On November 12, 2025 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and announced financial results for the fiscal quarter ended September 30, 2025.

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"Our RAS-targeting franchise continues to advance rapidly, with multiple important clinical milestones approaching," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "A U.S. patent was issued that covers the composition of matter for our potential best-in-class pan-RAS molecular glue ERAS-0015, the first of several patents we anticipate may be issued, which would strengthen the intellectual property surrounding our differentiated RAS portfolio. We also reinforced our scientific leadership with the promotion of Robert Shoemaker, Ph.D., to chief scientific officer. As a core member of Erasca’s founding team, Robert has been instrumental in shaping our research strategy since company inception."

Dr. Lim continued, "Clinical development of ERAS-0015 and our potential best-in-class pan-KRAS inhibitor ERAS-4001 is on track, with initial Phase 1 monotherapy data for both ERAS-0015 and ERAS-4001 expected in 2026. With a strong balance sheet and a cash runway into the second half of 2028, we are well-positioned to drive our programs forward and deliver new therapeutic options with the potential to address high unmet needs of patients with RAS-driven cancers."

Research and Development (R&D) Highlights

U.S. Composition of Matter Patent Issued for ERAS-0015: In November 2025, Erasca announced that the U.S. Patent and Trademark Office issued patent No. 12,458,647 covering the composition of matter for potentially best-in-class pan-RAS molecular glue ERAS-0015 and related compositions until September 2043, absent any patent term adjustments or extensions.

Corporate Highlights

Strengthened Scientific Leadership: In November 2025, Erasca promoted Robert Shoemaker, Ph.D., previously Erasca’s senior vice president of research, to chief scientific officer.

Key Upcoming Milestones

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AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RAS-mutant solid tumors
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Initial Phase 1 monotherapy data expected in 2026
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BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRAS-mutant solid tumors
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Initial Phase 1 monotherapy data expected in 2026

Third Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $362.4 million as of September 30, 2025, compared to $440.5 million as of December 31, 2024. Erasca expects its cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2028.

Research and Development (R&D) Expenses: R&D expenses were $22.5 million for the quarter ended September 30, 2025, compared to $27.6 million for the quarter ended September 30, 2024. The decrease was primarily driven by decreases in expenses incurred in connection with clinical trials, preclinical studies, discovery activities, outsourced services, and consulting fees.

General and Administrative (G&A) Expenses: G&A expenses were $10.1 million for the quarter ended September 30, 2025, compared to $9.6 million for the quarter ended September 30, 2024. The increase was primarily driven by increases in legal fees and personnel costs, including stock-based compensation expense.

Net Loss: Net loss was $30.6 million, or $(0.11) per basic and diluted share, for the quarter ended September 30, 2025, compared to $31.2 million, or $(0.11) per basic and diluted share, for the quarter ended September 30, 2024.

(Press release, Erasca, NOV 12, 2025, View Source [SID1234659818])

On November 12, 2025 XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its 2025 third quarter and year to date financial results and highlighted recent actions that have the potential to deliver additional shareholder value.

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"We continue to execute on innovative ways to increase optionality within our portfolio while maintaining a healthy cash balance and limiting dilution to our shareholders," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "Growing royalty receipts reflect solid commercial execution on the part of our partners. We look forward to several clinical readouts over the coming months and quarters that, if positive, can meaningfully shape our business trajectory."

Royalty and Milestone Acquisitions

Company

Asset and Transaction Detail

LAVA Therapeutics

XOMA Royalty will secure an economic interest in PF-08046052, which is being developed by Pfizer, and JNJ-89853413, which is being developed by Johnson & Johnson, upon closing its acquisition of LAVA.
Company Acquisitions

Company

Transaction Details

Turnstone Biologics

XOMA Royalty acquired Turnstone for $0.34 in cash per share of Turnstone common stock plus one non-transferable contingent value right (CVR).
HilleVax

XOMA Royalty acquired HilleVax for a cash payment of $1.95 per share plus a non-transferable CVR that entitles holders to receive certain potential payments.
LAVA Therapeutics

XOMA Royalty will acquire LAVA for (i) an initial cash amount per share of $1.04 plus (ii) a non-transferable CVR per share representing the right to receive certain cash payments, including (A) the previously announced rights to receive, among other things, 75% of the net proceeds related to LAVA’s two partnered assets plus 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs, plus (B) a new right to receive up to approximately $0.23 per CVR depending on the final determination after closing of certain potential liabilities.
Mural Oncology

