AbCellera (ABCL) Phase 2 data show strong ABCL635 benefit in menopausal hot flashes
Rhea-AI Filing Summary
AbCellera Biologics Inc. reported positive Phase 2 results for ABCL635, an investigational neurokinin 3 receptor (NK3R) antagonist antibody being developed as a non-hormonal, long-acting subcutaneous treatment for moderate-to-severe vasomotor symptoms (VMS) due to menopause. In a randomized, double-blind, placebo-controlled trial of 92 postmenopausal women (46 ABCL635, 46 placebo), a single 600 mg dose met the primary efficacy endpoints at week 4.
ABCL635 reduced VMS frequency by a mean of 8.8 moderate/severe hot flashes per day from baseline versus 3.5 for placebo, a placebo-adjusted difference of 5.3 and an 83% vs 33% mean percent reduction. Severity improved with a mean reduction of 1.4 points vs 0.3 for placebo, and mean percent reduction of 58% vs 12%. At week 4, 84% of ABCL635 patients rated symptoms as “Much Better” or “Moderately Better” versus 27% on placebo, and sleep disturbance scores improved with a placebo-adjusted change of -5.5 points. ABCL635 was described as well tolerated, with no serious or severe adverse events in the active arm, no meaningful liver or gastrointestinal safety signal, and headache, fatigue, and injection-site reactions as the most common events. The company plans 12-week follow-up, additional data presentations, and regulatory interactions to discuss late-stage development.
Positive
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Filing Explained
ABCL635 remains an investigational Phase 2 program; the new presentation limits “best-in-class” comparisons because no head-to-head trial was conducted.
The company furnished an Item 7.01 Form 8-K reporting four-week top-line Phase 2 results for ABCL635. The drug remains investigational, and the presentation identifies 12-week follow-up as a next step, so the disclosure does not represent regulatory approval or a completed development program.
The accompanying presentation describes a randomized trial of 92 postmenopausal women, split evenly between a single 600 mg ABCL635 dose and placebo, with an optional open-label extension.
Although the company describes the results as having “best-in-class” potential, the presentation states that no head-to-head clinical trial was conducted, limiting direct comparison with approved small-molecule treatments.
At the July 30 data cutoff, the detailed safety table records one mild ABCL635-related increase in transaminases, with AST of 92 and ALT of 66 IU/L, which resolved in one week; the filing reports no serious or grade 3+ adverse events in that group.
8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Participants enrolled: 92 postmenopausal women
Reduction in VMS frequency: 8.8 vs 3.5 events/day
Percent reduction in VMS frequency: 83% vs 33%
+5 more
8 metrics
Participants enrolled
92 postmenopausal women
Phase 2 portion of the ABCL635 Phase 1/2 trial, randomized 1:1 to drug or placebo
Reduction in VMS frequency
8.8 vs 3.5 events/day
Mean change from baseline at week 4 for ABCL635 vs placebo, moderate/severe VMS
Percent reduction in VMS frequency
83% vs 33%
Mean percent reduction at week 4 for ABCL635 vs placebo, frequency endpoint
Reduction in VMS severity score
1.4 vs 0.3 points
Mean change from baseline at week 4 for ABCL635 vs placebo, severity endpoint
Patients reporting symptom improvement
84% vs 27%
Week 4 PGI-C ratings of “Much Better” or “Moderately Better” for ABCL635 vs placebo
Sleep disturbance treatment difference
-5.5 points
Placebo-adjusted change at week 4 on PROMIS-SD-SF-8b total T-score
Women with moderate-to-severe VMS in US
12M+
Company estimate of U.S. women experiencing moderate-to-severe vasomotor symptoms
Estimated non-hormonal VMS TAM
$6B+
Total addressable market estimate assuming small-molecule net-price parity
Key Terms
vasomotor symptoms, neurokinin 3 receptor (NK3R), Mixed Models for Repeated Measures, Patient Global Impression of Change, +2 more
6 terms
vasomotor symptoms medical
"treatment for moderate-to-severe vasomotor symptoms (VMSM-S), commonly known as hot flashes"
Vasomotor symptoms are sudden feelings of intense heat, often with sweating and rapid heartbeat, commonly known as hot flashes and night sweats; they occur when the body’s mechanism for controlling blood vessel widening and narrowing becomes unstable. Investors should care because these symptoms affect large patient groups and drive demand for treatments, influence clinical trial design and regulatory decisions, and can materially affect sales and market value of therapies addressing quality-of-life conditions—think of them as a thermostat malfunction that creates a clear medical market need.
