Part I [Business](index=6&type=section&id=Item%201.%20Business) Moleculin Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing treatments for hard-to-treat cancers and viruses, leveraging three core technologies licensed from MD Anderson Cancer Center - Moleculin is a clinical-stage pharmaceutical company with a pipeline focused on hard-to-treat cancers and viruses, featuring three core technologies licensed from MD Anderson Cancer Center[22](index=22&type=chunk) - The company's primary strategic focus is the development of its lead molecule, Annamycin, for the treatment of Acute Myeloid Leukemia (AML) and Soft Tissue Sarcoma (STS) lung metastases[22](index=22&type=chunk)[23](index=23&type=chunk)[30](index=30&type=chunk) Overview of Core Technologies | Technology Portfolio | Lead Candidates | Mechanism of Action | Key Features | | :--- | :--- | :--- | :--- | | **Annamycin** | Annamycin (L-Annamycin) | Next-generation anthracycline | Designed to be non-cardiotoxic and avoid multidrug resistance | | **WP1066 Portfolio** | WP1066, WP1220 | Immune/Transcription Modulators | Inhibit p-STAT3 and other oncogenic transcription factors, stimulating an immune response | | **WP1122 Portfolio** | WP1122 | Glycolysis Inhibitors | Designed to cut off the fuel supply for tumors and viruses by inhibiting glycolysis | [Our Clinical Trials](index=8&type=section&id=1.1%20Our%20Clinical%20Trials) The company has thirteen clinical trials completed, in progress, or approved, with a main focus on three ongoing Phase 1B/2 trials for Annamycin, showing key human activity across its portfolio Summary of Key Clinical Trials and Human Activity | Drug Candidate | Trial / Indication | Phase | Key Efficacy Result | | :--- | :--- | :--- | :--- | | **Annamycin** | MB-106 / 2nd Line AML | 1B/2 | **60%** CRc rate (50% CR, 10% CRi) in 2nd line subjects (n=10) | | **Annamycin** | MB-107 / STS Lung Mets | 1B/2 | Phase 2: **64%** of subjects (9 of 14) showed Stable Disease (SD) through 2+ cycles | | **WP1066** | IIT / Pediatric Brain Tumors | 1 | **1 DIPG subject** had a temporary clinical and objective response | | **WP1220** | MB-201 / CTCL | 1B | **60%** of subjects documented a Partial Response (PR) | - Across four Annamycin trials (MB-104, MB-105, MB-106, MB-107), an independent expert reviewed data from 63 of 82 subjects and reported no signs or symptoms of cardiotoxicity[44](index=44&type=chunk) [Annamycin Program](index=12&type=section&id=1.2%20Annamycin%20Program) Annamycin, the company's lead drug candidate, is a next-generation anthracycline designed to overcome cardiotoxicity and multidrug resistance, holding Orphan Drug and Fast Track Designations for AML and STS - Annamycin has been granted Orphan Drug Designation (ODD) and Fast Track Designation (FTD) by the FDA for both AML and soft tissue sarcoma[48](index=48&type=chunk) Annamycin AML Clinical Trial Efficacy (MB-106 as of March 19, 2024) | Population | N (Evaluable) | CRc Rate | CR Rate | CRi Rate | | :--- | :--- | :--- | :--- | :--- | | **All Lines** | 18 | **39%** | **33%** | **6%** | | **As 2nd Line Only** | 10 | **60%** | **50%** | **10%** | Annamycin STS Lung Metastases Clinical Trial (MB-107) PFS | Population | N | Median PFS (months) | | :--- | :--- | :--- | | **All Subjects** | 32 | **2.3** | | **Phase 1B Subjects** | 15 | **2.6** | | **Subjects at ≤330 mg/m² & <2 Prior Therapies** | 9 | **3.1** | - To date, **62 of 82 subjects** have been treated above the FDA's lifetime maximum anthracycline dose limit, with one subject reaching approximately **six times** the limit, all with no evidence of cardiotoxicity[55](index=55&type=chunk) [WP1066 Portfolio Program](index=24&type=section&id=1.3%20WP1066%20Portfolio%20Program) The WP1066 portfolio comprises immune/transcription modulators that inhibit oncogenic pathways and boost immune response, with WP1066 showing clinical activity in DIPG and WP1220 in CTCL - The WP1066 portfolio represents a novel class of agents that inhibit multiple oncogenic transcription factors (p-STAT3, c-Myc, HIF-1α) and also boost immune response by inhibiting TRegs[115](index=115&type=chunk)[116](index=116&type=chunk) - In a physician-sponsored trial, WP1066 demonstrated both a clinical and objective response in a subject with diffuse intrinsic pontine glioma (DIPG)[49](index=49&type=chunk)[130](index=130&type=chunk) - A topical formulation, WP1220, showed a **60% partial response rate** in a trial for cutaneous T-cell lymphoma (CTCL), with **100% of subjects** showing clinical benefit[49](index=49&type=chunk)[136](index=136&type=chunk) - The company is developing an intravenous (IV) formulation for the WP1066 portfolio