October 2022 CORPORATE PRESENTATION (NASDAQ:FWBI) Targeted, Non-Systemic Therapeutics for Gastrointestinal Diseases www.firstwavebio.com | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ...

Financial Position - First Wave BioPharma reported a stockholders' deficit of $(6,969,988) as of September 30, 2021, indicating non-compliance with Nasdaq's $2.5 million minimum stockholders' equity requirement[188]. - As of June 30, 2022, the company had cash and cash equivalents of approximately $1.2 million and cumulative losses attributable to common stockholders of approximately $168.9 million[204]. - The company anticipates needing to generate significant product revenues to achieve profitability and may never achieve profitability[204]. - The company recorded a net decrease in cash and cash equivalents of approximately $7.1 million for the six months ended June 30, 2022[233]. Clinical Trials and Development - The company initiated a Phase 2b monotherapy trial for adrulipase in the second half of 2022, focusing on treating exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients[177]. - The Phase 2 RESERVOIR COVID-19 GI clinical trial for niclosamide did not meet its efficacy endpoint, but demonstrated safety with no serious adverse events reported among over 150 participants[179]. - The company is evaluating further development of niclosamide therapies for additional inflammatory bowel disease indications, including ulcerative colitis and Crohn's disease[181]. - The FDA granted clearance for an investigational new drug application for a Phase 2 trial targeting immune checkpoint inhibitor-associated colitis, which is currently on hold due to financial constraints[181]. Financial Performance - For the three months ended June 30, 2022, total operating expenses were approximately $5.4 million, a decrease of approximately $3.9 million, or 42%, compared to approximately $9.3 million for the same period in 2021[221]. - Research and development expenses for the three months ended June 30, 2022, totaled approximately $2.9 million, a decrease of approximately $2.7 million, or 49%, compared to approximately $5.6 million for the same period in 2021[213]. - General and administrative expenses for the three months ended June 30, 2022, totaled approximately $2.5 million, a decrease of approximately $1.1 million, or 31%, compared to approximately $3.6 million for the same period in 2021[218]. - The net loss for the three months ended June 30, 2022, was approximately $5.4 million, a decrease of approximately $3.9 million, or 42%, compared to approximately $9.3 million for the same period in 2021[221]. - For the six months ended June 30, 2022, total operating expenses were approximately $14.8 million, a decrease of approximately $2.7 million, or 15%, compared to approximately $17.5 million for the same period in 2021[222]. - Research and development expenses for the six months ended June 30, 2022, totaled approximately $7.9 million, a decrease of approximately $0.3 million, or 3%, compared to approximately $8.2 million for the same period in 2021[223]. - General and administrative expenses for the six months ended June 30, 2022, totaled approximately $6.9 million, a decrease of approximately $2.4 million, or 26%, compared to approximately $9.3 million for the same period in 2021[228]. - The net loss for the six months ended June 30, 2022, was approximately $15.0 million, a decrease of 11% from the net loss of approximately $16.9 million for the same period in 2021[232]. Cost Management - The company has implemented cost-reduction measures, including headcount reduction and closure of facilities, to conserve capital amid ongoing volatility in the biotechnology sector[182]. - General and administrative expenses decreased by approximately $1.9 million, primarily due to reductions in public company costs, stock-based compensation, and advisory fees[229]. - The company expects general and administrative expenses to decrease for the remainder of the fiscal year due to capital conservation efforts[230]. Financing Activities - The company reached a settlement agreement on July 29, 2022, agreeing to pay $1.5 million in cash immediately, with additional payments totaling $3.0 million due by November 30, 2022, contingent on certain milestones[183]. - The company has entered into Temporary Waivers with holders of approximately $2.88 million of stated value of Series B Preferred Stock to waive certain rights related to subsequent financing[195]. - The Permanent Waiver was executed by holders of 81.3% of the outstanding shares of Series B Preferred Stock, waiving their exchange rights for any subsequent financing occurring on or after January 1, 2022[197]. - Net cash provided by financing activities for the six months ended June 30, 2022, was approximately $5.4 million, mainly from the net proceeds of approximately $8.0 million from a registered direct offering[237]. Other Financial Information - Other expenses for the six months ended June 30, 2022, totaled approximately $0.2 million, an increase of 147% compared to other income of approximately $(0.5) million for the same period in 2021[231]. - Cash flows from investing activities for the six months ended June 30, 2021, included approximately $9.0 million related to the FWB License Agreement[236]. - The net cash used in investing activities for the six months ended June 30, 2021, was approximately $9.1 million, primarily for the FWB License Agreement[236]. - There were no material changes in internal control over financial reporting during the period covered by the report[243].

