Ambrx Biopharma Inc

Ambrx Biopharma Inc. operates as a clinical-stage biologics company. It focuses on discovering and developing a novel class of engineered precision biologics using its proprietary expanded genetic code technology platform that allows it to incorporate, in a site-specific manner, synthetic amino acids that do not exist in nature into proteins within living cells. The company was founded in January 2003 and is headquartered in La Jolla, CA.

Earnings data Q1 2024

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Ambrx Biopharma, Inc. is a clinical-stage biologics company, which engages in discovering and developing a novel class of engineered precision biologics (EPBs). Using its proprietary expanded genetic code technology platform, it allows incorporating synthetic amino acids (SAAs) into proteins within living cells. Its product pipeline includes ARX788, ARX517, and ARX305. The company was founded on August 11, 2023 and is headquartered in La Jolla, CA.

Cohort 9 Following completion of the 21-day observation period at 3.4 mg/kg (Cohort 9), no dose limiting toxicities (DLTs) or serious adverse events (SAEs) were observed Two patients in Cohort 9 experienced rapid PSA reduction at three weeks post-treatment following the first ARX517 dose Cohort 8 The cohort (2.88 mg/kg) is now fully enrolled with 20 patients Recommended phase 2 dose expected by early next year SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx (NASDAQ: AMAM), today announced a clinical update regarding its proprietary anti-PSMA antibody drug conjugate (ADC) ARX517 in the ongoing APEX-01 Phase 1 / 2 dose escalation and dose expansion clinical trial in metastatic castration-resistant prostate cancer (mCRPC). Following the completion of the 21-day DLT observation period from APEX-01 dose escalation Cohort 9 (3.4 mg/kg), no DLTs or SAEs were observed.

Ambrx Provides Update On APEX-01, an On-Going Phase 1 / 2 Dose Escalation Study Evaluating ARX517, a Proprietary PSMA-Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer

Ambrx Biopharma Inc. common stock experienced an irrational selloff following the Phase 1/2 ESMO data release for its ADC candidate ARX517, presenting a buying opportunity. The company's technology for next-generation ADCs has shown safety benefits and potential efficacy, making it an attractive acquisition candidate. ARX788, an ADC candidate for metastatic breast cancer, alone has the potential to drive a significant upside for Ambrx stock.

Ambrx: Next-Generation Antibody-Drug Conjugates, Buying The Dip After ESMO Data

Ambrx Biopharma Inc. updated data of ARX517 for the treatment of patients with mCRPC shows encouraging anti-tumor activity with cohorts 6 through 8. In order to see if ARX517 can be improved upon for these patients with mCRPC, expansion of cohort 8 is underway and then dose escalation of cohort 9 was initiated. The global prostate cancer market size is expected to reach $27.51 billion by 2032; 10% to 50% of prostate cancer cases progress to the metastatic castration-resistant state of disease.

Ambrx Biopharma: Potential With Recently Released Prostate Cancer Data

Newly published data from the Phase 1 portion of the on-goingPhase 1 / 2 APEX-01 trial provide the following key points: Multiple efficacy endpoints demonstrate consistent and promising anti-cancer activity at therapeutic doses of 2.0 – 2.88 mg/kg (Cohorts 6-8) in heavily pretreated patients (median of 4 and maximum of 13 prior lines of therapy): 52% (12/23) of patients experienced a ≥50% PSA reduction 81% (17/21) of patients experienced ≥50% circulating tumor DNA reduction 50% (3/6) of patients with prior PSMA-targeted radionuclide therapy (TRT) experienced a ≥50% PSA reduction 50% (2/4) experienced a >30% reduction in target lesion(s) A strong and highly differentiated safety profile observed across 65 patients at all dose levels with no treatment-related SAEs or DLTs SAN DIEGO, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that in biomarker unselected patients ARX517 monotherapy demonstrated a strong antibody-drug conjugate (ADC) safety profile at all doses tested with promising early efficacy signals that included PSA50 declines, ctDNA reductions, and RECIST v1.1 tumor response. The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx's on-going trial, APEX-01 (NCT04662580).