XOMA Royalty will acquire Mural Oncology through its wholly owned subsidiary XRA 5 Corp. for between $2.035 and $2.24 in cash per share. The acquisition is expected to close in the fourth quarter of 2025.1,2
XenoTherapeutics Acquisition of ESSA Pharma

XOMA Royalty acted as structuring agent for XenoTherapeutics’ completed acquisition of ESSA Pharma.
Pipeline Partner Updates through November 10, 2025

Partner

Event

Rezolute

In September, Rezolute announced it had achieved alignment with FDA on a significantly streamlined clinical development path for its ongoing Phase 3 study (upLIFT) of ersodetug for the treatment of tumor HI. Topline results are expected in the second half of 2026.3
Takeda

The first patient was dosed in Takeda’s Phase 3 clinical trial investigating mezagitamab as a treatment for adults with IgA Nephropathy.

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Zevra Therapeutics

On July 28, Zevra announced it had submitted an MAA to EMA for the evaluation of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC)4.
Gossamer Bio

Activated first clinical site for the global, registrational Phase 3 SERANATA study examining seralutinib in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the fourth quarter of 20255.
Daré Biosciences

Announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety, and acceptability of Ovaprene, an investigational monthly, hormone-free intravaginal contraceptive.6
Anticipated Partner Events of Note through Mid-2026

Partner

Event

Rezolute

Announces topline data in December 20257 from sunRIZE Phase 3 clinical trial, which is investigating ersodetug in infants and children with congenital HI.
Gossamer Bio

Publishes topline results from the Phase 3 PROSERA Study evaluating seralutinib in Functional Class II and III PAH patients5.
Daré Bioscience

Makes DARE to PLAY Sildenafil Cream available commercially via prescription in the fourth quarter of 2025 as a compounded drug under Section 503B of the Federal Food, Drug, and Cosmetic Act.8

Commences one of two registrational Phase 3 clinical trials investigating Sildenafil Cream, 3.6%, for the treatment of female sexual arousal disorder9. Discussions with FDA regarding endpoint assessment for Phase 3 clinical studies of Sildenafil Cream, 3.6% continue8.

Day One Biopharmaceuticals

Per the Day One conference call held on November 4, 2025, Ipsen, Day One’s partner outside the U.S., expects to receive EMA regulatory decision on its application to commercialize tovorafenib in the European Union.

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Third Quarter and Year to Date 2025 Financial Results

Tom Burns, Chief Financial Officer of XOMA Royalty, commented, "In the first nine months of 2025, we have received $43.9 million in cash from partners, of which $30.3 million were royalty payments related to commercial sales and $13.6 million in milestone payments and fees. In the third quarter, we received $14.3 million in cash from our partners’ commercial sales. With well-executed commercialization efforts by our partners and the emergence of new commercial opportunities from within our portfolio, XOMA Royalty has the potential to become a self-sustaining entity from royalties alone over the near term."

Income and Revenue: Income and revenue for the three and nine months ended September 30, 2025, were $9.4 million and $38.4 million, respectively, as compared with $7.2 million and $19.8 million for the corresponding periods of 2024. The increase in both periods presented was primarily driven by increased income related to VABYSMO and OJEMDA.

Research and Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2025, were $69 thousand and $1.4 million, respectively, compared with $0.8 million and $2.0 million for each of the corresponding periods of 2024. R&D expenses in the first quarter of 2025 and the three- and nine-month periods of 2024 were related to the clinical trial costs incurred subsequent to XOMA Royalty’s acquisition of Kinnate in April 2024 related to KIN-3248 and the associated wind-down activities.

General and Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2025, were $9.7 million and $25.7 million, respectively, as compared with $8.0 million and $27.5 million for the corresponding periods of 2024. The increase of $1.7 million for the three months ended September 30, 2025, as compared to the same period in 2024, was primarily due to an increase in business development and deal-related costs, partially offset by a decrease in stock-based compensation expense. For the nine months ended September 30, 2025, the decrease of $1.8 million, as compared to the same period in 2024, was primarily due to costs related to exit packages for Kinnate senior leadership in the second quarter of 2024 and a decrease in stock-based compensation expense, partially offset by an increase in business development and deal-related costs.