neurokinin 3 receptor (NK3R) medical
"evaluating ABCL635, an investigational neurokinin 3 receptor (NK3R) antagonist antibody"
Mixed Models for Repeated Measures technical
"MMRM: Mixed Models for Repeated Measures; LSM (SE): Least Squares Mean"
A statistical method used to analyze data where the same people are measured repeatedly over time, such as serial lab tests or symptom scores in a clinical trial. It separates consistent differences between people from real changes over time and handles gaps when some measurements are missing, like comparing classmates’ test scores across semesters even if a few tests are missed. Investors care because this approach affects how convincingly a trial shows a treatment works or is safe, which influences regulatory decisions and company valuation.
Patient Global Impression of Change medical
"ABCL635 was also observed to significantly improve sleep and patient global impression of change"
A patient global impression of change is a simple, patient-reported rating that asks whether a person’s overall health or symptoms have gotten better, worse, or stayed the same after treatment. For investors, it matters because this kind of direct feedback can influence regulators’ and doctors’ views of a therapy’s real-world benefit and therefore affect approval prospects, prescribing behavior and market acceptance — think of it as customer satisfaction for a medical treatment.
PROMIS-SD-SF-8b medical
"PROMIS-SD-SF-8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance"
total addressable market financial
"Total Addressable Market estimated for non-hormonal treatments assuming only small-molecule"
Total addressable market is the total potential sales opportunity for a product or service if it were to reach every possible customer. It helps investors understand the maximum size of the market and the growth potential for a business. Think of it as the entire pie available to be shared, indicating how big the opportunity could be.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did AbCellera (ABCL) announce about its ABCL635 Phase 2 trial?
AbCellera announced positive top-line Phase 2 results for ABCL635, showing statistically significant reductions in frequency and severity of menopausal vasomotor symptoms versus placebo after a single 600 mg subcutaneous dose over four weeks.
How effective was ABCL635 in reducing hot flashes in the AbCellera (ABCL) study?
ABCL635 produced an 8.8 mean daily reduction in moderate/severe hot flashes at week 4 versus 3.5 for placebo, an 83% vs 33% mean percent reduction, yielding a placebo-adjusted difference of 5.3 events and 50% in relative terms.
What improvements in symptom severity were seen with ABCL635 in AbCellera’s (ABCL) trial?
ABCL635 reduced vasomotor symptom severity by a mean of 1.4 points at week 4 compared to 0.3 with placebo. Mean percent reduction in severity was 58% for ABCL635 versus 12% for placebo, with a placebo-adjusted difference of 46%.
Did ABCL635 improve sleep in AbCellera’s (ABCL) Phase 2 study?
Yes. ABCL635 significantly improved sleep disturbance scores, with a placebo-adjusted change of -5.5 points on the PROMIS-SD-SF-8b scale at week 4, with improvements across all 8 measured aspects of sleep, including quality, restfulness, and difficulty falling or staying asleep.
What were the safety results for ABCL635 in AbCellera’s (ABCL) Phase 2 trial?
ABCL635 was described as well tolerated with no serious or Grade 3+ adverse events in the active arm over four weeks. Common events were headache, fatigue, and injection-site reactions, and there was no liver or gastrointestinal safety signal observed to date.
How large is the potential market for ABCL635 according to AbCellera (ABCL)?
AbCellera estimates more than 12 million U.S. women experience moderate-to-severe vasomotor symptoms, over 6 million seek treatment, and about 20% are unsuitable for hormone therapy. It cites a non-hormonal treatment total addressable market of $6B+ annually under certain pricing assumptions.
What are AbCellera’s (ABCL) next steps for ABCL635 after this Phase 2 readout?
Planned next steps include completing 12-week follow-up to support dose selection, presenting additional data at major medical conferences, and holding regulatory interactions to discuss late-stage development in vasomotor symptoms due to menopause and oncology treatments.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
__________________________________________
FORM 8-K
__________________________________________
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): August 10, 2026
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Item 7.01 Regulation FD
On August 10, 2026, AbCellera Biologics Inc. (the “Company”) issued a press release announcing positive top-line results from the Phase 2 portion of its Phase 1/2 clinical trial evaluating ABCL635, an investigational neurokinin 3 receptor (NK3R) antagonist antibody, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K. In connection with announcing the top-line results from the Phase 2 portion of its Phase 1/2 clinical trial evaluating ABCL635, the Company will hold an investor conference call and webcast at 4:30 a.m. Pacific Time (7:30 a.m. Eastern Time) today. The webcast and accompanying investor presentation will be accessible on the “Investors” section of the company website at www.abcellera.com. A copy of the investor presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in Item 7.01 of this Form 8-K (including the exhibits attached hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing.
