Ambrx Announces NovoCodex's Dosing of First Patient with ARX305, Ambrx's Investigational Antibody Drug Conjugate Targeting CD70

Ambrx Announces NovoCodex's Dosing of First Patient with ARX305, Ambrx's Investigational Antibody Drug Conjugate Targeting CD70

- ARX305 is being evaluated by Ambrx's partner, NovoCodex, in a Phase 1 clinical trial in various advanced tumors -

- First patient dosing triggers milestone payment to Ambrx -

- NovoCodex responsible for funding Ambrx's Phase 1 development of ARX305 -

Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using its proprietary Engineered Precision Biologics (EPBs) platform to create antibody drug conjugates (ADCs), today announced the first patient has been dosed by Ambrx's partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex) in its Phase 1 trial of ARX305 in patients with advanced solid tumors. ARX305 is the only anti-CD70 ADC in active development that targets CD70, a protein that is overexpressed in a broad range of solid and hematologic tumors, giving it the potential to treat a range of liquid and solid tumor cancers, where CD70 is overexpressed.

According to their development agreement, NovoCodex and Ambrx will collaborate in the development of ARX305 up until the completion of Phase 1 clinical trials. Under the terms of the development agreement, Ambrx is eligible to receive up to $4.0 million in clinical milestones, as well as tiered royalties in the low teens percentage range of aggregate net sales of ARX305 in China from NovoCodex. As a result of the first patient being dosed in NovaCodex's Phase 1 clinical trial in China, Ambrx will now receive a significant portion of the $4.0 million milestones payments.

Ambrx plans to leverage the safety data from NovoCodex's Phase 1 dose escalation clinical trial to inform its own Phase 1a trial, thereby efficiently using the company's cash and resources. Specifically, using the data gained from NovoCodex's dose escalation trial, Ambrx can reduce the expense of conducting its own initial dose escalation clinical trial. Building on the NovoCodex Phase 1 data, Ambrx plans to expedite its Phase 1a trial of ARX305 by starting at higher doses (i.e., doses closer to a recommended Phase 2 dose). Following the completion of NovoCodex's Phase 1 clinical trial, Ambrx's Phase 1a clinical trial for ARX305 is expected to initiate in the second half of 2023. NovoCodex is also responsible for funding a majority of Ambrx's development of ARX305 through the end of Phase 1 clinical trials, up to a certain cap, and will be able to leverage Ambrx's data in its own development of ARX305.

"The dosing of the first patient with ARX305 by NovoCodex represents an important strategic benchmark that will not only advance another Ambrx-generated ADC asset into the clinic, but also will allow us to leverage findings from the study to inform our own clinical trial," said Daniel O'Connor, Chief Executive Officer of Ambrx. "Leveraging partner data will both expedite internal development and cut costs, establishing a strong foundation from which to begin our own Phase 1 trial."

Mr. O'Connor added, "CD70 is highly expressed on the surface of a variety of hematological and solid tumor cells, and I believe the stability of ARX305 conferred by our proprietary EBP platform uniquely positions it as a potential best-in-class treatment for CD70 expressing tumors. I want to thank NovoCodex for continuing our strong partnership and look forward to continued progress as they advance ARX305 through the clinic."

About Ambrx Biopharma Inc. (Ambrx)

Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics. These include next generation antibody drug conjugates (ADCs) and other engineered therapies to modulate the immune system. Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety in multiple cancer indications, including its lead product candidate ARX517, a prostate-specific membrane antigen (PSMA) targeting ADC. In addition, Ambrx has clinical collaborations with multiple partners on drug candidates generated using Ambrx technology. For more information, please visit www.ambrx.com .

Forward-Looking Statements

This press release includes certain "forward-looking statements" intended to qualify for the "safe harbor" from liability established by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements may be identified by the words "anticipate," believe," "estimate," "expect," "intend," "plan," "project," "may," "will," "could," "should," "seek," "potential" and similar expressions, and include, without limitation, express or implied statements regarding Ambrx's beliefs and expectations regarding the advancement and potential benefits of its product candidates, clinical development and strategic plans, and the timing of program updates and milestones related to its product candidates. Forward-looking statements are based on Ambrx's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, those risks and uncertainties associated with: the continuing impact of the COVID-19 pandemic and other public health-related risks and events on Ambrx's business, operations, strategy, goals and anticipated milestones; Ambrx's ability to execute on its strategy including with respect to the timing of its R&D efforts, initiation of clinical trials and other anticipated milestones; risks associated with development of novel therapeutics, including potential delays in clinical trials and regulatory submissions and the fact that future clinical trial results may not be consistent with preliminary results or results from prior preclinical studies or clinical trials; Ambrx's ability to fund operations as anticipated; and the additional risks and uncertainties set forth more fully under the caption "Risk Factors" in Ambrx's Annual Report on Form 20-F filed with the United States Securities and Exchange Commission (SEC) on April 26, 2022, and elsewhere in Ambrx's filings and reports with the SEC. Forward-looking statements contained in this press release are made as of this date, and Ambrx undertakes no duty to publicly update or revise any forward looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law.

