Protara Announces Closing of $75 Million Public Offering




Protara Announces Closing of $75 Million Public Offering

NEW YORK, Dec. 08, 2025 (GLOBE NEWSWIRE) — Protara Therapeutics, Inc. (Nasdaq: TARA) (“Protara”), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced the closing of its underwritten public offering of 13,043,479 shares of its common stock at a public offering price of $5.75 per share. In addition, Protara has granted the underwriters a 30-day option to purchase up to an additional 1,956,521 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering were approximately $75 million before deducting underwriting discounts and commissions and offering expenses payable by Protara and excluding any exercise of the underwriters’ option to purchase additional shares. Protara intends to use the net proceeds received from the offering to fund the clinical development of TARA-002, as well as the development of other clinical programs. Protara may also use the net proceeds from the offering for working capital and other general corporate purposes.

J.P. Morgan, TD Cowen and Piper Sandler acted as joint book-running managers of the offering. LifeSci Capital acted as a lead manager of the offering. H.C. Wainwright & Co. acted as a manager of the offering.

The shares of common stock were issued pursuant to an effective shelf registration statement on Form S-3 (File No. 333-275290) that was declared effective on November 14, 2023 by the U.S. Securities and Exchange Commission (the “SEC”). The offering was made only by means of a prospectus supplement and the accompanying prospectus. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from the offices of J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or by email at TDManualrequest@broadridge.com; or Piper Sandler & Co., 350 North 5^th Street, Suite 1000, Minneapolis, Minnesota 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at prospectus@psc.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the expected use of proceeds from the offering, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the uncertain nature of the forward-looking statements include: Protara’s expectations related to the use of proceeds from the offering. Additional important factors to be considered in connection with forward-looking statements, including additional risks and uncertainties, are described more fully under the caption “Risk Factors” and elsewhere in Protara’s filings and reports with the SEC. 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. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law.

Company Contact:
Justine O’Malley
Protara Therapeutics
Justine.OMalley@protaratx.com
646-817-2836

Assembly Biosciences Reports Positive Interim Results from Phase 1b Clinical Studies of Long-Acting Helicase-Primase Inhibitor Candidates ABI-1179 and ABI-5366 Showing Reductions in Viral Shedding Rate and Virologically Confirmed Genital Lesion Rate in Recurrent Genital Herpes




Assembly Biosciences Reports Positive Interim Results from Phase 1b Clinical Studies of Long-Acting Helicase-Primase Inhibitor Candidates ABI-1179 and ABI-5366 Showing Reductions in Viral Shedding Rate and Virologically Confirmed Genital Lesion Rate in Recurrent Genital Herpes

– 98% reduction in HSV-2 shedding rate, >99% reduction in high viral load shedding rate and 91% reduction in virologically confirmed genital lesion rate observed in 50 mg weekly oral dose of ABI-1179, exceeding expectations for the study –

– 76% reduction in HSV-2 shedding rate, 81% reduction in high viral load shedding rate and 88% reduction in virologically confirmed genital lesion rate observed in proof-of-concept test of monthly oral dose of ABI-5366 –

– Company to hold conference call today at 6 p.m. ET –

SOUTH SAN FRANCISCO, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) — Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced positive interim results from two Phase 1b studies of its investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitors in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes. These interim results include the first reported Phase 1b data for ABI-1179, evaluating weekly oral dosing. For ABI-5366, the reported data is for a monthly oral dosing regimen, following the positive interim results for weekly oral dosing reported earlier this year.

“As we saw with ABI-5366, weekly oral dosing of ABI-1179 outperformed our expectations for antiviral efficacy and improvement in clinical outcomes, and we are thrilled with these Phase 1b findings for both highly promising candidates,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “The ABI-5366 monthly oral dosing results are also encouraging and show significant reductions in viral shedding and virologically confirmed genital lesion rate, supporting the continued optimization of exposure to evaluate its potential for monthly oral dosing. We expect to pursue such optimization efforts in parallel with moving once-weekly ABI-5366 regimens into longer-duration Phase 2 clinical studies, which we plan to initiate in mid-2026. In parallel, we are evaluating the potential to also advance ABI-1179 into Phase 2 clinical evaluation and are progressing Phase 2 enabling activities for this candidate.”

In the ABI-1179 study, highly potent antiviral activity was observed with a 98% reduction in HSV-2 shedding rate compared to placebo (p<0.01) over the 29-day evaluation period in the 50 mg weekly dose cohort. This reduction exceeds Assembly Bio’s target for the study of an 80%-85% reduction in HSV-2 shedding rate. Further, data revealed a 91% reduction in virologically confirmed genital lesion rate compared to placebo (p<0.01) with the 50 mg weekly dose. There was also a >99% reduction in the number of samples with high viral load, a potential surrogate for HSV-2 transmission and a secondary endpoint. ABI-1179 was observed to be well-tolerated at oral doses up to 50 mg weekly and the observed pharmacokinetic (PK) profile continues to support once-weekly oral dosing regimens.

In the ABI-5366 monthly dose cohort, potent antiviral activity was observed, with a 76% reduction in HSV-2 shedding rate compared to placebo (p<0.01) over the 29-day evaluation period. The majority of positive swabs (89%) were collected in the last two weeks of the evaluation period when drug levels were declining. An 88% reduction in virologically confirmed genital lesion rate (p=0.01), along with an 81% reduction in the number of samples with high viral load (p<0.01) compared to placebo, was observed. As previously reported for the 350 mg weekly dose cohort, a 94% reduction in HSV-2 shedding rate (p<0.01) and a 97% reduction in virologically confirmed genital lesion rate (p<0.05) compared to placebo was observed. ABI-5366 continues to be well-tolerated across all evaluated oral dosing regimens up to 350 mg weekly, and the PK profile supports both once-weekly and potentially once-monthly oral dosing regimens.

Under the collaboration agreement between Assembly Bio and Gilead Sciences, Inc. (Gilead), Gilead has the right to opt in to an exclusive license for further development and commercialization of the helicase-primase inhibitor program, with the first option timepoint extending through the review of an option data package to be delivered by Assembly Bio following the end of the Phase 1b studies.

ABI-1179 was contributed by Gilead under the collaboration between Assembly Bio and Gilead. ABI-5366 and ABI-1179 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established.

Study ABI-1179-101 – Interim Phase 1b Results

Interim Results

The Phase 1b interim analysis includes data from cohort B1, evaluating a 50 mg weekly oral dose and cohort B2, evaluating a 20 mg weekly oral dose, through the data cutoff date of November 25, 2025.

Fifty participants have been enrolled in the 50 mg and 20 mg cohorts; 40 assigned to ABI-1179 (20 participants in each cohort) and 10 assigned to placebo (five in each cohort). Forty-six participants from these cohorts have completed the 29-day evaluation period while three discontinued treatment; one discontinued due to being lost to follow-up and two for other reasons not related to adverse events or study treatment. One participant was enrolled in the 20 mg cohort but did not receive treatment.

Antiviral activity and clinical outcomes by treatment arm are summarized below. For this analysis, Assembly Bio also looked at whether participant-reported lesions were confirmed with any positive HSV-2 swab taken during the duration of the reported lesion. Both virologically confirmed and overall lesion rates are provided for both ABI-1179 and ABI-5366 studies. 

PBO=placebo; QW=once weekly; SD=standard deviation. All outcomes measured over evaluation period.
^a HSV-2 shedding rate calculated as the number of positive HSV-2 anogenital swabs divided by the total number of swabs collected.
^b High viral load shedding rate calculated as the number of positive HSV-2 anogenital swabs with HSV-2 >10⁴ copies/mL divided by the total number of swabs collected.
 ^c Overall genital lesion rate calculated as the number of days with genital lesions of any kind present (including non HSV-2-associated lesions) divided by the total number of days assessed.
^d Virologically confirmed lesion rate calculated as the number of days with genital lesions associated with positive HSV-2 anogenital swabs present divided by the total number of days assessed.

Statistically significant reductions were observed in the viral shedding rate, high viral load shedding rate, and virologically confirmed genital lesion rate for both the 50 mg and 20 mg cohorts compared to placebo as summarized below.

PBO=placebo; QW=once weekly; High viral load = >10⁴ HSV DNA copies/mL
^a Statistical analysis conducted using Poisson regression models and the corresponding p-values estimated accordingly.
^b P-value cannot be reliably calculated given the >99% reduction compared to placebo. The observed difference is consistent with a highly significant effect.