Item 9.01 Financial Statements and Exhibits
(d)Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | Press Release issued by AbCellera Biologics Inc. on August 10, 2026. | |||||||
| 99.2 | AbCellera Biologics Inc. Investor Presentation, dated August 10, 2026. | |||||||
| 104 | Cover Page Interactive Data File (embedded as Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 10, 2026 | ABCELLERA BIOLOGICS INC. | |||||||
| By: | /s/ Carl L. G. Hansen | |||||||
| Carl L. G. Hansen, Ph.D. | ||||||||
Chief Executive Officer and Director (Principal Executive Officer) | ||||||||
AbCellera Announces Positive Top-Line Phase 2 Clinical Trial Results for ABCL635, Demonstrating Significant Reduction in Frequency and Severity of Vasomotor Symptoms and a Favorable Tolerability Profile ● Phase 2 results showed best-in-class reductions in both frequency and severity of moderate-to-severe vasomotor symptoms after a single dose ● ABCL635 significantly improved sleep and patient global impression of change ● ABCL635 demonstrated a favorable tolerability profile ● AbCellera to host a conference call and live webcast today at 4:30 a.m. PT / 7:30 a.m. ET VANCOUVER, British Columbia– AbCellera (Nasdaq: ABCL) today announced positive top-line results from the Phase 2 portion of its Phase 1/2 clinical trial evaluating ABCL635, an investigational neurokinin 3 receptor (NK3R) antagonist antibody. ABCL635 is being developed as a non-hormonal, long-acting, subcutaneous treatment for moderate-to-severe vasomotor symptoms (VMSM-S), commonly known as hot flashes, due to menopause. The study met the primary efficacy endpoints achieving statistically significant reductions in both frequency and severity of VMSM-S at week 4 compared to placebo after a single dose. ABCL635 was also observed to significantly improve sleep and patient global impression of change (PGI-C). “The four-week data for the Phase 2 study of ABCL635 demonstrate a new efficacy benchmark for the reduction of hot flashes both in frequency and severity, as well as improvements in sleep. These symptoms can profoundly impact women's daily lives when left unmanaged,” said Dr. JoAnn V. Pinkerton, M.D., Women’s Midlife Professor of Obstetrics and Gynecology at the University of Virginia School of Medicine. “If validated in Phase 3, ABCL635 could offer a new treatment option with a more convenient dosing regimen and potentially less toxicity.” The randomized, double-blind, placebo-controlled, multicenter Phase 2 portion of the ABCL635 study enrolled 92 postmenopausal women experiencing a mean of approximately 10 moderate or severe hot flashes per day. The participants were randomized 1:1 to receive either a single subcutaneous 600 mg dose of ABCL635 or placebo. ABCL635 reduced VMSM-S frequency compared to placebo, with an 8.8 mean reduction in the number of moderate and severe events per day from baseline at week 4 (Day 29) compared to 3.5, showing a mean placebo-adjusted treatment difference of 5.3 (p<0.001). The mean percent reduction at week 4 for VMSM-S frequency was 83% for the ABCL635 treatment group versus a 33% reduction for placebo, leading to a mean placebo-adjusted treatment difference of 50%. ABCL635 also resulted in improvement in VMSM-S severity compared to placebo, with a mean reduction of 1.4 points at week 4 compared to 0.3, and a mean placebo-adjusted treatment difference of 1.1 (p<0.001). The mean percent reduction in VMSM-S severity from baseline to week 4 was 58% in the ABCL635 group compared to 12% in the placebo group, leading to a mean placebo-adjusted treatment difference of 46%.