XOMA Royalty’s G&A expenses included non-cash stock-based compensation expenses during the three and nine months ended September 30, 2025, of $1.8 million and $5.4 million, respectively, as compared to $2.6 million and $8.1 million for the corresponding periods of 2024. The 2024 periods reflect non-cash stock-based compensation related to the appointment of Mr. Hughes to full-time Chief Executive Officer and issuance of performance stock units.

Credit Losses on Purchased Receivables: During the nine months ended September 30, 2024, XOMA Royalty recorded one-time, non-cash credit losses on purchased receivables associated with the Aronora and Agenus assets. To date, there have been no credit losses in 2025.

Amortization of Intangible Assets: Amortization of intangible assets relates to the IP acquired in the Company’s acquisitions of Pulmokine in November 2024 and the mezagitamab economics from the BioInvent transaction in May 2025. Amortization of non-cash intangible assets were $0.9 million and $2.1 million for the three and nine months ended September 30, 2025.

Gains on Acquisitions: In the third quarter of 2025, XOMA Royalty recorded gains on acquisitions of $17.9 million for HilleVax and $1.8 million for Turnstone.

Interest Expense: For the three and nine months ended September 30, 2025, interest expense was $3.3 million and $10.0 million, respectively, as compared with $3.5 million and $10.4 million for the corresponding periods of 2024. Interest expense relates to the Blue Owl Loan established in December 2023.

Other Income, net: For the three and nine months ended September 30, 2025, other income, net was $0.7 million and $8.5 million, respectively, as compared with $1.9 million and $5.9 million for the corresponding periods of 2024.

Net Income: XOMA Royalty reported net income of $14.1 million and $25.6 million for the three and nine months ended September 30, 2025, as compared to net losses of $17.2 million and $9.9 million in the corresponding periods of 2024.

Cash Position: On September 30, 2025, XOMA Royalty had cash and cash equivalents of $130.6 million, including $85.4 million in restricted cash. The restricted cash balance included $43.3 million related to the assumed HilleVax lease, $39.9 million reserved to fund the Mural acquisition, and $2.2 million related to the Blue Owl Loan. Cash and cash equivalents of $106.4 million as of December 31, 2024, included $4.8 million in restricted cash related to the Blue Owl Loan.

In the third quarter of 2025, XOMA Royalty received $14.3 million in cash receipts from royalties and commercial payments and paid $1.4 million in dividends on the XOMA Royalty Perpetual Preferred stocks. In the first nine months of 2025, XOMA Royalty received $43.9 million in cash receipts, including $30.3 million in royalties and commercial payments and $13.6 million in milestone payments and fees. During the first nine months of 2025, XOMA Royalty deployed $25.0 million to acquire additional assets for its royalty and milestone portfolio, repurchased approximately 108,510 shares of its common stock for a cost of $2.4 million, and paid $4.1 million in dividends on the XOMA Royalty Perpetual Preferred stocks.

(Press release, Xoma, NOV 12, 2025, View Source [SID1234659833])

On November 12, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported that data from multiple pipeline programs, including long-term and safety results from its MOTION Phase 3 study of vimseltinib in patients with TGCT in cases where surgical removal of the tumor is not an option, will be presented during the CTOS Annual Meeting 2025, taking place November 12-15 in Boca Raton, Florida.

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"We are excited about the breadth of data we’re presenting at CTOS this year, which underscore the strong progress we continue to sustain across our pipeline," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "We look forward to sharing encore data from our Phase 3 MOTION study of vimseltinib and providing updates on our DCC-3009 Phase 1 program, which demonstrate how we can expand our GIST treatment capabilities by targeting known primary and secondary drug-resistant mutations spanning multiple KIT exons."

Oral and Poster presentation details are as follows:

Title: Long-Term Efficacy and Safety of Vimseltinib in Patients (Pts) with Tenosynovial Giant Cell Tumor (TGCT): Results from the MOTION Phase 3 Trial
Presenter: Silvia Stacchiotti, M.D., Fondazione IRCCS Istituto Nazionale Dei Tumori
Session Title: Session 8: TGCT & Desmoid Tumor
Session Date: Friday, November 14, 2025
Session Time: 2:30 – 3:30 PM ET

Title: Impact of Expert-Led Education Programs on Health Care Provider (HCP) Knowledge of Gastrointestinal Stromal Tumor (GIST)
Presenter: Mark Agulnik, M.D., USC Norris Comprehensive Cancer Center, University of Southern California
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