Across the 50 mg and 20 mg cohorts, ABI-1179 demonstrated a PK profile that continues to support once-weekly dosing. ABI-1179 was observed to be well-tolerated at oral doses up to 50 mg weekly in participants seropositive for HSV-2 with recurrent genital herpes.

As the study is ongoing, individual treatment assignments remain blinded. Overall, the proportion of participants reporting treatment-emergent adverse events (TEAEs) was similar between ABI-1179 (80%) and placebo (88.9%) recipients. Of the TEAEs reported, the majority were grade 1 or grade 2. The most common adverse events were upper respiratory tract infections and headaches. There have been no serious adverse events reported to date. One grade 3 adverse event of migraine was reported in a participant enrolled in the 20 mg/placebo cohort.

The proportion of participants reporting treatment-emergent laboratory abnormalities was higher in placebo (44.4%) than in ABI-1179 (32.5%) recipients, with all observed abnormalities grade 1 or grade 2.

Study ABI-5366-101 – Interim Phase 1b Monthly Dosing Results

Interim Results

The Phase 1b interim monthly dosing cohort analysis includes data from cohort B3, evaluating five loading doses of 350 mg given over seven days (the monthly cohort) through the data cutoff date of November 25, 2025. After this loading dose period, the evaluation period extended for 29 days with no further dosing as a simulation of a monthly dosing regimen. Additionally, final unblinded data from cohort B1, evaluating a loading dose of 150 mg and weekly doses of 30 mg (the 150/30 mg cohort), and cohort B2, evaluating a loading dose and weekly doses of 350 mg (the 350 mg cohort), are included.

Seventy-six participants have been enrolled in the 150/30 mg, 350 mg and the monthly cohorts; 61 assigned to ABI-5366 (20 participants in each of the 150/30 mg and 350 mg cohorts, 21 in the monthly cohort) and 15 assigned to placebo (five in each cohort). Sixty-nine participants from these cohorts have completed the 29-day evaluation period while seven discontinued treatment; one due to an adverse event (described below), one due to follow-up, two withdrew consent and three for other reasons not related to adverse events or study treatment.

Antiviral activity and clinical outcomes by treatment arm are summarized below.

PBO=placebo; QW=once weekly; SD=standard deviation; High viral load = >10⁴ HSV DNA copies/mL. All outcomes measured over evaluation period.
^a HSV-2 shedding rate calculated as the number of positive HSV-2 anogenital swabs divided by the total number of swabs collected.
^b High viral load shedding rate calculated as the number of positive HSV-2 anogenital swabs with HSV-2 >10⁴ copies/mL divided by the total number of swabs collected.
 ^c Overall genital lesion rate calculated as the number of days with genital lesions of any kind present (including non HSV-2 associated lesions) divided by the total number of days assessed.
^d Virologically confirmed lesion rate calculated as the number of days with genital lesions associated with positive HSV-2 anogenital swabs present divided by the total number of days assessed.

Statistically significant reductions were observed in the viral shedding rate, high viral load shedding rate, overall genital lesion rate and virologically confirmed genital lesion rate for both the 350 mg QW and monthly cohorts compared to placebo as summarized below. 

PBO=placebo; QW=once weekly; High viral load = >10⁴ HSV DNA copies/mL
^a Statistical analysis conducted using Poisson regression models and the corresponding p-values estimated accordingly.

Across the 150/30 mg, 350 mg QW and monthly cohorts, ABI-5366 demonstrated a PK profile that continues to be supportive of once-weekly and potentially once-monthly dosing.

ABI-5366 was observed to be well-tolerated at all dose levels tested in participants seropositive for HSV-2 with recurrent genital herpes. While cohorts B1 and B2 are complete and unblinded safety data are reported, cohort B3 is ongoing and data remains blinded for this cohort. Safety data are summarized below.

PBO=placebo; QW=once weekly

Overall, across all cohorts, the proportion of participants reporting TEAEs was similar between ABI-5366 (95.1%) and placebo (93.3%) recipients. Of the TEAEs reported, all were grade 1 or grade 2. One grade 3 adverse event of hypertriglyceridemia was reported in a participant with relevant medical history who had grade 4 elevated triglycerides pre-dose on Day 1. This adverse event resulted in study discontinuation but following closure of the cohort was reassessed and was not considered treatment emergent or treatment related.

The proportion of participants reporting treatment emergent laboratory abnormalities was similar in placebo (66.7%) and ABI-5366 (68.9%) recipients, with the majority of observed abnormalities being grade 1 or grade 2.

There were three participants with treatment-emergent grade 3 laboratory abnormalities, all in the unblinded cohorts B1 and B2, and all are considered unrelated to assigned treatment: an exercise-associated elevation in creatine kinase (150/30 mg QW), an elevation of cholesterol in the follow-up period in a participant that had a grade 2 elevation at baseline (350 mg QW) and a participant with decreased neutrophils (placebo). There did not appear to be a dose-response relationship in either the frequency or severity of TEAEs or laboratory abnormalities. There have been no serious adverse events reported to date.

ABI-1179-101 Study Overview

ABI-1179-101 is a randomized, blinded, placebo-controlled Phase 1a/b clinical study. Positive interim data have been previously reported for Part A (Phase 1a), evaluating the safety, tolerability and PK of ABI-1179 following single dose administration in healthy participants. Part B (Phase 1b), in participants seropositive for HSV-2 with recurrent genital herpes, is evaluating weekly oral dosing regimens over a 29-day period in up to four cohorts randomized 20:5 between ABI-1179 and placebo with a pooled placebo analysis. Dosing is ongoing for cohort B3, evaluating a 10 mg weekly dosing regimen of ABI-1179. Part B also evaluates antiviral activity by measuring changes in viral parameters including shedding rate, quantification of HSV-2 DNA levels obtained from anogenital swab samples, and clinical parameters including genital lesion rate and duration. Due to the observed half-life of ABI-1179, the safety follow-up period for participants extends for 29 days after dosing (Day 57), with safety data available as of the data cutoff date through Day 57 for all participants from these cohorts that completed the evaluation period. The study uses pooled data from placebo recipients across cohorts as a control. As additional placebo recipients are enrolled in later cohorts, the sample size for the pooled placebos will change, which is expected to result in adjustments to both the observed effect sizes compared to placebo and the tests of statistical significance for those observed effects.

Additional information about the Phase 1a/b trial is available at clinicaltrials.gov using the identifier NCT06698575.

ABI-5366-101 Study Overview

ABI-5366-101 is a randomized, blinded, placebo-controlled Phase 1a/b clinical study. Positive interim data have been previously reported for Part A (Phase 1a), evaluating the safety, tolerability and PK of ABI-5366 following single dose administration in healthy participants. Positive interim data have also previously been reported for two weekly oral dosing regimens over a 29-day period in Part B (Phase 1b, cohorts B1 and B2), in participants seropositive for HSV-2 with recurrent genital herpes. Part B of the study enrolled three cohorts randomized 20:5 between ABI-5366 and placebo with a pooled placebo analysis. Safety follow up is ongoing for cohort B3. Part B also evaluates antiviral activity by measuring changes in viral parameters including shedding rate, quantification of HSV-2 DNA levels obtained from anogenital swab samples, and clinical parameters including genital lesion rate and duration. Due to the long half-life of ABI-5366, the safety follow-up period for participants extends for 98 days after dosing (Day 127), with all safety data available as of the data cutoff date for all participants in cohorts B1 and B2 and up to Day 43 for all participants from the B3 cohort that completed the evaluation period. Complete, unblinded safety data are included for cohorts B1 and B2, with blinded safety data for cohort B3. The study uses pooled data from placebo recipients across cohorts as a control. As additional data for placebo recipients from cohort B3 become available, it is expected to result in adjustments to both the observed effect sizes compared to placebo and the tests of statistical significance for those observed effects.

Additional information about the Phase 1a/b trial is available at clinicaltrials.gov using the identifier NCT06385327.

Webcast and Conference Call Information

Assembly Bio will be hosting a live webcast today at 6 p.m. ET. The live webcast can be accessed on the Investors section on the Company’s website at https://investor.assemblybio.com/events-presentations. A replay of the webcast will be available following the call.