to overcome the undesirable taste and potentially suboptimal bioavailability of the current oral formulation[138](index=138&type=chunk) [WP1122 Portfolio Program](index=28&type=section&id=1.4%20WP1122%20Portfolio%20Program) The WP1122 portfolio targets glycolysis inhibition, with lead candidate WP1122 completing a Phase 1a study and establishing a Recommended Phase 2 Dose, though further development is contingent on external funding - WP1122 is a prodrug of 2-DG designed to inhibit glycolysis, a critical energy source for highly dependent tumors and viruses[139](index=139&type=chunk)[142](index=142&type=chunk) - A Phase 1a clinical trial was successfully completed, establishing a maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of **32 mg/kg daily**, which can advance future antiviral and oncology studies[146](index=146&type=chunk)[148](index=148&type=chunk) - The company has an active IND for WP1122 for the treatment of glioblastoma (GBM), but further clinical development in oncology and virology is contingent on securing external funding[149](index=149&type=chunk)[150](index=150&type=chunk) [Intellectual Property and Government Regulation](index=32&type=section&id=1.5%20Intellectual%20Property%20and%20Government%20Regulation) The company's intellectual property is secured through exclusive licenses from MD Anderson, complemented by various beneficial FDA designations, while its operations are subject to extensive government regulation across the drug development lifecycle - The company has secured worldwide, exclusive licenses from MD Anderson for the patents and technology related to its drug candidates[158](index=158&type=chunk) Key FDA Designations | Drug Candidate | Orphan Drug Designation (ODD) | Fast Track Designation (FTD) | Rare Pediatric Disease (RPD) Program | | :--- | :--- | :--- | :--- | | **Annamycin** | AML, Soft Tissue Sarcoma | AML, Soft Tissue Sarcoma | No | | **WP1066** | GBM | No | Yes (DIPG, etc.) | | **WP1122** | GBM | Yes - GBM | No | - The company's operations are subject to extensive regulation by the FDA and other global authorities, covering the entire product lifecycle from preclinical testing and clinical trials (GCP) to manufacturing (cGMP) and post-approval marketing[209](index=209&type=chunk)[212](index=212&type=chunk) - The Inflation Reduction Act (IRA) directs HHS to negotiate prices for certain drugs, but drugs with an orphan drug designation as their only approved indication are excluded, which may benefit Annamycin if it maintains this status[254](index=254&type=chunk)[331](index=331&type=chunk) [Competition](index=40&type=section&id=1.6%20Competition) Moleculin operates in a highly competitive pharmaceutical market, facing competition from larger, better-resourced companies and established therapies for AML and STS lung metastases - The company faces intense competition from major pharmaceutical and biotechnology companies that possess significantly greater financial, manufacturing, and marketing resources[201](index=201&type=chunk) - In AML, key competitors include the standard "7+3" chemotherapy regimen, Jazz Pharmaceuticals' Vyxeos, AbbVie's Venclexta, and various targeted therapies for specific genetic mutations[203](index=203&type=chunk)[204](index=204&type=chunk)[205](index=205&type=chunk) - For STS lung metastases, the current standard of care includes anthracycline therapy and newer drugs like pazopanib, though few treatments specifically target lung metastases[206](index=206&type=chunk) [Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks inherent to a clinical-stage biotechnology firm, including uncertain clinical trial outcomes, reliance on single-source suppliers, significant regulatory hurdles, a history of financial losses, and intellectual property challenges - **Regulatory & Development Risks:** The company is developing drugs for terminally ill patients, and deaths in clinical trials could negatively impact the business, even if unrelated to the drug; there is no guarantee of obtaining regulatory approval, and delays in clinical trials are a significant risk[261](index=261&type=chunk)[272](index=272&type=chunk) - **Financial Risks:** The company has a history of significant losses, has never been profitable, and will require substantial additional funding to continue operations; failure to obtain funding could force the company to delay or cease operations, and its stock price is highly volatile[268](index=268&type=chunk)[359](index=359&type=chunk)[396](index=396&type=chunk) - **Intellectual Property Risks:** The composition of matter patent for the lead candidate, Annamycin, has expired, increasing reliance on