Title: Efficacy with Vimseltinib in Patients (Pts) with Tenosynovial Giant Cell Tumor (TGCT) and Prior Colony-Stimulating Factor 1 (CSF1) Inhibitor Therapy: A Phase 2 Case Series
Presenter: Andrew J. Wagner, M.D., Ph.D., Harvard Medical School, Dana-Farber Cancer Institute
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

Title: Effect of a High-Fat Meal on the Pharmacokinetics (PK) of Vimseltinib, an Oral Inhibitor of the Colony-Stimulating Factor 1 Receptor (CSF1), in Healthy Participants
Presenter: Chengyue Zhang, Ph.D., Deciphera Pharmaceuticals, LLC
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

Title: Effect of Itraconazole (ITX) and Rabeprazole (RBP) on the Pharmacokinetics (PK) of Vimseltinib, an Oral Inhibitor of the Colony-Stimulating Factor 1 Receptor (CSF1), in Healthy Participants
Presenter: Chengyue Zhang, Ph.D., Deciphera Pharmaceuticals, LLC
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

Title: An Open-Label Phase 1/2 Study of DCC-3009 Monotherapy in Patients (Pts) with Advanced Gastrointestinal Stromal Tumor (GIST)
Presenter: Suzanne George, M.D., Division of Sarcoma, Dana-Farber Cancer Institute – Sarcoma Center
Poster Reception: Thursday, November 13, 2025
Session Time: 5:30 – 6:30 PM ET

On November 12, 2025 Cogent Biosciences, Inc. ("Cogent") (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the pricing of its previously announced underwritten public offering of 9,677,420 shares of its common stock at a public offering price of $31.00 per share (such offering, the "Equity Offering") and its underwritten public offering of $200.0 million aggregate principal amount of its 1.625% convertible senior notes due 2031 (the "Convertible Notes" and such offering, the "Convertible Notes Offering"). The Equity Offering was upsized from the previously announced offering size of $200.0 million of shares of common stock.

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Cogent estimates that the net proceeds from the Equity Offering and the Convertible Notes Offering will be approximately $475.3 million, after deducting underwriting discounts and commissions and Cogent’s estimated offering expenses. In addition, Cogent has granted the underwriters of the Equity Offering a 30-day option to purchase up to an additional 1,451,613 shares of its common stock, on the same terms and conditions, and granted the underwriters of the Convertible Notes Offering a 30-day option to purchase up to an additional $30.0 million aggregate principal amount of Convertible Notes, solely to cover over-allotments in the Convertible Notes Offering, on the same terms and conditions.

The Equity Offering is expected to close on November 13, 2025, while the Convertible Notes Offering is expected to close on November 18, 2025, in each case, subject to satisfaction of customary closing conditions. The closing of neither the Equity Offering nor the Convertible Notes Offering is conditioned upon the closing of the other offering.

The Convertible Notes will be general, unsecured, senior obligations of Cogent. The Convertible Notes will accrue interest payable semi-annually in arrears on May 15 and November 15 of each year, beginning on May 15, 2026, at a rate equal to 1.625% per year. The Convertible Notes will mature on November 15, 2031, unless earlier converted, redeemed or repurchased by Cogent.

Before August 15, 2031, noteholders may convert their Convertible Notes at their option only in certain circumstances. At any time from, and including, August 15, 2031 until the close of business on the scheduled trading day immediately before the maturity date, the Convertible Notes will be convertible at the option of the holders. Cogent will settle conversions by paying or delivering, as applicable, cash, shares of its shares of its common stock, or a combination of cash and shares of its common stock, at Cogent’s election. The initial conversion rate is 22.2469 shares of its common stock, per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $44.95 per share of common stock and represents a conversion premium of approximately 45.0% above the public offering price per share of common stock in the Equity Offering. If a "make-whole fundamental change" (as defined in the indenture that will govern the Convertible Notes) occurs, then Cogent will in certain circumstances increase the conversion rate for a specified period of time.

The Convertible Notes will be redeemable, in whole or in part (subject to certain limitations), at Cogent’s option at any time, and from time to time, on a redemption date on or after November 20, 2029 and on or before the 26th scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion price for the Convertible Notes on (1) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date Cogent sends the related redemption notice; and (2) the trading day immediately before the date Cogent sends such notice.