INVESTORS
Laurence Watts
Managing Director
Gilmartin Group, LLC.
619-916-7620
ir@ambrx.com

MEDIA
Mike Tattory
Account Supervisor
LifeSci Communications
media@ambrx.com

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- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced BOTOX ® Cosmetic's continued commitment to closing the Confidence Gap with the introduction of The Confidence Project: Empowering Women Entrepreneurs . The one & only BOTOX ® Cosmetic invites business owners to apply for this year's program starting today through May 9, 2025 at 11:59pm PT .

BOTOX® Cosmetic (onabotulinumtoxinA) Continues its Mission of Empowering Entrepreneurs Through

Women entrepreneurs continue to break barriers in the business world, with increasing efforts to close the Confidence Gap. When women founders are supported by mentors and have access to capital, they become agents of change. Seventy-one percent of businesswomen said their mentor was influential in their career advancement, with many using their income to uplift their families and community. 1

Since 2023, BOTOX ® Cosmetic has provided a total of $1 million dollars in grant funding across more than 40 founders, along with coaching and networking opportunities. This year, BOTOX ® Cosmetic is expanding to reach more founders by providing 250 entrepreneurs with access to The Confidence Project. Through a partnership with Hello Alice, an online platform that helps businesses launch and grow, each of the 250 entrepreneurs will participate in an intensive "Boostcamp" program, which will provide participants with skill-building, mentorship resources, and exclusive networking opportunities. After completing the course, they will leverage their newfound skills to pitch their business to a panel of aesthetic entrepreneurs, as well as key business leaders from Allergan Aesthetics and Hello Alice, for a chance to receive one of 20 $20,000 grants from BOTOX ® Cosmetic.

"BOTOX ® Cosmetic is committed to being a catalyst for confidence, whether that be by pursuing education, aesthetic treatment, or your entrepreneurial goals. Through The Confidence Project, we pledge to continue to uplift founders who've invested so much in their businesses," said Nicole Katz , Vice President, Customer Engagement and Corporate Affairs at Allergan Aesthetics. "We know when women have access to resources and capital, there's no limit to what they can achieve. We look forward to getting to know this year's cohort of founders and how they found the confidence to pursue their dreams."

"Our mission at Hello Alice is to help entrepreneurs access the funding, mentorship, and resources they need to succeed. BOTOX ® Cosmetic's The Confidence Project provides a powerful opportunity for women entrepreneurs to scale their businesses and create lasting change," said Elizabeth Gore , Co-Founder and President of Hello Alice. "Our partnership with BOTOX ® Cosmetic aims to foster long-term growth, confidence, and leadership for future generations of women in business, by investing in their success today."

Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact . Applicants must agree to the official rules of the grant program and submissions must be received by May 9, 2025 , at 11:59pm PT . The 250 women entrepreneurs selected to participate in the Hello Alice Boostcamp will be announced in July, and the 20 grant recipients will be announced in October 2025 .

For more information on The Confidence Project, visit www.botoxcosmetic.com/realimpact and follow @botoxcosmetic on Instagram and YouTube .

About Allergan Aesthetics
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.allerganaesthetics.com .

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn   ,   Facebook , Instagram , X (formerly Twitter) , and YouTube .

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BOTOX ® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults.

IMPORTANT SAFETY INFORMATION

BOTOX ® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX ® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, which can be severe and result in loss of life. You are at the highest risk if these problems are preexisting before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms, including loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

BOTOX ® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX ® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, forehead lines, and/or platysma bands.

BOTOX ® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX ® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX ® Cosmetic if you are allergic to any of the ingredients in BOTOX ® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg); or have a skin infection at the planned injection site. This list may not include all available botulinum toxin products.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing, from standard doses of BOTOX ® Cosmetic.

Tell your doctor about all your medical conditions, including surgery or plans to have surgery on your face, trouble raising your eyebrows, drooping eyelids, any other abnormal facial change, are pregnant or plan to become pregnant (it is not known if BOTOX ® Cosmetic can harm your unborn baby), or are breastfeeding or plan to (it is not known if BOTOX ® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX ® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX ® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, or Letybo in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; or take aspirin-like products or blood thinners.

Other side effects of BOTOX ® Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems, including double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of eyelids, and dry eyes.

For more information, refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan Aesthetics at 1-800-678-1605.

Please see BOTOX ® Cosmetic full Prescribing Information , including Boxed Warning and Medication Guide .

References:

  1. Barbara Kurshan. Forbes.com. Purpose-Driven Women: Unleash Your Potential Through Mentorship. 2023 https://www.forbes.com/sites/barbarakurshan/2023/06/13/purpose-driven-women-unleash-your-potential-through-mentorship/

© 2025 AbbVie. All rights reserved. BOTOX Cosmetic and its designs are trademarks of Allergan Holdings France SAS, an AbbVie company, or its affiliates.

Contacts:

Investors:
Liz Shea
Liz.Shea@AbbVie.com
(847) 935-2211

Media:
Ember Garrett
Ember.Garrett@allergan.com
(714) 246-3525

Business owners and their cofounders interested in applying to The Confidence Project are encouraged to visit www.botoxcosmetic.com/realimpact.

Allergan Aesthetics (PRNewsfoto/AbbVie)

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SOURCE AbbVie

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