formulation and method-of-use patents; the company's IP is licensed from MD Anderson and is subject to government rights due to federal funding[264](index=264&type=chunk)[335](index=335&type=chunk)[337](index=337&type=chunk) - **Operational Risks:** The company relies on a single source for the Active Pharmaceutical Ingredient (API) for certain drug candidates; it also faces risks from conducting clinical trials abroad, potential cybersecurity threats, and intense competition from better-funded companies[261](index=261&type=chunk)[274](index=274&type=chunk)[276](index=276&type=chunk) [Unresolved Staff Comments](index=92&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments - There are no unresolved staff comments[423](index=423&type=chunk) [Cybersecurity](index=93&type=section&id=Item%201C.%20Cybersecurity) The company has established policies for managing cybersecurity threats, integrated into its overall risk management, with board oversight and no material incidents reported to date - The company has integrated cybersecurity risk management into its overall risk management system, conducting annual assessments and engaging third-party consultants[424](index=424&type=chunk)[425](index=425&type=chunk) - Oversight is provided by the board of directors via the audit committee, with day-to-day management handled by the CFO and a consultant Head of IT and Cybersecurity[427](index=427&type=chunk)[428](index=428&type=chunk) - The company reports no known cybersecurity incidents that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[426](index=426&type=chunk) [Properties](index=94&type=section&id=Item%202.%20Properties) The company does not own any real property, leasing its corporate headquarters and laboratory facilities in Houston, Texas, under separate agreements - The company leases its corporate office and laboratory space in Houston, Texas, and does not own any real property[431](index=431&type=chunk)[432](index=432&type=chunk) - The corporate office lease extends to August 2029, and the lab lease extends to September 2027[431](index=431&type=chunk)[432](index=432&type=chunk) [Legal Proceedings](index=94&type=section&id=Item%203.%20Legal%20Proceedings) The company states that it is not currently involved in any legal proceedings that it believes could have a material effect on its business, financial condition, or operations - As of the filing date, the company is not involved in any legal proceedings expected to have a material impact[434](index=434&type=chunk) [Mine Safety Disclosure](index=94&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - Not applicable[435](index=435&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=95&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the NASDAQ Capital Market under "MBRX", with approximately 138 holders of record, and the company has never paid dividends nor anticipates doing so - Common stock is listed on the NASDAQ Capital Market under the symbol 'MBRX'[438](index=438&type=chunk) - The company has never paid dividends and does not intend to in the foreseeable future[440](index=440&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=96&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2023, the company reported a net loss of **$29.8 million**, slightly higher than 2022, with cash and equivalents decreasing to **$23.6 million**, raising substantial doubt about its going concern ability without additional financing Results of Operations (in thousands) | | Year ended December 31, 2023 | Year ended December 31, 2022 | | :--- | :--- | :--- | | Research and development | $19,487 | $18,968 | | General and administrative | $10,017 | $11,542 | | **Loss from operations** | **($29,631)** | **($30,640)** | | (Loss) gain from change in fair value of warrant liability | ($1,044) | $1,335 | | Interest income, net | $1,368 | $240 | | **Net loss** | **($29,769)** | **($29,025)** | - R&D expenses increased by **$0.5 million**, mainly due to a **$1.5 million** charge for the WPD sublicense termination, offset by timing of clinical trial costs; G&A expenses decreased by **$1.5 million** due to lower regulatory, legal, and consulting fees[457](index=457&type=chunk)[458](index=458&type=chunk) - As of December 31, 2023, the company had **$23.6 million** in cash and cash equivalents; management states this is sufficient to fund operations into **Q4 2024**, but notes these conditions raise substantial doubt about its ability to continue as a going concern[462](index=462&type=chunk)[463](index=463&type=chunk)[569](index=569&type=chunk) - In December 2023, the company raised gross proceeds of **$4.5 million** through a registered direct offering