Figure 1. Mean change from baseline in daily average frequency and severity of moderate-to-severe vasomotor symptoms (VMSM-S ) over four weeks. Least squares mean (LSM) change (±SE) in VMSM-S daily average frequency (left) and severity score (right) for participants treated with subcutaneous ABCL635 600 mg (N=46, light blue) compared to placebo (N=46, dark grey) through week 4. Statistical significance was maintained from week 1 through week 4 (p < 0.001). Meaningful improvements were also observed in patient sleep scores and patient global impression of change. ABCL635 was well-tolerated throughout the four-week treatment period with no serious adverse events, severe adverse events, or adverse events that led to study discontinuation. The most common adverse events in the ABCL635 treatment group and higher than placebo were headache, fatigue, and injection site reaction. “These positive results represent a significant milestone for women’s health and for AbCellera,” said Sarah Noonberg, M.D., Ph.D., Chief Medical Officer of AbCellera. “By successfully targeting the NK3 receptor with an antibody, we have demonstrated potential best-in-class vasomotor symptom relief over four weeks with a single subcutaneous dose. These data indicate that ABCL635 could offer menopausal women a well-tolerated, long-acting treatment that has the potential to markedly improve their quality of life.” AbCellera will hold an investor conference call at 4:30 a.m. Pacific Time (7:30 a.m. Eastern Time) today, August 10, 2026. A live audio webcast of the investor conference may be accessed through a link that will be posted on AbCellera’s Investor Relations website. A replay will be available through the same link following the conference call. About ABCL635
ABCL635 is a potential best-in-class investigational antibody drug for the non-hormonal, long-acting treatment of moderate-to-severe VMS, commonly known as hot flashes, due to menopause. ABCL635 specifically targets NK3R, a clinically validated G protein-coupled receptor (GPCR) expressed on KNDy neurons in the infundibular nucleus of the hypothalamus. ABCL635 is AbCellera’s first pipeline program from the GPCR and ion channel platform to advance into the clinic, in July 2025. Additional details are available at www.abcellera.com/pipeline. The Phase 2 trial of ABCL635 (NCT07118891) is a multicenter, randomized, double-blind, placebo-controlled trial in postmenopausal women with moderate-to-severe VMS due to menopause evaluating safety and efficacy of ABCL635. About VMS Hot flashes and night sweats, known as VMS, are the most common menopausal symptoms, impacting up to 80% of women. The majority rate their VMS as moderate to severe, characterized by intense feelings of heat that lead to sweating, chills, and interrupted sleep. VMS are the most frequent reason for seeking medical care for menopause. VMS can persist for many years after the final menstrual period, and the impact is felt across many aspects of everyday life, including sleep, concentration, energy and mood, work, social activities, and relationships. It is estimated that more than 12 million women in the US experience moderate-to-severe VMS, of which more than six million seek treatment. About AbCellera Biologics Inc. AbCellera (Nasdaq: ABCL) is a clinical-stage biotechnology company focused on discovering and developing first-in-class antibody-based medicines in the areas of endocrinology, women’s health, immunology, oncology, and more. For more information, please visit www.abcellera.com. AbCellera Forward-looking Statements This document contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this document other than statements of historical fact are forward-looking statements, including statements regarding the safety and efficacy profile and therapeutic potential of, and our ability to develop, commercialize and achieve market acceptance of, ABCL635. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Significant risks for ABCL635 include that (i) ABCL635 is an investigational agent subject to potential negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (ii) adverse results can unexpectedly occur at any stage prior to regulatory approval; (iii) data reported from ongoing clinical trials are necessarily interim data only and the
final results will change; and (iv) the timing of clinical trials and availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, or other reasons. These risks, uncertainties, other factors, and definition of our business metrics are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this document represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. Inquiries Media: Tiffany Chiu; media@abcellera.com, +1(236)521-6774 Partnering: Murray McCutcheon, Ph.D.; partnering@abcellera.com, +1(604)559-9005 Investor Relations: Peter Ahn; ir@abcellera.com, +1(778)729-9116 Source: AbCellera Biologics Inc.
