the straight-line method over their estimated useful lives; long-lived assets are reviewed for impairment when indicators are present[582](index=582&type=chunk)[584](index=584&type=chunk) - R&D expenses are expensed as incurred, and prepaid amounts are recognized as expenses when the related goods are delivered or services performed; clinical trial expenses are estimated based on per-patient costs[585](index=585&type=chunk)[586](index=586&type=chunk) - Stock-based compensation expense is measured using the fair value method, calculated using the Black-Scholes option valuation model[587](index=587&type=chunk) - Basic and diluted net loss per share are calculated by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding; warrants and stock options are excluded from diluted EPS calculation due to the net loss[588](index=588&type=chunk) - The preparation of financial statements involves management's estimates and judgments regarding clinical trial costs, stock-based compensation expense, warrant valuations, and deferred tax asset valuations[589](index=589&type=chunk) - Deferred income tax assets and liabilities are determined based on differences between financial reporting and tax bases, measured using enacted tax rates and laws; the company has recorded a **100% valuation allowance** against its deferred tax assets[591](index=591&type=chunk)[631](index=631&type=chunk) - The company has incurred continuous losses since inception, with an **accumulated deficit of $67.2 million** and a **cash balance of $13.8 million** as of December 31, 2020, and anticipates requiring substantial additional capital in the future[593](index=593&type=chunk)[594](index=594&type=chunk) - No new accounting pronouncements have had a significant impact on the company's consolidated financial statements recently[595](index=595&type=chunk) [3. Prepaid Drug Product](index=102&type=section&id=3.%20Prepaid%20Drug%20Product) Prepaid drug product amounts, totaling $1.3 million as of December 31, 2020, are recognized as expenses when related goods are delivered or services performed, primarily for prexigebersen and BP1002 production - Prepaid drug product amounts are recognized as expenses when the related goods are delivered or services performed; as of December 31, 2020, prepaid drug product totaled **$1.3 million**, primarily for the manufacturing and delivery of prexigebersen and BP1002[596](index=596&type=chunk) [4. Other Current Assets](index=102&type=section&id=4.%20Other%20Current%20Assets) As of December 31, 2020, other current assets include $0.9 million in prepaid expenses, primarily for BP1002 and prexigebersen-A clinical trial prepayments and prepaid insurance - As of December 31, 2020, other current assets included **$0.9 million in prepaid expenses**, primarily for prepayments related to BP1002 and prexigebersen-A clinical trials (**$0.6 million**) and prepaid insurance (**$0.3 million**)[597](index=597&type=chunk) [5. Property and Equipment](index=103&type=section&id=5.%20Property%20and%20Equipment) Property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives, with a net book value of $231 thousand as of December 31, 2020 Property and Equipment Summary (as of December 31, in Thousand USD) | Category | 2020 | 2019 | | :--- | :--- | :--- | | Leasehold Improvements | 463 | 463 | | Computer and Office Equipment | 60 | 60 | | Furniture and Fixtures | 46 | 46 | | Scientific Equipment | 460 | 460 | | **Total** | **1,029** | **1,029** | | Less: Accumulated Depreciation | (798) | (726) | | **Net Property and Equipment** | **231** | **303** | - Depreciation expense was **$0.1 million** in both 2020 and 2019[582](index=582&type=chunk) [6. Accounts Payable](index=103&type=section&id=6.%20Accounts%20Payable) Accounts payable totaled $0.1 million as of December 31, 2020, primarily for investor relations, legal, and patent fees, a decrease from $0.5 million in 2019 - As of December 31, 2020, accounts payable was **$0.1 million**, primarily comprisin

Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q3 2020 Earnings Conference Call November 13, 2020 8:30 AM ET Company Participants Will O’Connor – Stern Investor Relations Peter Nielsen – President and Chief Executive Officer Anthony Price – Senior Vice President-Finance, Accounting and Administration Conference Call Participants Boobalan Pachaiyappan – H.C. Wainwright Operator Good morning, ladies and gentlemen. Welcome to the Bio-Path Holdings’ Third Quarter 2020 Earnings Conference Call. At this time, all particip ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 Or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __ to __ Commission file number: 001-36333 Bio-Path Holdings, Inc. (Exact name of registrant as specified in its charter) | --- | --- | --- | |----------- ...

Financial Data and Key Metrics Changes - The company recorded a net loss of $2.0 million or $0.50 per share for Q2 2020, compared to a net loss of $2.5 million or $0.87 per share for Q2 2019, indicating an improvement in loss per share [38] - Research and development expenses decreased to $1.0 million in Q2 2020 from $1.5 million in Q2 2019, primarily due to the timing of activities related to the Phase II clinical trial of prexigebersen [38] - General and administrative expenses remained consistent at $1.0 million for Q2 2020 compared to the same period in 2019 [39] - Cash as of June 30, 2020, was $14.4 million, down from $20.4 million at December 31, 2019 [39] Business Line Data and Key Metrics Changes - The lead product candidate, prexigebersen, has progressed to stage two of its Phase II clinical trial for the treatment of Acute Myeloid Leukaemia (AML) [6][12] - The trial design includes cohorts for previously untreated AML, relapsed resistant AML, and patients intolerant to venetoclax, with a total of approximately 206 patients expected to be enrolled across all cohorts [58] Market Data and Key Metrics Changes - The evolving landscape for standard care in AML has prompted the company to adapt its trial design to include the combination of prexigebersen with decitabine and venetoclax, reflecting recent approvals and physician feedback [8][9] Company Strategy and Development Direction - The company aims to enhance the efficacy of frontline treatments for AML patients by adding prexigebersen to existing therapies [11][17] - Plans for BP-1002, targeting the Bcl-2 protein, and BP-1003, targeting the STAT3 protein, are underway, with expected IND filings and clinical trials in 2020 [24][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials despite challenges posed by COVID-19, noting that patient enrollment has been better than expected [45][50] - The company anticipates an increase in operating expenses as it begins dosing patients in the Phase II trial, but expects to maintain a manageable cash burn rate [59][62] Other Important Information - The company has signed up eight sites for the AML trial, with plans to expand to ten, indicating a robust infrastructure for patient enrollment [45] - The company is preparing for potential supply chain challenges but has reported good responses from patients in the relapse cohorts [49] Q&A Session Summary Question: Update on clinical trials affected by COVID-19 - Management confirmed that they have eight sites signed up for the AML trial and are working to expand to ten, with patient enrollment progressing well despite COVID-19 challenges [45][46] Question: Performance of specific AML cell lines in preclinical studies - Management acknowledged variability in responses among AML cell lines tested and indicated that not all cell lines perform uniformly [52] Question: Financial expectations regarding operating expenses - Management indicated that while operating expenses may increase due to patient costs and ongoing CRO expenses, the initial setup costs from earlier quarters would not recur, leading to a more stable expense outlook [59][62]