and private placement of common stock, pre-funded warrants, and common warrants[465](index=465&type=chunk) - The company is subject to an ongoing SEC investigation related to its drug candidate for COVID-19, incurring approximately **$1.5 million** in related legal fees in 2023, which has impacted liquidity[464](index=464&type=chunk)[570](index=570&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=105&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Moleculin is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide this information[502](index=502&type=chunk) [Financial Statements and Supplementary Data](index=105&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2023 and 2022, including the independent auditor's report with a "going concern" paragraph, balance sheets, statements of operations, cash flows, and stockholders' equity - The Report of Independent Registered Public Accounting Firm includes an explanatory paragraph expressing substantial doubt about the Company's ability to continue as a going concern due to its accumulated deficit and lack of revenue[541](index=541&type=chunk) Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $23,550 | $43,145 | | Total Assets | $38,217 | $57,422 | | Total Liabilities | $12,144 | $5,231 | | Total Stockholders' Equity | $26,073 | $52,191 | Consolidated Cash Flow Data (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($24,101) | ($27,639) | | Net cash used in investing activities | ($124) | ($67) | | Net cash provided by (used in) financing activities | $4,651 | ($23) | | **Net change in cash** | **($19,595)** | **($27,758)** | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=106&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports that there have been no disagreements with its independent registered public accountants on any accounting or financial disclosure matters during the two most recent fiscal years - No disagreements with accountants on accounting or financial disclosure matters were reported for the last two fiscal years[505](index=505&type=chunk) [Controls and Procedures](index=107&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2023, with no material changes identified - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[507](index=507&type=chunk) - Management's report on internal control over financial reporting concluded that such controls were effective as of December 31, 2023[508](index=508&type=chunk) [Other Information](index=107&type=section&id=Item%209B.%20Other%20Information) This section discloses a forum selection clause in the company's certificate of incorporation and confirms no Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers in Q4 2023 - The company's certificate of incorporation designates the Court of Chancery of the State of Delaware as the exclusive forum for certain stockholder litigation[510](index=510&type=chunk) - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement in the fourth quarter of 2023[512](index=512&type=chunk) Part III [Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, and Principal Accountant Fees](index=108&type=section&id=Items%2010%2C%2011%2C%2012%2C%2013%2C%20and%2014) Information for these items is incorporated by reference from the company's definitive proxy statement for its 2024 Annual Meeting of Stockholders, to be filed within 120 days of the fiscal year-end - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the company's forthcoming 2024 proxy statement[515](index=515&type=chunk)[517](index=517&type=chunk)[518](index=518&type=chunk)[519](index=519&type=chunk)[520](index=520&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=108&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides the index to the company's consolidated financial statements and a list of all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and certifications - This item provides the index to the financial statements and lists all exhibits filed with the report, including material agreements and certifications[522](index=522&type=chunk)[525](index=525&type=chunk) [Form 10-K Summary](index=113&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary - None[531](index=531&type=chunk)

Moleculin Biotech, Inc. (NASDAQ:MBRX) Q3 2023 Earnings Conference Call November 13, 2023 8:30 AM ET Company Participants Jenene Thomas - IR Walter Klemp - Chairman & CEO Paul Waymack - Senior CMO Jonathan Foster - EVP & CFO Conference Call Participants Jonathan Aschoff - ROTH MKM Jason McCarthy - Maxim Group Jeff Jones - Oppenheimer Operator Greetings, and welcome to the Moleculin Biotech Third Quarter 2023 Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded ...