About Recurrent Genital Herpes

Genital herpes is a chronic viral infection caused by HSV that can result in painful genital lesions, serious psychological and social impacts, and an increased risk of acquiring human immunodeficiency virus (HIV). Epidemiologic studies estimate over four million people in the United States, France, Germany, Italy, Spain and the United Kingdom experience recurrent genital herpes, with most people with initial symptomatic genital HSV-2 infection having three or more recurrences per year. While genital herpes can be caused by either HSV type 1 (HSV-1) or HSV-2, recurrences are more likely to be experienced by individuals infected by HSV-2. The current standard of care for recurrent genital herpes is nucleoside analogs given intermittently for recurrences or as daily chronic suppressive therapy; however, these are only partially effective in preventing recurrences and in reducing transmission of the virus. No new drugs have been approved in the United States or Europe to treat genital herpes for more than 25 years.

About Helicase-Primase Inhibition

HSV helicase-primase inhibitors target the viral helicase-primase complex, an essential viral enzyme complex that is conserved across both HSV-1 and HSV-2 and has no host equivalent. Inhibition of the helicase-primase complex is a clinically validated mechanism that has shown the potential for superior efficacy to the current standard of care, nucleoside analogs, in short-duration clinical studies in participants with recurrent genital herpes.

About Assembly Biosciences

Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com.

Forward-Looking Statements

The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data may not differentiate Assembly Bio’s product candidates from other companies’ candidates; Assembly Bio’s ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; potential effects of changes in government regulation, including as a result of the change in U.S. administration in 2025; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Investors:
Meru Advisors
Patrick Till
(415) 788-8560
investor_relations@assemblybio.com

Media:
Sam Brown LLC
Alyssa Kuciunas
(331) 481-3751
ASMBMedia@sambrown.com

Assembly Biosciences Reports Positive Interim Results from Phase 1b Clinical Studies of Long-Acting Helicase-Primase Inhibitor Candidates ABI-1179 and ABI-5366 Showing Reductions in Viral Shedding Rate and Virologically Confirmed Genital Lesion Rate in Recurrent Genital Herpes




Assembly Biosciences Reports Positive Interim Results from Phase 1b Clinical Studies of Long-Acting Helicase-Primase Inhibitor Candidates ABI-1179 and ABI-5366 Showing Reductions in Viral Shedding Rate and Virologically Confirmed Genital Lesion Rate in Recurrent Genital Herpes

– 98% reduction in HSV-2 shedding rate, >99% reduction in high viral load shedding rate and 91% reduction in virologically confirmed genital lesion rate observed in 50 mg weekly oral dose of ABI-1179, exceeding expectations for the study –

– 76% reduction in HSV-2 shedding rate, 81% reduction in high viral load shedding rate and 88% reduction in virologically confirmed genital lesion rate observed in proof-of-concept test of monthly oral dose of ABI-5366 –

– Company to hold conference call today at 6 p.m. ET –

SOUTH SAN FRANCISCO, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) — Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced positive interim results from two Phase 1b studies of its investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitors in participants seropositive for HSV type 2 (HSV-2) with recurrent genital herpes. These interim results include the first reported Phase 1b data for ABI-1179, evaluating weekly oral dosing. For ABI-5366, the reported data is for a monthly oral dosing regimen, following the positive interim results for weekly oral dosing reported earlier this year.

“As we saw with ABI-5366, weekly oral dosing of ABI-1179 outperformed our expectations for antiviral efficacy and improvement in clinical outcomes, and we are thrilled with these Phase 1b findings for both highly promising candidates,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “The ABI-5366 monthly oral dosing results are also encouraging and show significant reductions in viral shedding and virologically confirmed genital lesion rate, supporting the continued optimization of exposure to evaluate its potential for monthly oral dosing. We expect to pursue such optimization efforts in parallel with moving once-weekly ABI-5366 regimens into longer-duration Phase 2 clinical studies, which we plan to initiate in mid-2026. In parallel, we are evaluating the potential to also advance ABI-1179 into Phase 2 clinical evaluation and are progressing Phase 2 enabling activities for this candidate.”

In the ABI-1179 study, highly potent antiviral activity was observed with a 98% reduction in HSV-2 shedding rate compared to placebo (p<0.01) over the 29-day evaluation period in the 50 mg weekly dose cohort. This reduction exceeds Assembly Bio’s target for the study of an 80%-85% reduction in HSV-2 shedding rate. Further, data revealed a 91% reduction in virologically confirmed genital lesion rate compared to placebo (p<0.01) with the 50 mg weekly dose. There was also a >99% reduction in the number of samples with high viral load, a potential surrogate for HSV-2 transmission and a secondary endpoint. ABI-1179 was observed to be well-tolerated at oral doses up to 50 mg weekly and the observed pharmacokinetic (PK) profile continues to support once-weekly oral dosing regimens.

In the ABI-5366 monthly dose cohort, potent antiviral activity was observed, with a 76% reduction in HSV-2 shedding rate compared to placebo (p<0.01) over the 29-day evaluation period. The majority of positive swabs (89%) were collected in the last two weeks of the evaluation period when drug levels were declining. An 88% reduction in virologically confirmed genital lesion rate (p=0.01), along with an 81% reduction in the number of samples with high viral load (p<0.01) compared to placebo, was observed. As previously reported for the 350 mg weekly dose cohort, a 94% reduction in HSV-2 shedding rate (p<0.01) and a 97% reduction in virologically confirmed genital lesion rate (p<0.05) compared to placebo was observed. ABI-5366 continues to be well-tolerated across all evaluated oral dosing regimens up to 350 mg weekly, and the PK profile supports both once-weekly and potentially once-monthly oral dosing regimens.

Under the collaboration agreement between Assembly Bio and Gilead Sciences, Inc. (Gilead), Gilead has the right to opt in to an exclusive license for further development and commercialization of the helicase-primase inhibitor program, with the first option timepoint extending through the review of an option data package to be delivered by Assembly Bio following the end of the Phase 1b studies.

ABI-1179 was contributed by Gilead under the collaboration between Assembly Bio and Gilead. ABI-5366 and ABI-1179 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established.

Study ABI-1179-101 – Interim Phase 1b Results

Interim Results

The Phase 1b interim analysis includes data from cohort B1, evaluating a 50 mg weekly oral dose and cohort B2, evaluating a 20 mg weekly oral dose, through the data cutoff date of November 25, 2025.

Fifty participants have been enrolled in the 50 mg and 20 mg cohorts; 40 assigned to ABI-1179 (20 participants in each cohort) and 10 assigned to placebo (five in each cohort). Forty-six participants from these cohorts have completed the 29-day evaluation period while three discontinued treatment; one discontinued due to being lost to follow-up and two for other reasons not related to adverse events or study treatment. One participant was enrolled in the 20 mg cohort but did not receive treatment.

Antiviral activity and clinical outcomes by treatment arm are summarized below. For this analysis, Assembly Bio also looked at whether participant-reported lesions were confirmed with any positive HSV-2 swab taken during the duration of the reported lesion. Both virologically confirmed and overall lesion rates are provided for both ABI-1179 and ABI-5366 studies. 

PBO=placebo; QW=once weekly; SD=standard deviation. All outcomes measured over evaluation period.
^a HSV-2 shedding rate calculated as the number of positive HSV-2 anogenital swabs divided by the total number of swabs collected.
^b High viral load shedding rate calculated as the number of positive HSV-2 anogenital swabs with HSV-2 >10⁴ copies/mL divided by the total number of swabs collected.
 ^c Overall genital lesion rate calculated as the number of days with genital lesions of any kind present (including non HSV-2-associated lesions) divided by the total number of days assessed.
^d Virologically confirmed lesion rate calculated as the number of days with genital lesions associated with positive HSV-2 anogenital swabs present divided by the total number of days assessed.

Statistically significant reductions were observed in the viral shedding rate, high viral load shedding rate, and virologically confirmed genital lesion rate for both the 50 mg and 20 mg cohorts compared to placebo as summarized below.

PBO=placebo; QW=once weekly; High viral load = >10⁴ HSV DNA copies/mL
^a Statistical analysis conducted using Poisson regression models and the corresponding p-values estimated accordingly.
^b P-value cannot be reliably calculated given the >99% reduction compared to placebo. The observed difference is consistent with a highly significant effect.

Across the 50 mg and 20 mg cohorts, ABI-1179 demonstrated a PK profile that continues to support once-weekly dosing. ABI-1179 was observed to be well-tolerated at oral doses up to 50 mg weekly in participants seropositive for HSV-2 with recurrent genital herpes.