CO PY RI GH T © A BC EL LE RA AUGUST 10, 2026 ABCL635 PHASE 2 CLINICAL UPDATE
These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties, other factors, and definition of our business metrics are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in our Annual Report on Form 10-K filed with the SEC on February 2, 2026 and the other documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this document represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. DISCLAIMER This document contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this document other than statements of historical fact are forward-looking statements, including statements regarding the safety and efficacy profile and therapeutic potential of, and our ability to develop, commercialize and achieve market acceptance of, ABCL635, and the expected addressable market related thereto. The use of certain data derived from cross-study comparisons is not based on any head-to-head clinical trials. Cross-study comparisons are inherently limited and may suggest misleading similarities and differences and are presented for informational purposes. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. 2 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6
3 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 SPEAKERS Carl Hansen, PhD Chief Executive Officer Sarah Noonberg, MD, PhD Chief Medical Officer CO PY RI GH T © A BC EL LE RA Kelsey Mills, MD Clinical Associate Professor of Obstetrics & Gynecology, University of British Columbia
4 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 Phase 2 data at week 4 suggest ABCL635 has the potential to be a best-in-class non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) Dosing convenience with long-acting subcutaneous self-injection Data supports an improved safety profile with reduced liver and gastrointestinal findings Markedly improved efficacy data compared to available non-hormonal therapies DISCLAIMER: Information provided above is for illustrative purposes only and no head-to-head clinical trials have been conducted. Differences exist between study or trial designs and subject characteristics, and caution should be exercised when comparing data across trials.
5 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 has the potential to address a large unmet need in VMS due to menopause and cancer treatment VMS Due to Menopause 1M+ women could benefit from safe and effective non-hormonal treatments.1 ~12M women in the US experience moderate-to-severe VMS.1 >6M of which seek treatment.1 20% for whom hormone therapy is unsuitable due to contraindications or other factors.2 1. Management estimate based on US census data, 2023; Todorova et al., Menopause, 2023; Nappi et al., Menopause, 2021; Stute et al., Maturitas, 2022. 2. Management estimate based on Nappi et al., Menopause, 2021; Stute et al., Maturitas, 2022. 3. Management estimate based on Wholesale Acquisition Cost of Veozah and Lynkuet (accessed from Micromedex Red Book) and above sources. Actual market size may differ. $6B+ Total Addressable Market estimated for non-hormonal treatments assuming only small-molecule net-price parity of ~$5K per patient per year.3 ● Breast cancer ● Prostate cancer ● Ovarian cancer VMS Due to Cancer Treatment Many patients experience VMS during cancer treatment that includes hormone deprivation for:
Dr. Kelsey Mills MD, MSc HSEd, FRCSC, MSCP Education & Specialized Training • H BSc, Mount Allison University • MD, University of Toronto • Obstetrics and Gynecology Fellowship, University of Toronto • MSc HSEd, McMaster University • Complex Menopause Fellowship, University of Toronto • Menopause Certified Practitioner (The Menopause Society), 2013 - current Academic Appointments • Clinical Associate Professor, University of British Columbia • Affiliate Associate Professor, University of Victoria Professional Leadership • Board Member, Canadian Menopause Society • Advisory Board Member, Menopause Foundation of Canada • Expert Member, Society of Obstetricians and Gynecologists of Canada (Menopause) • Examination Committee Member, Royal College of Surgeons of Canada (Menopause) Clinical Practice • Current Consultant Obstetrician and Gynecologist, Island Health Authority, Vancouver Island • Current Consultant Obstetrician and Gynecologist, BC Women’s Complex Menopause Clinic
7 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 Phase 2 is a randomized, double-blind, placebo-controlled, multicenter trial in postmenopausal women Phase 2 Study Trial Design Participants N ~ 80 planned 92 postmenopausal women with moderate-to-severe VMS N=46 per cohort Key inclusion criteria Comparable to Phase 3 entry criteria for approved NK3R small molecules Age 40-75 years Endpoints VMS frequency, VMS severity, patient-reported outcome measures, safety, pharmacokinetics Efficacy analysis population/ Primary analysis methodology Intent to treat population at 4 weeks MMRM analyses except for patient global impression of change (Mann-Whitney U test) Study design Placebo-controlled treatment period ABCL635 600 mg SC (N=46) Placebo (N=46) Open-Label Extension 600 mg SC Optional open-label extension (OLE) Sc re en in g R NK3R: Neurokinin 3 Receptor; MMRM: Mixed Models for Repeated Measures; SC: subcutaneous. Clinicaltrials.gov ID: NCT07118891.