Clinical Trials and Efficacy - Annamycin has shown no evidence of cardiotoxicity in 62 subjects treated across four clinical trials, with 50 of 66 subjects treated above the FDA's lifetime maximum anthracycline limit of 550 mg/m2[81]. - The Phase 1B portion of the clinical trial using Annamycin in combination with Cytarabine for AML has reported a total of 33% complete responses (CRs) among treated subjects[87]. - The combination trial for AML (MB-106) has shown a 68% improvement in activity with Annamycin combined with Cytarabine compared to Annamycin alone[78]. - The company has completed recruitment and treatment in one Phase 1B/2 trial and is actively monitoring progression-free survival and overall survival[76]. - The median age of subjects in the Phase 1B portion of the AML trial was 66 years, with a median of five prior therapies for the first cohort[85]. - Annamycin is being developed for the treatment of soft tissue sarcoma lung metastases and in combination with Cytarabine for acute myeloid leukemia[73]. - In the Phase 2 trial of Annamycin, 3 subjects were treated, with a complete response (CR) rate of 38% (n=8) across both phases[90]. - The median age of subjects in the Phase 2 trial is 69 years, with a median of 3 prior therapies[89]. - The median progression-free survival (PFS) for the MB-107 trial is 2.2 months, with a notable improvement to 3.4 months for subjects receiving lower doses of Annamycin (≤330 mg/m2)[101]. - The overall survival (OS) for subjects in the Phase 1B portion of the MB-107 trial is currently at 11 months[101]. - The company plans to complete recruitment for the Phase 2 trial by early 2024, potentially treating up to 21 subjects[89]. - A total of 32 subjects were treated in the MB-107 trial, with 27 receiving at least two cycles of treatment[96]. - The company presented preliminary efficacy findings from the MB-107 trial at the 2023 CTOS Annual Meeting in Dublin, Ireland[102]. Financial Performance - Research and development (R&D) expenses decreased to $3.3 million in Q3 2023 from $6.0 million in Q3 2022, a reduction of $2.7 million primarily due to timing of clinical trial costs[110]. - General and administrative expenses fell to $2.6 million in Q3 2023 from $3.1 million in Q3 2022, a decrease of $0.5 million attributed to lower regulatory and legal services[111]. - Net loss for Q3 2023 was $5.6 million compared to a net loss of $8.6 million in Q3 2022, reflecting an improvement in financial performance[109]. - Interest income increased by approximately $0.3 million in Q3 2023 due to rising interest rates, totaling $0.3 million compared to $0.03 million in Q3 2022[113]. - For the nine months ended September 30, 2023, R&D expenses were $12.9 million, down from $14.8 million in the same period of 2022, a decrease of $1.9 million[114]. - General and administrative expenses for the nine months ended September 30, 2023 were $7.8 million, down from $8.7 million in 2022, a decrease of $0.9 million[115]. - Net cash used in operating activities was $18.7 million for the nine months ended September 30, 2023, a decrease of $1.7 million from $20.4 million in the prior year[120]. - The company issued 225,568 shares of common stock at an average price of $0.94 per share, resulting in gross proceeds of $0.2 million during the nine months ended September 30, 2023[121]. - As of September 30, 2023, the company had $0.3 million in cash on hand in Australia, with no known limitations impacting liquidity[119]. - The company anticipates that existing cash and cash equivalents will fund planned operations into Q3 2024 without the need for additional equity issuance[122]. Future Plans and Developments - The company anticipates up to two externally funded Phase 1B/2 clinical trials for WP1066 in the treatment of GBM and other brain tumors in the first half of 2024[77]. - The company has established a Recommended Phase 2 Dose (RP2D) for WP1122 to enable future oncology and virology trials[74]. - The company has received approval for eleven clinical trials for four drug candidates, all in Phase 1 or 2 stages[75]. - The company expects to finalize agreements for externally funded trials for WP1066 in the second half of 2023[98]. - The company has submitted a final clinical study report for WP1122 in late October 2023, exploring further development avenues[100]. Licensing and Agreements - The termination of the WPD licensing agreement resulted in a payment of $700,000 in cash and $800,000 in common stock, along with acquiring rights to certain intellectual property[107].