As the study is ongoing, individual treatment assignments remain blinded. Overall, the proportion of participants reporting treatment-emergent adverse events (TEAEs) was similar between ABI-1179 (80%) and placebo (88.9%) recipients. Of the TEAEs reported, the majority were grade 1 or grade 2. The most common adverse events were upper respiratory tract infections and headaches. There have been no serious adverse events reported to date. One grade 3 adverse event of migraine was reported in a participant enrolled in the 20 mg/placebo cohort.

The proportion of participants reporting treatment-emergent laboratory abnormalities was higher in placebo (44.4%) than in ABI-1179 (32.5%) recipients, with all observed abnormalities grade 1 or grade 2.

Study ABI-5366-101 – Interim Phase 1b Monthly Dosing Results

Interim Results

The Phase 1b interim monthly dosing cohort analysis includes data from cohort B3, evaluating five loading doses of 350 mg given over seven days (the monthly cohort) through the data cutoff date of November 25, 2025. After this loading dose period, the evaluation period extended for 29 days with no further dosing as a simulation of a monthly dosing regimen. Additionally, final unblinded data from cohort B1, evaluating a loading dose of 150 mg and weekly doses of 30 mg (the 150/30 mg cohort), and cohort B2, evaluating a loading dose and weekly doses of 350 mg (the 350 mg cohort), are included.

Seventy-six participants have been enrolled in the 150/30 mg, 350 mg and the monthly cohorts; 61 assigned to ABI-5366 (20 participants in each of the 150/30 mg and 350 mg cohorts, 21 in the monthly cohort) and 15 assigned to placebo (five in each cohort). Sixty-nine participants from these cohorts have completed the 29-day evaluation period while seven discontinued treatment; one due to an adverse event (described below), one due to follow-up, two withdrew consent and three for other reasons not related to adverse events or study treatment.

Antiviral activity and clinical outcomes by treatment arm are summarized below.

PBO=placebo; QW=once weekly; SD=standard deviation; High viral load = >10⁴ HSV DNA copies/mL. All outcomes measured over evaluation period.
^a HSV-2 shedding rate calculated as the number of positive HSV-2 anogenital swabs divided by the total number of swabs collected.
^b High viral load shedding rate calculated as the number of positive HSV-2 anogenital swabs with HSV-2 >10⁴ copies/mL divided by the total number of swabs collected.
 ^c Overall genital lesion rate calculated as the number of days with genital lesions of any kind present (including non HSV-2 associated lesions) divided by the total number of days assessed.
^d Virologically confirmed lesion rate calculated as the number of days with genital lesions associated with positive HSV-2 anogenital swabs present divided by the total number of days assessed.

Statistically significant reductions were observed in the viral shedding rate, high viral load shedding rate, overall genital lesion rate and virologically confirmed genital lesion rate for both the 350 mg QW and monthly cohorts compared to placebo as summarized below. 

PBO=placebo; QW=once weekly; High viral load = >10⁴ HSV DNA copies/mL
^a Statistical analysis conducted using Poisson regression models and the corresponding p-values estimated accordingly.

Across the 150/30 mg, 350 mg QW and monthly cohorts, ABI-5366 demonstrated a PK profile that continues to be supportive of once-weekly and potentially once-monthly dosing.

ABI-5366 was observed to be well-tolerated at all dose levels tested in participants seropositive for HSV-2 with recurrent genital herpes. While cohorts B1 and B2 are complete and unblinded safety data are reported, cohort B3 is ongoing and data remains blinded for this cohort. Safety data are summarized below.

PBO=placebo; QW=once weekly

Overall, across all cohorts, the proportion of participants reporting TEAEs was similar between ABI-5366 (95.1%) and placebo (93.3%) recipients. Of the TEAEs reported, all were grade 1 or grade 2. One grade 3 adverse event of hypertriglyceridemia was reported in a participant with relevant medical history who had grade 4 elevated triglycerides pre-dose on Day 1. This adverse event resulted in study discontinuation but following closure of the cohort was reassessed and was not considered treatment emergent or treatment related.

The proportion of participants reporting treatment emergent laboratory abnormalities was similar in placebo (66.7%) and ABI-5366 (68.9%) recipients, with the majority of observed abnormalities being grade 1 or grade 2.

There were three participants with treatment-emergent grade 3 laboratory abnormalities, all in the unblinded cohorts B1 and B2, and all are considered unrelated to assigned treatment: an exercise-associated elevation in creatine kinase (150/30 mg QW), an elevation of cholesterol in the follow-up period in a participant that had a grade 2 elevation at baseline (350 mg QW) and a participant with decreased neutrophils (placebo). There did not appear to be a dose-response relationship in either the frequency or severity of TEAEs or laboratory abnormalities. There have been no serious adverse events reported to date.

ABI-1179-101 Study Overview

ABI-1179-101 is a randomized, blinded, placebo-controlled Phase 1a/b clinical study. Positive interim data have been previously reported for Part A (Phase 1a), evaluating the safety, tolerability and PK of ABI-1179 following single dose administration in healthy participants. Part B (Phase 1b), in participants seropositive for HSV-2 with recurrent genital herpes, is evaluating weekly oral dosing regimens over a 29-day period in up to four cohorts randomized 20:5 between ABI-1179 and placebo with a pooled placebo analysis. Dosing is ongoing for cohort B3, evaluating a 10 mg weekly dosing regimen of ABI-1179. Part B also evaluates antiviral activity by measuring changes in viral parameters including shedding rate, quantification of HSV-2 DNA levels obtained from anogenital swab samples, and clinical parameters including genital lesion rate and duration. Due to the observed half-life of ABI-1179, the safety follow-up period for participants extends for 29 days after dosing (Day 57), with safety data available as of the data cutoff date through Day 57 for all participants from these cohorts that completed the evaluation period. The study uses pooled data from placebo recipients across cohorts as a control. As additional placebo recipients are enrolled in later cohorts, the sample size for the pooled placebos will change, which is expected to result in adjustments to both the observed effect sizes compared to placebo and the tests of statistical significance for those observed effects.

Additional information about the Phase 1a/b trial is available at clinicaltrials.gov using the identifier NCT06698575.

ABI-5366-101 Study Overview

ABI-5366-101 is a randomized, blinded, placebo-controlled Phase 1a/b clinical study. Positive interim data have been previously reported for Part A (Phase 1a), evaluating the safety, tolerability and PK of ABI-5366 following single dose administration in healthy participants. Positive interim data have also previously been reported for two weekly oral dosing regimens over a 29-day period in Part B (Phase 1b, cohorts B1 and B2), in participants seropositive for HSV-2 with recurrent genital herpes. Part B of the study enrolled three cohorts randomized 20:5 between ABI-5366 and placebo with a pooled placebo analysis. Safety follow up is ongoing for cohort B3. Part B also evaluates antiviral activity by measuring changes in viral parameters including shedding rate, quantification of HSV-2 DNA levels obtained from anogenital swab samples, and clinical parameters including genital lesion rate and duration. Due to the long half-life of ABI-5366, the safety follow-up period for participants extends for 98 days after dosing (Day 127), with all safety data available as of the data cutoff date for all participants in cohorts B1 and B2 and up to Day 43 for all participants from the B3 cohort that completed the evaluation period. Complete, unblinded safety data are included for cohorts B1 and B2, with blinded safety data for cohort B3. The study uses pooled data from placebo recipients across cohorts as a control. As additional data for placebo recipients from cohort B3 become available, it is expected to result in adjustments to both the observed effect sizes compared to placebo and the tests of statistical significance for those observed effects.

Additional information about the Phase 1a/b trial is available at clinicaltrials.gov using the identifier NCT06385327.

Webcast and Conference Call Information

Assembly Bio will be hosting a live webcast today at 6 p.m. ET. The live webcast can be accessed on the Investors section on the Company’s website at https://investor.assemblybio.com/events-presentations. A replay of the webcast will be available following the call.

