Experimental Therapeutics Centre

Enrollment Ongoing in Phase 3 Part of 2/3 Pivotal Trial of Epetraborole in Treatment-Refractory Mycobacterium avium complex (MAC) Lung Disease MENLO PARK, Calif.--(BUSINESS WIRE)-- AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced two oral presentations and three poster presentations at the Infectious Disease Society of America (IDSA) IDWeek 2023 Conference from October 11-15, 2023 in Boston, Massachusetts. AN2 Therapeutics is currently enrolling patients in the Phase 3 part of its pivotal Phase 2/3 clinical trial evaluating once-daily, oral epetraborole for treatment-refractory Mycobacterium avium complex (MAC) lung disease. “We are excited to showcase our latest data at IDWeek 2023. These results highlight epetraborole’s potent nonclinical activity against MAC isolates, as well as M. abscessus, another difficult-to-treat NTM pathogen. Additionally, epetraborole demonstrated favorable pharmacokinetics at the current dose in patients with various degrees of renal impairment and in Japanese subjects with different alcohol dehydrogenase genotypes, which further supports our dosing strategy in patients with treatment-refractory MAC lung disease,” said Paul Eckburg, M.D., Chief Medical Officer of AN2 Therapeutics. “These data, combined with results from our ongoing pivotal Phase 2/3 study — which is currently enrolling participants in the Phase 3 portion — are expected to provide the basis for regulatory filings for approval in the U.S. and Japan. We are enthusiastic about the progress we have achieved so far and look forward to advancing our mission to develop a novel therapy for patients with treatment-refractory MAC lung disease." Oral presentations pertaining to epetraborole: Title: Epetraborole: A Novel Antibiotic for NTM Lung Disease & Melioidosis Session: New Antimicrobials in the Pipeline Part 1 Date: Thursday, October 12, 2023 Time: 8:48 AM – 9:00 AM ET Room: 104ABC Presentation # 32 Title: In Vitro Susceptibility of Recent Mycobacterium abscessus Isolates to Epetraborole (EBO) and Comparators by Broth Microdilution Session: Experimental Therapeutics Date: Saturday, October 14, 2023 Time: 10:54 AM – 11:06 AM ET Location: 102AB Presentation # 2064 Poster presentations pertaining to epetraborole: Title: A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics (PK) of Oral Epetraborole Tablets in Adult Subjects with Varying Degrees of Renal Function Session: Antimicrobial Novel Agents Date: Saturday, October 14, 2023 Time: 12:15 PM - 1:30 PM ET Location: Hall B&C Presentation # 2144 Title: A Phase 1, Open-Label, Single Dose Study to Evaluate the Pharmacokinetics (PK), Safety, and Tolerability of Epetraborole Tablets and the Impact of Alcohol Dehydrogenase (ADH) Genotype on the PK of Epetraborole and Metabolite M3 in Healthy Japanese Adult Subjects Session: PK/PD Studies Date: Saturday, October 14, 2023 Time: 12:15 PM - 1:30 PM ET Location: Hall B&C Presentation # 2556 Title: Epetraborole in vitro Activity Against Mycobacterium avium complex Recent Clinical Isolates from Japan Session: Antimicrobial Novel Agents Date: Saturday, October 14, 2023 Time: 12:15 PM - 1:30 PM ET Location: Hall B&C Presentation # 2135 About AN2 Therapeutics, Inc. AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. Our initial candidate is epetraborole, which we are studying as a once-daily, oral treatment with a novel mechanism of action for patients with nontuberculous mycobacteria (NTM) lung disease, a rare, chronic, and progressive infectious disease caused by bacteria known as mycobacteria, that leads to irreversible lung damage and can be fatal. For more information, please visit our website at . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the timing, progress, and anticipated results from AN2's Phase 2/3 pivotal clinical trial; AN2's anticipated progress, business plans, business strategy and planned clinical trials; the potential clinical benefits and therapeutic potential of epetraborole; and other statements that are not historical fact. These statements are based on AN2's current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the continuing effects of the COVID-19 pandemic; macroeconomic conditions; AN2's ability to progress enrollment in its Phase 2/3 pivotal clinical trial of epetraborole; the ability of AN2 to effectively and timely make amendments to the Phase 2/3 pivotal trial design pursuant to additional FDA feedback; timely enrollment of patients in its current and future clinical trials; AN2's ability to procure sufficient supply of its product candidate for its existing and future clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with AN2's product candidate; the significant uncertainty associated with AN2's product candidate ever receiving any regulatory approvals; AN2's ability to obtain, maintain or protect intellectual property rights related to its current and future product candidates; implementation of AN2's strategic plans for its business and current and future product candidates; the sufficiency of AN2's capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading “Risk Factors” in AN2's reports to be filed with the SEC, including AN2’s Report on Form 10-Q for the quarter ended June 30, 2023. These filings, when available, are available on the investor relations section of our website at investor.an2therapeutics.com and on the SEC's website at . Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law. View source version on businesswire.com: Contacts COMPANY CONTACT: Lucy O. Day Chief Financial Officer l.day@an2therapeutics.com INVESTOR AND MEDIA CONTACT: Anne Bowdidge ir@an2therapeutics.com Source: AN2 Therapeutics, Inc. View this news release online at:

SAN DIEGO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced new data on its drug-Fc conjugate (DFC) candidate, CD388, at IDWeek 2023. The conference is taking place both in-person at the Boston Convention and Exhibition Center in Boston, MA and virtually from October 11 – 15, 2023. “It is important to highlight these new data demonstrating the safety, efficacy and tolerability of CD388 in preventing influenza A and B,” said Jeffrey Stein, Ph.D. president and chief executive officer of Cidara. “These data support the conclusions drawn from the Phase 2a study, additional data from which will be disclosed at an upcoming conference, that CD388 has the potential to offer true universal protection for patients regardless of their immune status. These data continue to support the unique approach of our Cloudbreak platform which aims to design DFCs that may safely and effectively prevent and treat serious diseases such as influenza and cancer.” CD388 is being developed for the universal protection of influenza A and B under an exclusive worldwide collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company. Janssen recently delivered its Election to Proceed Notice for CD388 with the intent to transfer its rights and obligations to another entity. Presentation details are summarized below: Title: In Vivo Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), Against Seasonal Subtypes of Influenza in Prophylaxis in Immune Competent Mice, and in a Severe Immunodeficient (SCID) Mouse Model Presenter: James Levin, Ph.D., Cidara Therapeutics Session Title: Experimental Therapeutics Session Location: 102 AB Date and Time: October 14, 2023, 10:30AM – 11:45 AM ET Title: Single Ascending Dose Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza Presenter: Shawn Flanagan, Ph.D., Cidara Therapeutics Session Title: New Antimicrobial Drug Development Session Location: Hall B&C Date and Time: October 14, 2023, 12:15– 1:30 PM ET Title: Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), is Driven by the Small Molecule Neuraminidase Inhibitor (NAI) Presenter: James Levin, Ph.D., Cidara Therapeutics Session Title: Antimicrobial Novel Agents Session Location: Hall B&C Date and Time: October 14, 2023, 12:15PM – 1:30PM ET About Cidara Therapeutics Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether Janssen or an assignee will conduct additional clinical trials of CD388, and whether CD388 will ultimately be proven safe or effective for prevention of influenza infection or any indication. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT: Brian Ritchie LifeSci Advisors (212) 915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Veronica Eames LifeSci Communications (646) 970-4682 veames@lifescicomms.com

SAN DIEGO, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that it will present new data on its drug-Fc conjugate (DFC) candidate, CD388, in an oral presentation and two poster presentations at IDWeek 2023. The conference will take place both in-person at the Boston Convention and Exhibition Center in Boston, MA and virtually from October 11 – 15, 2023. CD388 is being developed for the universal protection of influenza A and B under an exclusive worldwide collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company. Janssen recently delivered its Election to Proceed Notice for CD388 with the intent to transfer its rights and obligations to another entity. Presentation details are summarized below: Title: In Vivo Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), Against Seasonal Subtypes of Influenza in Prophylaxis in Immune Competent Mice, and in a Severe Immunodeficient (SCID) Mouse Model Presenter: James Levin, Ph.D., Cidara Therapeutics Session Title: Experimental Therapeutics Session Location: 102 AB Date and Time: October 14, 2023, 10:30AM – 11:45 AM ET Title: Single Ascending Dose Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza Presenter: Shawn Flanagan, Ph.D., Cidara Therapeutics Session Title: New Antimicrobial Drug Development Session Location: Hall B&C Date and Time: October 14, 2023, 12:15– 1:30 PM ET Title: Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), is Driven by the Small Molecule Neuraminidase Inhibitor (NAI) Presenter: James Levin, Ph.D., Cidara Therapeutics Session Title: Antimicrobial Novel Agents Session Location: Hall B&C Date and Time: October 14, 2023, 12:15PM – 1:30PM ET IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). About Cidara Therapeutics Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA approval for REZZAYO™ (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “believe,” “could,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether Janssen will identify another party and consummate an assignment transferring the rights and obligations related to CD388, whether Janssen or an assignee will conduct additional clinical trials of CD388, and whether CD388 will ultimately be proven safe or effective for prevention of influenza infection or any indication. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of CD388 development. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT: Brian Ritchie LifeSci Advisors (212) 915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Veronica Eames LifeSci Communications (646) 970-4682 veames@lifescicomms.com