If a "fundamental change" (as defined in the indenture that will govern the Convertible Notes) occurs, then, subject to certain exceptions, noteholders may require Cogent to repurchase their Convertible Notes at a cash repurchase price equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.

Cogent intends to use the net proceeds from the Equity Offering and the Convertible Notes Offering to repay $50 million of loans outstanding under its existing term loan facility, plus accrued interest and associated fees, and the remainder for development and regulatory activities relating to bezuclastinib and other product candidates, the anticipated commercial launch and commercialization of bezuclastinib, as well as for working capital and general corporate purposes.

J.P. Morgan, Jefferies, Leerink Partners and Guggenheim Securities are acting as joint-book running managers for the Equity Offering. LifeSci Capital is acting as lead manager and Raymond James is acting as co-manager for the Equity Offering.

Jefferies and J.P. Morgan are acting as joint book-running managers for the Convertible Notes Offering.

The securities described above are being offered pursuant to an automatic shelf registration statement on Form S-3ASR (File No. 333-291384), which was filed with the Securities and Exchange Commission ("SEC") on November 7, 2025 and automatically became effective upon filing.

Preliminary prospectus supplements and the accompanying base prospectuses relating to and describing the terms of each offering were filed with the SEC on November 10, 2025 and are expected to be available on the SEC’s website on November 12, 2025. Final prospectus supplements and the accompanying base prospectuses relating to and describing the terms of each offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offerings can be made only by means of prospectus supplements and accompanying base prospectuses, copies of which may each be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Ave., New York, NY 10017, or by telephone at (212) 518-9544, or by email at [email protected].

(Press release, Cogent Biosciences, NOV 12, 2025, View Source [SID1234659753])

On November 12, 2025 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, reported financial results for the third quarter ended September 30, 2025.

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"This quarter, we continued to execute across a diverse pipeline spanning multiple, potentially high impact projects in infectious diseases and oncology, leveraging our boron chemistry platform to address areas of high unmet need. These programs reflect our commitment to delivering transformative therapies, each having potential to meaningfully add shareholder value within our cash runway," said Eric Easom, Co-Founder, Chairman, President and CEO of AN2 Therapeutics. "Our program studying oral AN2-502998 for Chagas disease is progressing through a Phase 1 first-in-human clinical trial, and planning for a subsequent Phase 2 proof-of-concept study is underway with our collaborators at Drugs for Neglected Diseases initiative (DNDi). In oncology, we expect our two lead programs to enter development in 2026, each with the potential to meaningfully impact solid-tumor cancers. We’ve also entered into a collaboration with GSK focused on TB, where our work is supported by a third year of funding from the Gates Foundation. This initiative reflects our commitment to applying boron chemistry to a disease that continues to impact a quarter of the world’s population."

Third Quarter & Recent Business Updates:

Chagas Disease

Advancing Phase 1 first-in-human clinical trial of oral AN2-502998

The Company is progressing through a Phase 1 first-in-human clinical trial evaluating the safety, tolerability, and pharmacokinetics of oral AN2-502998 in healthy volunteers. Oral AN2-502998 is under development for chronic Chagas disease, an infectious disease caused by the parasite Trypanosoma cruzi (T. cruzi), which affects an estimated 6-7 million people worldwide, including approximately 300,000 in the U.S. and over 100,000 in Europe. AN2-502998 is the only compound of which the Company is aware to have demonstrated curative activity in preclinical studies across multiple species, including in nonhuman primates (NHP) with long-term, naturally acquired chronic infections of diverse T. cruzi genetic types. Because NHP infections are naturally acquired in the environment, this efficacy data may be more predictive of efficacy in human clinical trials than other animal models. The Company anticipates Phase 1 data in the first quarter of 2026 and initiation of a Phase 2 proof-of-concept study in patients with chronic Chagas disease in 2026, depending upon the outcome and timing of completion of the Phase 1 study. Through the Company’s collaboration with DNDi, the company will leverage DNDi’s extensive clinical trial network and expertise in Chagas disease to rapidly advance the clinical development of AN2-502998. There are no FDA approved treatments for adults with chronic Chagas disease.
Boron Chemistry Pipeline