About Recurrent Genital Herpes

Genital herpes is a chronic viral infection caused by HSV that can result in painful genital lesions, serious psychological and social impacts, and an increased risk of acquiring human immunodeficiency virus (HIV). Epidemiologic studies estimate over four million people in the United States, France, Germany, Italy, Spain and the United Kingdom experience recurrent genital herpes, with most people with initial symptomatic genital HSV-2 infection having three or more recurrences per year. While genital herpes can be caused by either HSV type 1 (HSV-1) or HSV-2, recurrences are more likely to be experienced by individuals infected by HSV-2. The current standard of care for recurrent genital herpes is nucleoside analogs given intermittently for recurrences or as daily chronic suppressive therapy; however, these are only partially effective in preventing recurrences and in reducing transmission of the virus. No new drugs have been approved in the United States or Europe to treat genital herpes for more than 25 years.

About Helicase-Primase Inhibition

HSV helicase-primase inhibitors target the viral helicase-primase complex, an essential viral enzyme complex that is conserved across both HSV-1 and HSV-2 and has no host equivalent. Inhibition of the helicase-primase complex is a clinically validated mechanism that has shown the potential for superior efficacy to the current standard of care, nucleoside analogs, in short-duration clinical studies in participants with recurrent genital herpes.

About Assembly Biosciences

Assembly Biosciences is a biotechnology company dedicated to the development of innovative small-molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com.

Forward-Looking Statements

The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead, including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data may not differentiate Assembly Bio’s product candidates from other companies’ candidates; Assembly Bio’s ability to maintain financial resources and secure additional funding necessary to continue its research activities, clinical studies, and other business operations; potential effects of changes in government regulation, including as a result of the change in U.S. administration in 2025; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Investors:
Meru Advisors
Patrick Till
(415) 788-8560
investor_relations@assemblybio.com

Media:
Sam Brown LLC
Alyssa Kuciunas
(331) 481-3751
ASMBMedia@sambrown.com

Dyne Therapeutics Announces Proposed Public Offering of Common Stock




Dyne Therapeutics Announces Proposed Public Offering of Common Stock

WALTHAM, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) — Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced that it has commenced an underwritten public offering of $300,000,000 of shares of its common stock. Dyne also intends to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 of shares of its common stock. All of the shares in the proposed offering are to be sold by Dyne.

Morgan Stanley, Jefferies, Stifel and Guggenheim Securities are acting as joint book-running managers for the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (“SEC”) on March 5, 2024 and became automatically effective upon filing. This offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering is expected to be filed with the SEC and, if and when filed, copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell, or a 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 registration or qualification under the securities laws of any such state or jurisdiction.

About Dyne Therapeutics

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

Forward-Looking Statements  

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements relating to the proposed underwritten public offering, the anticipated terms of the proposed offering, market and other conditions relating to the offering, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all and other factors discussed in the “Risk Factors” section of the preliminary prospectus supplement to be filed with the SEC, as well as the risks and uncertainties identified in Dyne’s filings with the SEC, including Dyne’s most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne’s views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne’s views as of any date subsequent to the date of this press release.

Contacts:

Investors

Mia Tobias
ir@dyne-tx.com
781-317-0353

Media

Stacy Nartker
snartker@dyne-tx.com
781-317-1938

Wave Life Sciences Announces Proposed $250 Million Public Offering of Ordinary Shares and Pre-Funded Warrants




Wave Life Sciences Announces Proposed $250 Million Public Offering of Ordinary Shares and Pre-Funded Warrants

CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) — Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health (“Wave” or “Wave Life Sciences”), announced today that it has commenced an underwritten public offering of $250 million in aggregate of its ordinary shares, and, to certain investors that so choose in lieu of ordinary shares, pre-funded warrants to purchase ordinary shares. In connection with the offering, Wave intends to grant the underwriters a 30-day option to purchase ordinary shares in an amount up to an additional 15% of the total amount of ordinary shares and shares underlying pre-funded warrants sold in the public offering on the same terms and conditions. All of the securities in the offering will be sold by Wave Life Sciences.

Jefferies, Leerink Partners and BofA Securities are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The offering will be made only by means of a prospectus and related prospectus supplement forming part of a shelf registration statement that was previously filed with the Securities and Exchange Commission (“SEC”) and became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov, copies of which may be obtained, when available, from Jefferies LLC, by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com; from Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; or from BofA Securities, NC1-022-02-25, 201 North Tyron Street, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by emailing dg.prospectus_requests@bofa.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Wave Life Sciences

Wave Life Sciences (Nasdaq: WVE) is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Wave’s RNA medicines platform, PRISM®, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and common disorders. Its toolkit of RNA-targeting modalities includes editing, splicing, RNA interference, and antisense silencing, providing Wave with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Wave’s diversified pipeline includes clinical programs in obesity, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy, and Huntington’s disease, as well as several preclinical programs utilizing the company’s broad RNA therapeutics toolkit. Driven by the calling to “Reimagine Possible,” Wave is leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Wave is headquartered in Cambridge, MA.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements regarding the proposed public offering of ordinary shares and pre-funded warrants to purchase ordinary shares, including Wave’s expectations regarding the size of the proposed public offering. These statements are subject to various risks and uncertainties, actual results could differ materially from those projected and Wave cautions investors not to place undue reliance on the forward-looking statements in this press release. These risks and uncertainties include, without limitation, risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the public offering. There can be no assurance that Wave will be able to complete the public offering on the anticipated terms, or at all. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, the risks and uncertainties described in the section entitled “Risk Factors” in Wave’s preliminary prospectus supplement related to the proposed offering to be filed with the SEC and Wave’s most recent Annual Report on Form 10-K filed with the SEC and in other filings Wave makes with the SEC from time to time. Wave undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

Contact:
Kate Rausch
VP, Corporate Affairs and Investor Relations
+1 617-949-4827

Investors:
James Salierno
Director, Investor Relations
+1 617-949-4043
InvestorRelations@wavelifesci.com

Media:
Katie Sullivan
Senior Director, Corporate Communications
+1 617-949-2936
MediaRelations@wavelifesci.com

Surgery Partners and Baylor Scott & White Health Form Joint Venture to Expand Access to Quality Care




Surgery Partners and Baylor Scott & White Health Form Joint Venture to Expand Access to Quality Care

The Physicians Centre Hospital in Bryan to become a Baylor Scott & White facility, as health system grows to keep up with population increase in the Brazos Valley

BRENTWOOD, Tenn., and BRYAN/COLLEGE STATION, Texas, Dec. 08, 2025 (GLOBE NEWSWIRE) — Surgery Partners, Inc. (NASDAQ:SGRY) announces a new partnership with Baylor Scott & White Health, the largest not-for-profit health system in Texas, to jointly own with physicians the 16-bed hospital in Bryan known as The Physicians Centre Hospital*. Patients will be able to continue care with their current provider at the location. The hospital will operate under the Baylor Scott & White name in the future, with Surgery Partners continuing to manage daily operations.

The hospital has been recognized for surgical excellence and patient satisfaction. It offers a broad range of surgical options for bariatric, ophthalmologic, oral/maxillofacial, orthopedic, gastroenterological, podiatric, spinal and urologic conditions. The team also provides general, plastic, and reconstructive surgery, as well as sports medicine, pain management and radiology services.

“This marks a significant step forward in expanding access to quality patient care in the Bryan College Station community,” said Mike Sanborn, chief growth officer, Baylor Scott & White. “This joint venture partnership reflects our ongoing dedication to customer-centered care and strategic growth in the communities we serve.”

This facility will complement the surgical care services offered throughout the Baylor Scott & White – College Station Region, for a full continuum of surgical care close to home.

“We are committed to offering our patients access to exceptional care close to where they live and work,” said Jason Jennings, president, Baylor Scott & White – College Station Region. “This partnership allows us to further enhance our services and deliver a seamless experience for our community as it continues to grow.”

“We are excited to add Baylor Scott & White to our partnership at The Physicians Centre Hospital,” said Jennifer Baldock, Executive Vice President, Chief Administrative & Development Officer. “The new joint venture integrates our patient-centric hospital with one of the nation’s most respected health systems and provides the opportunity to serve additional patients, attract new physician partners, and broaden our breadth and depth of services.”

About Surgery Partners

Headquartered in Brentwood, Tennessee, Surgery Partners is a leading healthcare services company with a differentiated outpatient delivery model focused on providing high quality, cost effective solutions for surgical and related ancillary care in support of both patients and physicians. Founded in 2004, Surgery Partners is one of the largest and fastest growing surgical services businesses in the country, with more than 200 locations in 30 states, including ambulatory surgery centers, surgical hospitals, multi-specialty physician practices and urgent care facilities. For additional information, visit www.surgerypartners.com.