8 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 The moderate/severe VMS severity score is calculated as: (number of moderate hot flashes x 2) + (number of severe hot flashes x 3) / VMSM-S Frequency. The PGI-S is on a five-point scale ranging from "none" to "very severe". BMI: Body Mass Index; PGI-S: Patient Global Impression of Severity; SC: subcutaneous. NK3R: Neurokinin 3 Receptor; Data cutoff: 30JUL26 Demographic and baseline characteristics were well balanced ● Baseline characteristics, including severity of disease, consistent across treatment groups ● Baseline data comparable to studies of small molecule NK3R inhibitors Phase 2 Population ABCL635 (600 mg) Once Monthly, SC (N=46) Placebo Once Monthly, SC (N=46) Race, n (%) Asian 1 (2.2) 1 (2.2) Black 2 (4.3) 3 (6.5) White 43 (93.5) 42 (91.3) Age (years) Mean (Min, Max) 58.7 (47, 69) 59.7 (49, 71) BMI (kg/m2) Mean (Min, Max) 27.1 (20.8, 33.9) 27.4 (21.1, 34.9) Patient Global Impression of Severity (PGI-S), n (%) Mild 0 1 (2.2) Moderate 18 (39.1) 19 (41.3) Severe 22 (47.8) 18 (39.1) Very Severe 6 (13.0) 8 (17.4) Frequency of moderate/severe VMS, daily average Mean (Median) 10.6 (8.8) 9.8 (9.1) Moderate/severe VMS Severity Score, daily average Mean (Median) 2.4 (2.4) 2.4 (2.5) PROMIS-SD-SF-8b Total T-Score Mean (Median) 58.8 (57.8) 57.2 (56.3)
9 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 reduced the frequency of moderate and severe VMS starting at week 1 through week 4 MMRM: Mixed Models for Repeated Measures; LSM (SE): Least Squares Mean (Standard Error); VMSM-S: moderate and severe VMS Data cutoff: 30JUL26 Frequency of Moderate and Severe VMS ● Mean placebo-adjusted treatment difference of 2.6 at week 1 ● Mean placebo-adjusted treatment difference of 5.3 starting at week 4 ● Mean % change from baseline at week 4: ○ 83% reduction ABCL635 vs. 33% reduction placebo ○ placebo-adjusted difference of 50% ● Treatment effects consistent across subgroup and sensitivity analyses Primary MMRM analysis Sensitivity MMRM analysis
10 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 reduced the severity score of moderate and severe VMS starting at week 1 through week 4 MMRM: Mixed Models for Repeated Measures; LSM (SE): Least Squares Mean (Standard Error); VMSM-S: moderate and severe VMS. Data cutoff: 30JUL26 Severity Score of Moderate and Severe VMS ● Mean placebo-adjusted treatment difference of 0.3 at week 1 ● Mean placebo-adjusted treatment difference of 1.1 at week 4 ● Mean % change from baseline at week 4: ○ 58% reduction ABCL635 vs. 12% reduction placebo ○ placebo-adjusted difference of 46% ● Treatment effects consistent across subgroup and sensitivity analyses Primary MMRM analysis Sensitivity MMRM analysis
11 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 reduced the severity score of moderate and severe VMS starting at week 1 through week 4 ● Mean ABCL635 severity at week 4 = 1.0 (mild) ● Mean placebo severity at week 4 = 2.1 (moderate) SE: Standard Error; VMSM-S: moderate and severe VMS. Data cutoff: 30JUL26
12 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 participants fared better than placebo across all threshold values VMSM-S: moderate and severe VMS. Data cutoff: 30JUL26 Cumulative Distribution at Week 4 of VMS Moderate-to-Severe Frequency and Severity Scores VMS Frequency VMS Severity % Reduction from baseline at week 4 ABCL635 (N=46) % Participants Placebo (N=46) % Participants 100% 37.0% 2.2% >90% 60.9% 8.7% >75% 78.3% 15.2% >50% 87.0% 32.6% % Reduction from baseline at week 4 ABCL635 (N=46) % Participants Placebo (N=46) % Participants 100% 26.1% 2.2% >90% 28.3% 2.2% >75% 37.0% 2.2% >50% 58.7% 8.7%
13 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 significantly improved sleep starting at week 1 through week 4 PROMIS-SD-SF-8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b; LSM (SE): Least Squares Mean (Standard Error). Data cutoff: 30JUL26 PROMIS-SD-SF-8b Total T-Score Change from Baseline ● Significant treatment difference of -5.5 at week 4 ● Improvements observed across all 8 aspects of sleep disturbance including: ○ Trouble sleeping ○ Difficulty falling asleep ○ Difficulty staying asleep ○ Getting enough sleep ○ Restlessness ○ Sleep quality ○ Satisfaction with sleep ○ Feeling refreshed