PART I – FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Unaudited H1 2023 financial statements reveal a $13.9 million net loss, decreased assets, and a going concern risk due to limited cash [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to $47.1 million due to lower cash, while liabilities rose and equity declined Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $32,172 | $43,145 | | Total current assets | $35,380 | $45,596 | | Total assets | $47,115 | $57,422 | | **Liabilities and Stockholders' Equity** | | | | Accounts payable | $4,136 | $2,095 | | Total current liabilities | $6,554 | $4,819 | | Total liabilities | $6,847 | $5,231 | | Total stockholders' equity | $40,268 | $52,191 | | Total liabilities and stockholders' equity | $47,115 | $57,422 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $6.0 million for Q2 2023 and $13.9 million for H1 2023, with no revenue and increased R&D expenses Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Revenues | $— | $— | $— | $— | | Research and development | $3,888 | $4,204 | $9,576 | $8,824 | | General and administrative | $2,492 | $3,196 | $5,129 | $5,617 | | Loss from operations | $(6,411) | $(7,434) | $(14,766) | $(14,507) | | Net loss | $(5,976) | $(6,777) | $(13,891) | $(13,644) | | Net loss per common share | $(0.20) | $(0.24) | $(0.48) | $(0.48) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations for H1 2023 was $11.1 million, leading to an $11.0 million decrease in cash, ending at $32.2 million Condensed Consolidated Statements of Cash Flows (in thousands) | | Six Months Ended June 30, | | :--- | :--- | | | **2023** | **2022** | | Net cash used in operating activities | $(11,143) | $(12,806) | | Net cash used in investing activities | $(15) | $(67) | | Net cash provided by (used in) financing activities | $190 | $(12) | | Net decrease in cash and cash equivalents | $(10,973) | $(12,904) | | Cash and cash equivalents, - beginning of period | $43,145 | $70,903 | | Cash and cash equivalents, - end of period | $32,172 | $57,999 | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity decreased by $11.9 million to $40.3 million by June 30, 2023, primarily due to the $13.9 million net loss - Total stockholders' equity decreased by **$11.9 million** during the first six months of 2023, from **$52.2 million** to **$40.3 million**[18](index=18&type=chunk) - The decrease was primarily due to a net loss of **$7.9 million** in Q1 and **$6.0 million** in Q2, totaling **$13.9 million** for the six months[18](index=18&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage status, $115.7 million accumulated deficit, a going concern warning, NASDAQ delisting notice, and an SEC inquiry - The company is a Phase 2 clinical-stage pharmaceutical company with three core technologies licensed from MD Anderson Cancer Center[20](index=20&type=chunk) - A 'going concern' issue is raised, as the company's **$32.2 million** in cash as of June 30, 2023, is only sufficient to fund planned operations into the near term, not beyond[28](index=28&type=chunk) - The company has an accumulated deficit of **$115.7 million** and has not generated any revenue[28](index=28&type=chunk) - On May 5, 2023, the company received a NASDAQ delisting warning for its stock price closing below the **$1.00** minimum for 30 consecutive business days[21](index=21&type=chunk) - The company is responding to an SEC subpoena received in March 2022 regarding its drug candidate for COVID-19, incurring legal fees of **$0.9 million** in the first six months of 2023[29](index=29&type=chunk) - In March 2023, the company terminated its sublicense agreement with WPD Pharmaceuticals, paying **$700,000** in cash and **$800,000** in stock (**822,115 shares**) to reacquire intellectual property rights in certain territories[55](index=55&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical pipeline, Annamycin trial results, increased R&D expenses, and reiterates the going concern risk due to limited cash [Our Business and Focus](index=17&type=section&id=Our%20Business%20and%20Focus) The company is a clinical-stage pharmaceutical firm focused on hard-to-treat cancers and viruses, leveraging Annamycin and WP1066/WP1122 portfolios - The company's three core technologies are Annamycin, the WP1066 Portfolio, and the WP1122 Portfolio[63](index=63&type=chunk)[65](index=65&type=chunk) - Current internally funded development is focused on: - Annamycin for Soft Tissue Sarcoma (STS) lung metastases - Annamycin in combination with Cytarabine (AnnAraC) for Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) - A new formulation for WP1066[68](index=68&type=chunk)[69](index=69&type=chunk) - The company is actively recruiting for three clinical trials in Phase 1b or Phase 2 and supports several externally funded trials[72](index=72&type=chunk) [Recent Business Developments](index=21&type=section&id=Recent%20Business%20Developments) Recent developments include positive clinical trial updates for Annamycin in AML and STS lung mets, and the termination of the WPD sublicense agreement - **MB-106 (Annamycin for AML):** The Phase 1b portion of the combination trial with Cytarabine resulted in a **33% CR/CRi rate** (**2 of 6 subjects**)[78](index=78&type=chunk)[82](index=82&type=chunk) - **MB-107 (Annamycin for STS lung mets):** In the Phase 2 trial, **67%** of the 15 subjects treated at the **330 mg/m² dose** have exhibited stable disease after two cycles[86](index=86&type=chunk) - Across all dose levels, **73%** of 26 evaluable subjects showed stable disease[86](index=86&type=chunk) - **WP1066:** The company expects to finalize agreements with Northwestern University for an externally funded trial for glioblastomas in the second half of 2023 and is working on an IV formulation[88](index=88&type=chunk)[89](index=89&type=chunk) - **WPD License Termination:** In March 2023, the company terminated its agreement with WPD, reacquiring rights to Annamycin, WP1122, and WP1066 portfolios in certain territories[95](index=95&type=chunk) - The company also gained rights to a grant-supported trial in Poland valued at approximately **$1.5 million**[95](index=95&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) For H1 2023, R&D expenses increased by $0.8 million to $9.6 million, while G&A expenses decreased by $0.5 million, with no revenue generated Comparison of Operating Expenses (in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | Research and development | $3,888 | $4,204 | $9,576 | $8,824 | | General and administrative | $2,492 | $3,196 | $5,129 | $5,617 | - **Six-Month Change:** R&D expense increased by **$0.8 million**, mainly due to the WPD sublicense termination[102](index=102&type=chunk) - G&A expense decreased by **$0.5 million** due to lower regulatory, legal, and consulting fees[103](index=103&type=chunk) - **Three-Month Change:** R&D expense decreased by **$0.3 million** due to the timing of clinical trial costs[98](index=98&type=chunk) - G&A expense decreased by **$0.7 million**, also from lower legal and consulting fees[99](index=99&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, cash was $32.2 million, with $11.1 million used in operations, raising substantial doubt about the company's going concern status without further financing Sources and Uses of Cash (in thousands) | | Six Months Ended June 30, | | :--- | :--- | | | **2023** | **2022** | | Net cash used in operating activities | $(11,143) | $(12,806) | | Net decrease in cash and cash equivalents | $(10,973) | $(12,904) | - Cash and cash equivalents were **$32.2 million** as of June 30, 2023[109](index=109&type=chunk) - Management believes existing cash is sufficient to fund planned operations into the third quarter of 2024[109](index=109&type=chunk) - However, this condition raises substantial doubt about the company's ability to continue as a