About Baylor Scott & White Health

As the largest not-for-profit health system in the state of Texas, Baylor Scott & White is empowering customers to live well by reimagining traditional healthcare — creating more convenient, personalized and informed experiences. It serves more than three million customers through 53 hospitals, including flagship academic medical centers in Dallas, Fort Worth and Temple; the Baylor Scott & White Research Institute; 1,300+ access points; 59,000+ team members; and its leading digital platform — MyBSWHealth. The system’s award-winning employer solutions include Baylor Scott & White Health Plan, Baylor Scott & White Quality Alliance and Levanto — a company offering digitally enabled health products. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White’s mission is to promote the health and well-being of all individuals, families and communities.

For more information, visit: BSWHealth.com

*Joint Ownership with Physicians / Notice Regarding Physician Ownership: These are hospitals in which physicians have an ownership or investment interest. The list of physician owners or investors is available to you upon request. Physicians provide clinical services as members of the medical staff at one of Baylor Scott & White Health’s subsidiary, community or affiliated medical centers and are neither employees nor agents of those medical centers nor Baylor Scott & White Health.

Contacts:
Surgery Partners Investor Relations
(615) 234-8940
IR@surgerypartners.com

Baylor Scott & White Media Contact: Christy Millweard
(512) 366-7877
Christina.Millweard@BSWHealth.org

Nelipak® Acquires Merrill’s Packaging




Nelipak® Acquires Merrill’s Packaging

Strengthens presence in growing healthcare manufacturing and innovation hubs.

CRANSTON, R.I., Dec. 08, 2025 (GLOBE NEWSWIRE) — Nelipak^® Corporation (“Nelipak”), a leading global provider of healthcare packaging solutions, announced today that it has completed the acquisition of Merrill’s Packaging.

Merrill’s Packaging specializes in custom thermoformed packaging solutions for medical device, pharmaceutical, life science, and other demanding applications. Merrill’s also offers complementary products and services such as die-cut pouch/mounting cards and value-added design, development, and tooling services. Merrill’s operating footprint includes production sites in Burlingame, CA and Alajuela, Costa Rica which are ISO 13485 certified and equipped with ISO Class 8 cleanrooms.

Merrill’s Packaging was founded in 1961 and over more than six decades has grown to become a leader in custom thermoforming by focusing on the unique needs of its customers and consistently delivering quality, service, innovation, and professional attention. Merrill’s growth milestones include entering the Costa Rica market in 2010 and opening a new larger Costa Rica site in 2024.

“We are excited to welcome the Merrill’s Packaging team to the Nelipak family,” said Pat Chambliss, CEO Nelipak. “We have tremendous respect for their history of growth, innovation, and customer focus. Nelipak will benefit from Merrill’s dedicated and talented team, custom thermoforming capabilities, strong customer relationships, and well-located production sites in California and Costa Rica.”

“This is an incredible growth opportunity for Merrill’s employees and customers,” said Rick Schulz, Merrill’s CEO. “With access to Nelipak’s global capabilities and broad suite of rigid and flexible product solutions, we look forward to exploring new ways to deliver value to our customers.”

About Nelipak^®

Nelipak^® is a leading global provider of healthcare packaging solutions including rigid and flexible sterile-barrier packaging for medical device, diagnostic, pharmaceutical drug delivery, and other demanding applications. To support the development of innovative sustainable packaging solutions, Nelipak^® offers in-house design, prototyping, tooling, simulation, validation, laboratory, and other value-added services as well as a line of tray sealing equipment. With over 1,600 employees, Nelipak operates at 14 sites globally, including 8 sites in the Americas (USA, Costa Rica, Puerto Rico), 5 sites in Europe (Ireland, Netherlands, UK), and 1 site in Asia (Singapore). Nelipak^® is committed to delivering superior quality, service, and customer experience through world-class cleanroom manufacturing. For more information, visit www.nelipak.com.

Follow us on:

LinkedIn:
https://www.linkedin.com/company/nelipak

X:
https://x.com/nelipak1953

CONTACT: Nelipak® Marketing Contact:
Seán Egan
Director of Global Marketing
Nelipak®
+353-91-709-163
sean.egan@nelipak.com

Press Contact:
Jordan Bouclin
SVM Public Relations
401-490-9700
jordan.bouclin@svmpr.com

International study offers new path to reduce spinal taps in young infants with fevers




International study offers new path to reduce spinal taps in young infants with fevers

New evidence from a six-country study led by the Montreal Children’s Hospital and Children’s National Hospital shows simple blood and urine tests could spare many young infants with fevers from more invasive procedures.

Washington, DC, Dec. 08, 2025 (GLOBE NEWSWIRE) — A simple combination of blood and urine tests may allow many infants with fevers (febrile) to safely avoid lumbar punctures (spinal taps), according to new findings from a major international study published today in JAMA. The results show that these noninvasive tests can reliably identify infants with fevers 28 days and younger who are at very low risk for invasive bacterial infections.

“For more than 40 years, pediatric researchers have been trying to determine how to safely do less testing for febrile infants in the first month of life without missing uncommon, but dangerous infections,” said Brett Burstein, MDCM, PhD, MPH, lead author of the study and pediatric emergency physician at the Montreal Children’s Hospital.

Febrile infants younger than 28 days old are routinely evaluated for invasive bacterial infections such as bacterial meningitis because their early symptoms can be subtle. Most hospitals automatically perform a full infection workup, including spinal taps, then administer intravenous antibiotics, even when a febrile infant appears well.

“Fever in the first month of life is one of the highest stakes situations we face in pediatric care,” said Nathan Kuppermann, MD, MPH, senior author of the study, chief academic officer at Children’s National, a pediatric emergency physician and director of the Children’s National Research Institute. “Studying these uncommon infections really required international collaboration. Our findings show we can now use a validated, evidence-based rule to identify many of these young febrile infants who are extremely unlikely to have bacterial meningitis, which can support more personalized decisions for families.”

“Our analysis included more than 2,500 febrile infants across multiple countries and, using three widely available laboratory tests without spinal taps, performed with excellent diagnostic accuracy for ruling out invasive bacterial infections, Importantly, achieving zero missed cases of bacterial meningitis in such a large number of febrile infants in the first month of life is a critical benchmark in this area of research,” added Dr. Burstein, also a scientist in the Child Health and Human Development Program at the Research Institute of the McGill University Health Centre. “These results provide the level of evidence clinicians need to feel confident to strongly consider this approach.”

The study evaluated the performance of an updated febrile infant prediction rule from the Pediatric Emergency Care Applied Research Network (PECARN), a study for which Dr. Kuppermann served as principal investigator. The updated PECARN rule offers an evidence-based way to identify young febrile infants for whom a less invasive approach may be appropriate. The PECARN rule classifies a febrile infant as low risk if three criteria are met: The urinalysis is negative, the serum procalcitonin level is at or below 0.5 ng/mL and the absolute neutrophil count is at or below 4,000 per mm³. The rule does not require a spinal tap to determine risk and relies only on blood and urine tests routinely used in emergency departments worldwide.

Among the 2,531 infants from four international cohorts and the two US-based cohorts from which the PECARN rule was originally derived, the rule demonstrated a sensitivity of 94.8% and a negative predictive value of 99.6% for ruling out all invasive bacterial infections. Most importantly, none of the 22 cases of bacterial meningitis were missed among infants classified as low risk.

Families with questions about how fever is evaluated in young infants should speak with their physicians. Clinical decisions for infants 28 days and younger remain individualized and should be guided by pediatric experts.

Children’s National media contact: Media@childrensnational.org | (202) 476-4500
The Montreal Children’s Hospital media contact: christine.bouthillier@muhc.mcgill.ca | (514) 922-5696

###

About Children’s National Hospital
Children’s National Hospital, based in Washington, D.C., was established in 1870 to help every child grow up stronger. Today, it is one of the top 10 children’s hospitals in the nation and ranked in all specialties evaluated by U.S. News & World Report. Children’s National is transforming pediatric medicine for all children. The Children’s National Research & Innovation Campus opened in 2021, a first-of-its-kind pediatric hub dedicated to developing new and better ways to care for kids. Children’s National has been designated four times in a row as a Magnet^® hospital, demonstrating the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty care locations in the D.C. metropolitan area, including Maryland and Virginia. Children’s National is home to the Children’s National Research Institute and Sheikh Zayed Institute for Pediatric Surgical Innovation. It is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels. In 1987, Children’s National founded Safe Kids Worldwide, a non-profit dedicated to reducing unintentional injuries among children through comprehensive national and global education, research and advocacy. As a non-profit, Children’s National relies on generous donors to help ensure that every child receives the care they need.