Financial Position - As of March 31, 2022, the company had cash and cash equivalents of approximately $5.7 million and cumulative losses attributable to common stockholders of approximately $163.5 million[168]. - The company anticipates having sufficient cash to fund planned operations into June 2022, but may need to raise additional capital depending on cash outflows[168]. - The company entered into waivers with holders of approximately $2.88 million of stated value of its Series B Preferred Stock to manage its financial obligations[164]. - The company is subject to potential delisting from Nasdaq due to non-compliance with minimum stockholders' equity requirements[161]. Operational Changes - The company has initiated a 20% reduction in headcount and closed its California office to conserve capital due to financial constraints[160]. - The company is implementing capital conservation measures, including headcount reductions, to manage expenses[179]. - The company is seeking to renegotiate obligations to former FWB stockholders to conserve capital, with no assurance of successful restructuring[175]. Clinical Development - The company received FDA clearance for an IND application for a Phase 2 trial for Immune Checkpoint Inhibitor-associated colitis, but the program is currently on hold[160]. - The company is focused on developing adrulipase and niclosamide, with ongoing Phase 2 clinical trials for both drug candidates[156][170]. - The company has been impacted by the COVID-19 pandemic, which has caused delays in clinical trial patient enrollment[165]. Financial Performance - For the three months ended March 31, 2022, total operating expenses were approximately $9.4 million, an increase of $1.2 million, or 14% compared to $8.2 million for the same period in 2021[176]. - Research and development expenses for the three months ended March 31, 2022 totaled approximately $5.0 million, an increase of approximately $2.5 million, or 98% over the approximately $2.5 million recorded for the same period in 2021[177]. - The increase in research and development expenses was primarily due to a $2.2 million rise in clinical-related expenses for the Phase 2 RESERVOIR COVID-19 GI clinical trial compared to two Phase 2 clinical trials related to adrulipase in the prior year[178]. - General and administrative expenses for the three months ended March 31, 2022 totaled approximately $4.4 million, a decrease of approximately $1.3 million, or 23% from $5.7 million in the same period in 2021[181]. - The net loss for the three months ended March 31, 2022 was approximately $9.6 million, an increase of approximately $1.9 million, or 25% compared to the net loss of approximately $7.7 million for the same period in 2021[185]. - Net cash used in operating activities for the three months ended March 31, 2022 was approximately $7.9 million, compared to $5.1 million for the same period in 2021[186]. - Net cash provided by financing activities for the three months ended March 31, 2022 was approximately $5.4 million, primarily due to net proceeds of approximately $8.0 million from a registered direct offering[189]. - The company expects research and development expenses to decrease as it nears completion of two clinical trials for niclosamide[179]. Going Concern - The company has not generated any revenues to date and continues to incur net losses, raising substantial doubt about its ability to continue as a going concern[167][170]. - The company is evaluating potential asset acquisitions and partnerships to expand its product pipeline[171].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 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 001-37853 FIRST WAVE BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 46-4993860 (State or other jur ...

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 UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-37853 FIRST WAVE BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 46-4993860 (State or other jurisdiction of ...

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 UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-37853 AZURRX BIOPHARMA, INC. (Exact name of small business issuer as specified in its charter) (State or other jurisdiction of incorporation or o ...

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 UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-37853 AZURRX BIOPHARMA, INC. (Exact name of small business issuer as specified in its charter) Delaware 46-4993860 (State or other jurisdict ...

| --- | --- | |-------|------------------------| | | | | | | | | CORPORATE PRESENTATION | | | | C O N F I D E N T I A L | www.azurrx.com Company Disclaimer Certain statements in this presentation constitute "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Any statements that refer to expectations or other characterizations of future events, circumstances or results are forward-looking statements. Such forwardlooking statements include project ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K [X]ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 or [ ]TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file No. 001-37853 AZURRX BIOPHARMA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. employer identification number) ...

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 UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934 From the transition period from to Commission File Number 001-37853 AZURRX BIOPHARMA, INC. (Exact name of small business issuer as specified in its charter) (State or other jurisdiction of incorpora ...