going concern[109](index=109&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - Not applicable as the company is a smaller reporting company[112](index=112&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes in internal control over financial reporting - The CEO and CFO have determined that disclosure controls and procedures were effective as of June 30, 2023[113](index=113&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[114](index=114&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings - None[116](index=116&type=chunk) [Risk Factors](index=27&type=page&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022 - No material changes from the risk factors previously disclosed in the annual report on Form 10-K for the year ended December 31, 2022[117](index=117&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20sales%20of%20Equity%20Securities%20and%20Uses%20of%20Proceeds) During H1 2023, the company issued warrants to purchase 150,000 common shares at $0.60 per share to two consulting entities - Issued warrants to purchase **150,000 shares** of common stock at an exercise price of **$0.60 per share** to two consulting entities[118](index=118&type=chunk) [Defaults Upon Senior Securities](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[119](index=119&type=chunk) [Mine Safety Disclosures](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[120](index=120&type=chunk) [Other Information](index=27&type=section&id=Item%205.%20Other%20Information) During the reporting period, none of the company's directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - No director or executive officer has adopted or terminated a Rule 10b5-1 trading arrangement during the period[121](index=121&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the 2015 Stock Plan, CEO and CFO certifications pursuant to the Sarbanes-Oxley Act, and Inline XBRL data files - Exhibits filed include the 2015 Stock Plan, CEO/CFO certifications (302 and 906), and XBRL files[122](index=122&type=chunk)

Moleculin Biotech, Inc. (NASDAQ:MBRX) Q1 2023 Earnings Conference Call May 11, 2023 8:30 AM ET Company Participants Jenene Thomas - Investor Relations Walter Klemp - Chairman and Chief Executive Officer John Paul Waymack - Senior Chief Medical Officer Jonathan Foster - Executive Vice President and Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH MKM Jeff Jones - Oppenheimer Operator Hello and welcome to the Moleculin Biotech Q1 2023 Quarterly Update Conference Call and Webcast. [ ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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: 001-37758 MOLECULIN BIOTECH, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Inc ...

Moleculin Biotech, Inc. (NASDAQ:MBRX) Q4 2022 Earnings Conference Call March 23, 2023 8:30 AM ET Company Participants Jenene Thomas - Investor Relations Walter Klemp - Chairman and Chief Executive Officer John Paul Waymack - Senior Chief Medical Officer Jonathan Foster - Executive Vice President and Chief Financial Officer Conference Call Participants Jonathan Aschoff - ROTH MKM Jeff Jones - Oppenheimer Operator Hello and welcome to the Moleculin Biotech Fiscal Year 2022 Quarterly Update Conference Call and ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF For the transition period from to Commission File Number: 001-37758 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of (Primary Stan ...

Moleculin Biotech, Inc. (NASDAQ:MBRX) Q3 2022 Earnings Conference Call November 10, 2022 5:00 PM ET Company Participants Walter Klemp – Chairman and Chief Executive Officer Jonathan Foster – Executive Vice President and Chief Financial Officer Conference Call Participants Jonathan Aschoff – ROTH Capital Operator Hello, and welcome to the Moleculin Biotech Inaugural Quarterly Update Conference Call and Webcast. As a brief reminder, all participants are currently in a listen-only mode. [Operator Instructions] ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 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: 001-37758 MOLECULIN BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 2834 47-4671997 (State ...