14 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 84% of ABCL635 patients rated symptoms as “Much Better” or “Moderately Better” vs. 27% of placebo patients Data cutoff: 30JUL26 Patient Global Impression of Change (PGI-C) at Week 4 ● Significant differences observed as early as week 1 ● Benefits persisted throughout 4 weeks
15 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ● No SAEs or severe (Grade 3+) AEs in ABCL635 group ● 1 SAE and 2 severe (Grade 3) AEs in placebo group ● Headache AEs generally mild in both treatment groups ● Fatigue AEs all mild in ABCL635 group and mild/moderate in placebo group ● No evidence of gastrointestinal toxicity ● 1 ABCL635 AE of mild increase in transaminases (AST = 92; ALT = 66 IU/L), resolved in one week ● 1 placebo patient with ALT values up to 121 IU/L *Includes Headache and Tension headache ^ Includes injection site bruising, injection site reaction, injection site erythema, injection site hyperesthesia, injection site induration, and injection site pruritus. SAE: Serious Adverse Event; ALT: Alanine Aminotransferase; AST: Aspartate Aminotransferase; Data cutoff: 30JUL26 ABCL635 demonstrates a favorable tolerability profile Adverse Events (AEs) reported in at least two patients in either group regardless of relationship during first 4-weeks of treatment AE Preferred Term ABCL635 (600 mg) Once Monthly, SC (N=46) n (%) Placebo Once Monthly, SC (N=46) n (%) Number (%) with at least one AE 31 (67.4%) 24 (52.2%) Number (%) with at least one SAE 0 1 (2.2%) Number (%) with at least one grade 3+ AE 0 2 (4.3%) Headache* 13 (28.2%) 6 (13.0%) Fatigue 6 (13.0%) 3 (6.5%) Injection site reaction^ 4 (8.7%) 3 (6.5%) Nausea 2 (4.3%) 4 (8.7%) Nasopharyngitis 2 (4.3%) 3 (6.5%) Gastroesophageal reflux disease 2 (4.3%) 0 Urinary tract infection 2 (4.3%) 0 Diarrhea 0 3 (6.5%) Nasal congestion 1 (2.2%) 2 (4.3%) Abdominal pain 0 2 (4.3%) Arthralgia 0 2 (4.3%) Dizziness 0 2 (4.3%)
16 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 No liver safety signal observed to date Mean liver function tests (ALT, AST, bilirubin) remained stable Data are shown as mean ± SEM. The mean upper limit of normal (ULN) reported across all measurements is shown in the dotted lines. Data cutoff: 30JUL26 Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) Bilirubin
17 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 Phase 2 efficacy data are markedly improved compared to approved small molecule NK3R antagonists at week 4 *Veozah (fezolinetant) USPI, **Lynkuet (elinzanetant) USPI DISCLAIMER: Information provided above is for illustrative purposes only and no head-to-head clinical trials have been conducted. Differences exist between study or trial designs and subject characteristics, and caution should be exercised when comparing data across trials. VMS Moderate-to-Severe Frequency and Severity Placebo-Adjusted at Week 4 Frequency Severity ABCL635 SC 600 mg Fezolinetant 45 mg -Trial 1* Fezolinetant 45 mg -Trial 2* Elinzanetant 120 mg -Trial 1** Elinzanetant 120 mg -Trial 2** ABCL635 SC 600 mg Fezolinetant 45 mg -Trial 1* Fezolinetant 45 mg -Trial 2* Elinzanetant 120 mg -Trial 1** Elinzanetant 120 mg -Trial 2**
18 CO PY RI GH T © A BC EL LE RA AB CL 63 5 Ph as e 2 Cl in ic al U pd at e Q3 2 02 6 ABCL635 Phase 2 data indicate best-in-class potential and supports advancing to late-stage development Potential for best-in-class VMS efficacy EFFICACY ENDPOINT ● Additional data to be presented at major medical conferences later this year ● Completion of 12-week follow up to support optimal dose selection ● Regulatory interactions to discuss late-stage development in VMS due to menopause and oncology treatments NEXT STEPS Significant improvement in sleep and symptom burden Comprehensive improvement in sleep disturbance symptoms QUALITY OF LIFE ENDPOINT Significant reduction in both VMS frequency and severity vs. placebo after a single dose Favorable tolerability profile with no meaningful liver or gastrointestinal safety signal Potential for an improved safety profile SAFETY ENDPOINT
19 CO PY RI GH T © A BC EL LE RA THANK YOU