For more information, follow us on Facebook, Instagram and LinkedIn.

About the Montreal Children’s Hospital

Established in 1904, the Montreal Children’s Hospital is Quebec’s oldest children’s hospital and the pediatric hospital of the McGill University Health Centre (MUHC). A tertiary and quaternary care teaching and research facility, treating newborns, children and adolescents up to age 18, it serves 63 per cent of the geographic population of Quebec.

With its pediatric care and research facilities adjacent to the adult facility on the Glen site, the Children’s is in a unique position to offer services and research across the lifespan. The Centre for Innovative Medicine – one of the Research Institute of the McGill University Health Centre’s research facilities and the only clinical research centre in a hospital setting in North America – allows its researchers to conduct clinical trials on the hospital site. 

The Montreal Children’s Hospital is a leader in providing a broad spectrum of highly specialized care to young patients and families from all across Quebec. The hospital is a provincially designated trauma centre and is recognized for its wealth of expertise in cardiology and cardiac surgery, emergency care, neurology and neurosurgery. montrealchildrenshospital.ca

CONTACT: Media
Children's National Hospital
2024764500
Media@childrensnational.org

Cullinan Therapeutics Showcases Compelling Clinical Data in AML for CLN-049, Novel FLT3xCD3 T Cell Engager, in Oral Presentation at the 67th ASH Meeting




Cullinan Therapeutics Showcases Compelling Clinical Data in AML for CLN-049, Novel FLT3xCD3 T Cell Engager, in Oral Presentation at the 67th ASH Meeting

CLN-049 monotherapy demonstrates promising efficacy, including multiple complete responses and encouraging response durability, in a heavily pretreated all-comer population of patients with R/R AML

31% CR/CRh rate observed at the highest target dose tested to date; initial dose escalation results in 45 patients demonstrate a favorable safety profile across all doses assessed

CLN-049 recently granted Fast Track designation by the U.S. FDA

Company to host in-person event on Monday, December 8, at 8:00 p.m. ET

CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) — Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today shared updated clinical data from its Phase 1 study of CLN-049, a novel, investigational FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). These data will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9, as an oral presentation on Monday, December 8, at 10:45 a.m. ET.

“These promising clinical data, including multiple complete responses and encouraging initial data for response durability, demonstrate the potential for CLN-049 to expand treatment options for a broad population of people with AML, including patients with TP53-mutated AML who currently face a particularly poor prognosis,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “Coupled with recent Fast Track designation from the FDA, which underscores the promise of CLN-049 to help patients with AML, Cullinan is committed to rapidly advancing this potential new treatment option for a devastating disease.”

“Despite advances in select settings, AML remains an aggressive blood cancer with limited options for durable response, particularly for patients with relapsed or refractory disease,” said Mohammad Maher Abdul Hay, MD, Director, Clinical Leukemia Program, Perlmutter Cancer Center, and Director, Blood & Marrow Transplantation and Cellular Therapy Program, NYU Langone Health. “CLN-049 represents a novel approach to target AML as it binds to the extracellular domain of FLT3, both wildtype and mutated forms, redirecting a patient’s own T cells to recognize and eliminate leukemic cells. FLT3 is a particularly promising target for this therapeutic approach since it is expressed by AML blasts in more than 80% of patients. The compelling early efficacy including durability data shared today show the potential impact a FLT3-targeted T cell engager could have for AML patients in need of new options.”

Efficacy Results

As of the August 2025 data cutoff, 45 patients (39 AML, 3 MDS/AML, and 3 MDS) were enrolled without regard to FLT3 cell surface expression across 8 cohorts (target dose range 1.5-12 µg/kg). 41 patients across 7 cohorts were efficacy evaluable, having reached at least one on-treatment response assessment. Patients with AML had received a median of 2 prior therapies (range: 1-8).

For AML, response was assessed using ELN 2022 criteria. Efficacy endpoints include complete response (CR) rate, composite complete response (CRc) rate (CR/complete remission with incomplete recovery (CRi)/complete remission with partial hematologic recovery (CRh)).

Promising monotherapy activity was observed in heavily pretreated patients with AML at clinically active target doses:

• At the highest target dose studied thus far of 12 µg/kg (n=16), CR/CRh rate was 31% (5/16) and CRc rate was 31% (5/16).
• Anti-leukemic activity was observed at target doses ≥6 µg/kg (n=32), with a CR/CRh rate of 25% (8/32) and a CRc rate of 28% (9/32).

Data show promising initial durability in responders, including measurable residual disease (MRD) negativity:

• At efficacious doses (≥6 µg/kg), in the patients achieving a CR/CRh response, 63% (5/8) of patients had a duration of response of >16 weeks and 2 additional patients were able to proceed to allogeneic hematopoietic stem cell transplant.
• In 10/32 patients achieving bone marrow blasts <5% at a target dose of ≥6 µg/kg, 30% (n=3) patients were MRD negative by flow cytometry, and 1 MRD-negative patient has had an ongoing response for >36 weeks.

Encouraging responses were observed in difficult-to-treat AML patients with high-risk genetic features:

• Notably, among the 8 patients with TP53-mutated AML treated at 12 µg/kg, 50% (4/8) of patients achieved a CR/CRh response: 3 patients achieved a CRh response and 1 patient achieved a CR; 3/4 patients with CR/CRh had responses that were durable >16 weeks.
• Responses were observed in patients with AML independent of baseline FLT3 expression and regardless of baseline genetic risk.

Safety Results

As of the August 2025 data cutoff, the data demonstrate a favorable safety profile in a broad population of patients with R/R AML and MDS (N=45):

• The most common treatment-emergent adverse events (TEAEs) included cytokine release syndrome (CRS) (35.6%), infusion-related reaction (33.3%), febrile neutropenia (20.0%), white blood cell count decrease and pneumonia (17.8% each), diarrhea, hypomagnesemia, stomatitis, and hypokalemia (15.6% each).
• Nearly all CRS events limited to Grade 1 or 2, and the majority occurred after a step-up dose (SUD) or target dose 1. No Grade 3 CRS was observed with two step-up doses. CRS did not lead to treatment discontinuation.
• Grade ≥3 TEAEs occurring in >10% of patients included febrile neutropenia (20.0%), white blood cell count decrease (17.8%), pneumonia and neutrophil count decrease (11.1% each).

CLN-049 development will proceed under FDA Fast Track designation. Dose escalation continues in this ongoing Phase 1 study, with expansion cohorts planned in early 2026.

Live and Virtual Investor Event

Cullinan Therapeutics will host an in-person event for analysts and institutional investors on Monday, December 8, at 8:00 p.m. ET, during which David Sallman, MD, Associate Member, Myeloid Section Head, Moffitt Cancer Center & Research Institute, will participate in a discussion of the CLN-049 data shared at the 2025 ASH Annual Meeting and Exposition with members of Cullinan Therapeutics management. Participants from Cullinan Therapeutics include Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, MD, MBA, Chief Medical Officer.

Investors and analysts are invited to register to attend in person by emailing Nick Smith, Head of Investor Relations (nsmith@cullinantx.com). A webcast will be available via the events page of the Company’s investor relations website at https://investors.cullinantherapeutics.com/events.

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 bispecific T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, allowing targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00).