Continuing to advance boron chemistry compounds in oncology

The Company is pursuing a number of oncology targets where we believe boron chemistry offers a competitive advantage in terms of binding-site differentiation, pharmacodynamics, drug-like properties and IP, including initially ENPP1 and PI3Kα. The unique binding modes of boron-containing compounds enable the discovery of inhibitors with high ligand efficiency against targets considered undruggable or difficult to access with traditional chemistry approaches. Boron chemistry has produced first-in-class molecules against a number of targets including CPSF3 (AN2-502998 and acoziborole) and LeuRS (epetraborole, ganfeborole and tavaborole). The Company has discovered preclinical compounds with profiles that are sub-nanomolar, highly selective and with strong oral pharmacokinetics. The Company anticipates advancing the first oncology compound into development in early 2026 with potential clinical proof-of-concept data within the Company’s current cash runway. The Company expects to advance its second oncology compound into development in mid-2026.
Nontuberculous Mycobacteria (NTM) Lung Disease Caused by M. abscessus

M. abscessus program advancing through investigator-initiated trial (IIT)

Building on the microbiological and safety data from the Company’s prior NTM study, the Company believes that epetraborole has the potential to address a critical unmet need in M. abscessus lung disease, one of the most difficult to treat NTM infections for which no FDA-approved therapies exist. The Company is supporting the design of an IIT expected to begin enrollment in early 2026, pending finalization of the trial protocol and regulatory allowance to proceed. The Company anticipates that data from this potential study, if positive, could provide the clinical evidence of human proof of concept in M. abscessus and inform the design of a subsequent pivotal trial. NTM lung disease represents a growing global health concern. It is estimated that approximately 120,000–150,000 people in the U.S. are living with NTM lung disease, of which 10–15% are caused by M. abscessus.
Melioidosis

Preparing for epetraborole’s next phase of development in acute melioidosis, a highly lethal bacterial infection and recognized biothreat

AN2 is developing epetraborole for the treatment of acute melioidosis, a highly lethal bacterial infection and recognized biothreat. The Company completed enrollment in a 200-patient observational trial (non-epetraborole treatment) in October 2024, and in June 2025 announced key insights from the trial, which reinforce the high mortality of the disease, despite standard of care. This study provided critical data which will allow the Company to optimize the design of upcoming clinical studies. Discussions are underway with the U.S. government to fund Phase 2 development of epetraborole in acute melioidosis. Melioidosis has a 90-day mortality rate approaching 40%, despite standard of care (SOC) drugs, including ceftazidime or meropenem. The aim of the program is to meaningfully lower the expected mortality rate by dosing epetraborole on top of standard of care. If approved for the treatment of melioidosis, the Company plans to seek a priority review voucher and could generate revenue from U.S. and other governmental stockpiling, as well as from use as treatment in disease-endemic countries, including the U.S.
Global Health

Research collaboration with GSK to advance boron-based LeuRS-inhibitors targeting TB; AN2 awarded third year funding from Gates Foundation

In November 2025, the Company announced a collaboration with the global biopharma company GSK to develop new therapies for TB. As part of this effort, the Gates Foundation will provide a third year of funding to support AN2’s work within the collaboration. TB continues to pose a major global health challenge, affecting more than a quarter of the world’s population and causing over 1.25 million deaths annually.
Selected Third Quarter Financial Results

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $7.0 million, compared to $8.3 million for the same period during 2024 due to decreased clinical trial expenses, personnel-related expenses, chemistry manufacturing and controls expenses, and consulting and outside services, primarily related to termination of the EBO-301 clinical study and corporate restructuring activities in August 2024. These decreases were partially offset by increases in preclinical and research studies and expenses related to start-up activities of the Phase 1 trial in Chagas disease and facility and other expenses.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $3.0 million, compared to $3.5 million for the same period during 2024 due to decreased personnel-related expenses, professional and outside services expenses, and other expenses.
Restructuring Charges: There were no restructuring charges in the third quarter of 2025. Restructuring charges for the third quarter of 2024 were $2.2 million due to severance payments and other employee termination-related expenses.
Interest Income: Interest income for the third quarter of 2025 was $0.7 million, compared to $1.3 million for the same period in 2024 due to lower cash, cash equivalents and investment balances and lower interest rates in 2025 as compared to 2024.
Net Loss: Net loss for the third quarter of 2025 was $9.4 million, compared to $12.7 million for the same period during 2024.
Cash Position: The Company had cash, cash equivalents and investments of $65.1 million at September 30, 2025. The Company projects that existing cash, cash equivalents and investments will sustain operations into 2028 under the current operating plan.

(Press release, AN2 Therapeutics, NOV 12, 2025, View Source [SID1234659803])