CLN-049 has received Fast Track designation from the U.S. FDA for the treatment of relapsed/refractory AML.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common form of acute leukemia in adults.^1,2 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.³ Each year in the U.S., approximately 22,000 people are diagnosed with AML, and about half as many lives are lost to the disease.⁴ Globally, AML affects an estimated 144,000 people annually, with approximately 130,000 deaths.⁵

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.^4,6 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.^7,8 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.⁸ Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

About Cullinan Therapeutics

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow Cullinan on LinkedIn and X.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our clinical developments plans and timelines for CLN-049, the clinical and therapeutic potential of CLN-049, our plans regarding future data presentations, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any NDAs, INDs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not approved or cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

Contacts:

Investors
Nick Smith
+1 401.241.3516
Nsmith@cullinantx.com

Media
Rose Weldon
+1 215.801.7644
Rweldon@cullinantx.com

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1. American Association for Cancer Research. (2025). Acute Myeloid Leukemia. https://www.aacr.org/patients-caregivers/cancer/acute-myeloid-leukemia/
2. National Cancer Institute. (2025). Acute Myeloid Leukemia Treatment (PDQ^®)–Patient Version. https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq
3. Leptidis J., et al. (2014). Fatal cardiac tamponade as the first manifestation of acute myeloid leukemia. Am J Emerg Med 32(10). https://doi.org/10.1016/j.ajem.2014.02.045
4. National Cancer Institute. (2025). Cancer Stat Facts: Leukemia — Acute Myeloid Leukemia (AML). https://seer.cancer.gov/statfacts/html/amyl.html
5. Zhou, Y., et al. (2024). Global, regional, and national burden of acute myeloid leukemia, 1990–2021: A systematic analysis for the Global Burden of Disease Study 2021. Biomarker Research, 12(101). https://doi.org/10.1186/s40364-024-00649-y
6. Moore, CG., et al. (2025). Treatment of Relapsed/Refractory AML—Novel Treatment Options Including Immunotherapy. Am J Hematol. (100)2. https://doi.org/10.1002/ajh.27584
7. Shahzad, M., et al. (2024) What have we learned about TP53-mutated acute myeloid leukemia?. Blood Cancer J. 14(202). https://doi.org/10.1038/s41408-024-01186-5
8. Kantarjian H., et al. (2021). Acute myeloid leukemia: current progress and future directions. Blood Cancer J. 11(2). https://doi.org/10.1038/s41408-021-00425-3

Corvus Pharmaceuticals Presents Final Data from Soquelitinib Phase 1/1b T Cell Lymphoma Trial




Corvus Pharmaceuticals Presents Final Data from Soquelitinib Phase 1/1b T Cell Lymphoma Trial

Patients in 200 mg BID cohort had median progression free survival of 6.2 months and median overall survival of 28.1 months, comparing favorably to results with other therapies

Data supports ongoing registration Phase 3 trial in r/r PTCL, Phase 1 trial in atopic dermatitis and potential expansion into other immune and inflammatory diseases

Highlights ITK inhibition novel mechanism of action affecting T cell receptor signaling and T cell differentiation

Presented in an oral session at the 67th American Society of Hematology Annual Meeting & Exposition

SOUTH SAN FRANCISCO, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) — Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, announced the presentation of final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma today in an oral session at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, which is taking place December 6-9, 2025 in Orlando, FL. The presentation highlights preclinical and clinical data supporting the development of soquelitinib in oncology and immune and inflammatory diseases, including data detailing its mechanism of action.

“The T-cell lymphomas are devastating diseases, associated with dismal outcomes, and are thus an area of high unmet need,” said Ryan Wilcox, M.D., Ph.D., Associate Professor of Internal Medicine, University of Michigan Medical School. “In the relapsed/refractory setting, complete and durable responses are rarely achieved with currently available agents. The Phase 1 data demonstrate impressive progression free and overall survival in relapsed/refractory patients treated with soquelitinib. Several patients experienced complete and durable responses, some of which were maintained on therapy more than two years. For most relapsed/refractory PTCL patients, an overall survival less than 6 months is anticipated. In the phase 1 study, median progression free survival was 6.2 months and median overall survival exceeded 2 years. These results provide the foundation for the ongoing registration Phase 3 trial in relapsed/refractory peripheral T cell lymphoma.”

The trial enrolled 75 patients (27 in dose escalation portion and 48 in dose expansion portion) with various T cell lymphomas, including peripheral T cell lymphoma (PTCL), T follicular helper cell lymphoma (TFHC), natural killer cell T cell lymphoma (NKTCL), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and adult T cell lymphoma/leukemia (ATLL). The median number of prior therapies was 3 (range 1-18), with only 31% achieving an objective response to their most recent prior therapy. In the dose escalation portion, patients received a twice-daily dose of soquelitinib of 100 mg, 200 mg, 400 mg or 600 mg, and the 200 mg twice-daily dose was selected for the dose expansion portion based on biomarker studies indicating that doses of 200mg or higher achieved complete occupancy of the ITK target with the drug.

Key highlights from the data supporting the ongoing registration Phase 3 trial in relapsed/refractory PTCL include:

• No dose limiting toxicities or significant adverse events were observed in any patients in all dose cohorts up to 600 mg twice-daily, including no myelosuppression or immunosuppression
• Objective and durable tumor responses were seen in the 200 mg twice-daily cohort (N=36) with 6 patients experiencing complete responses 
• In the 200 mg twice-daily cohort, it was determined that patients with between ≥1 and ≤3 prior therapies and an adequate peripheral blood lymphocyte count (N=24) were most likely to be responders to therapy. In this patient population:
  • Objective responses were seen in 9 of 24 patients including 6 complete responses and 3 partial responses
  • Median progression free survival (PFS) was 6.2 months, including an 18-month PFS of 30%
  • Median overall survival (OS) was 28.1 months, including a 24-month OS of 67%

Key highlights from the data supporting soquelitinib’s mechanism of action (Th1 skewing and blocking Th2 and Th17 differentiation) and use in immune and inflammatory diseases include:

• In vitro studies demonstrated that at appropriate doses, soquelitinib produces Th1 skewing, which is an immunologic property resulting from the blockade of Th2 differentiation and a shift to Th1
• Biomarker studies evaluating blood samples and tumor biopsies showed an increase in Th1 in blood and tumor samples and a reduction in serum IL-5, consistent with inhibiting Th2 and Th17 cells
• For 6 patients, paired tumor biopsies were compared at baseline and day 8 and showed an increase in intratumor Th1 cells with treatment analyzed using RNA sequencing

“The data presented at ASH provides foundational information for the future development of soquelitinib and our ITK platform across oncology, immune disease and inflammation,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “In oncology, the data show that soquelitinib could be a new treatment option for T cell lymphomas, including in patients with advanced, aggressive disease. The data not only support our ongoing registration Phase 3 trial in PTCL, but also show immunobiological effects that demonstrate soquelitinib’s mechanism of action of affecting T cell differentiation via ITK inhibition.  The mechanism operates upstream in T cell signaling pathways, which may indicate that resistance pathways are unlikely to evolve.”

Dr. Miller added, “Outside of oncology, we are focused on the development of soquelitinib in atopic dermatitis and evaluating its potential in a broad range of immune and inflammatory diseases. We plan to present additional data from extension cohort 4 of our Phase 1 atopic dermatitis trial in January and initiate a Phase 2 trial in this indication in early Q1 2026.”

Corvus is currently enrolling patients in a registration Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy. The Company anticipates reporting interim data from the Phase 3 trial in late 2026 and completing the trial in 2027. 

The ASH oral presentation slides are available on the Publications and Presentations page of the Corvus website.

About Corvus Pharmaceuticals 
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Soquelitinib is now in a registration Phase 3 clinical trial for relapsed/refractory PTCL and in a Phase 1 clinical trial for the treatment of atopic dermatitis. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com or follow the Company on LinkedIn.

About Soquelitinib
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation, which has the potential to suppress autoimmune and inflammatory reactions. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company has initiated a registration Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed/refractory PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled phase 1 clinical trial in patients with atopic dermatitis. A recent publication describing the chemistry, enzymology and biology of soquelitinib appeared in npj Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website.

About Peripheral T Cell Lymphoma
Peripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. First line treatment for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed/refractory PTCL based on randomized trials.

PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations in the T cell receptor signaling pathway. These mutations can result in tonic signaling and play a role in lymphomagenesis. ITK plays a crucial role in T cell receptor signaling, and treatment with an ITK inhibitor can block the signaling pathway. Most often the malignant cells of PTCL express a Th2 phenotype.

About Atopic Dermatitis
Atopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to data supporting the Company’s ongoing clinical trial, development of soquelitinib in oncology and immune and inflammatory diseases, soquelitinib’s mechanism of action and soquelitinib as a new treatment option for T cell lymphomas, including in patients with advanced, aggressive disease; the potential safety and efficacy of the Company’s product candidates; clinical strategy and the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, dose levels, number of sites and other product development milestones; and the availability and timing of clinical and preclinical data announcements and clinical readouts, including data from extension cohort 4 of the Phase 1 clinical trial for atopic dermatitis with soquelitinib. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the third quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 4, 2025, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the cash on hand providing funding into the fourth quarter of 2026 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com