Ambrx Announces ARX517, a PSMA-Targeted ADC, Demonstrates a Promising 52% PSA50 (≥50% Reduction) and a Highly Differentiated Safety and PK Profile in Patients with mCRPC, who Progressed on Multiple FDA-Approved Treatments

Newly published abstract regarding dose escalation patients provides key updates including: ≥50% PSA reduction observed across putative therapeutic dose levels ≥2.0 mg/kg – 3 of 3 in Cohort 6 (2.0 mg/kg), 2 of 3 in Cohort 7 (2.4 mg/kg) and 2 of 3 in Cohort 8 (2.88 mg/kg) No drug-related severe adverse events (SAEs) and no dose limiting toxicities (DLTs) observed in any cohort Pharmacokinetic (PK) data indicated strong ADC stability preventing premature release of anticancer payload Ambrx to host a live event / webcast to discuss additional data presented at ESMO on Sunday, October 22, 2023, at 8 p.m. CEST / 2 p.m.

Ambrx Provides Safety and Efficacy Data from Ongoing Phase 1/2 APEX-01 Trial of ARX517 in mCRPC at ESMO Congress

In-person event and virtual webcast to be held on Sunday, October 22, 2023 at 8:00pm CEST / 2:00pm ET In-person event and virtual webcast to be held on Sunday, October 22, 2023 at 8:00pm CEST / 2:00pm ET

Ambrx to Host KOL Event Discussing ARX517 Data Presented at ESMO Congress 2023

The company, formerly based in the Cayman Islands, is moving to Delaware. It is expected to announce trial data next week regarding two of its lead therapies.

Why Shares of Ambrx Biopharma Soared This Week

SAN DIEGO, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that Daniel J. O'Connor, Chief Executive Officer and President of Ambrx, will present a corporate overview and participate in one-on-one meetings at the Baird Global Healthcare Conference and the Morgan Stanley 21st Annual Global Healthcare Conference, both being held in New York, NY. The presentations will focus on the status of Ambrx's lead clinical candidates, ARX788 and ARX517.

Ambrx to Present at the Baird and Morgan Stanley Global Healthcare Conferences

Ambrx is no longer flying under the radar. Instead, AMAM stock has soared 483% this year as enthusiasm grows for its cancer smart bombs.

Ambrx Biopharma Has Surged 483% This Year. But It Could Just Be Getting Started.

Here is how Ambrx Biopharma Inc. Sponsored ADR (AMAM) and Sientra (SIEN) have performed compared to their sector so far this year.

Is Ambrx Biopharma (AMAM) Outperforming Other Medical Stocks This Year?

Ambrx Biopharma is a clinical-stage biotech company developing precision biologics for cancer treatment. They have a strong financial position with $235.1 million in liquid assets and a cash runway of approximately four years. Their leading candidates, ARX788 and ARX517, show promising results in clinical trials for breast cancer and prostate cancer, respectively.

Promising Developments In Ambrx's Engineered Precision Biologics

Presentations represent the first time clinical data regarding ARX517 will be presented at a medical meeting Presentations represent the first time clinical data regarding ARX517 will be presented at a medical meeting

Ambrx to Present Preliminary ARX517 First-in-Human Safety, Efficacy, and Pharmacokinetics Data at ESMO 2023

SAN DIEGO, July 19, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ambrx's proprietary anti-PSMA antibody-drug conjugate (ADC) investigational therapy, ARX517, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) upon progression on an androgen receptor pathway inhibitor. Fast Track designation is a process designed to facilitate the development and expedite the review of drugs which may demonstrate substantial improvement over available therapy for serious conditions with unmet medical need.

FDA Grants Fast Track Designation for Ambrx's ARX517 for the Treatment of Metastatic Castration-Resistant Prostate Cancer

SAN DIEGO, June 28, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., or Ambrx (or the “Company”) (NASDAQ: AMAM), today announced the closing of its previously announced market-priced registered direct offering of approximately $75 million (the “Offering”) of its American Depositary Shares of the Company (“ADS”) at a price of $13.93 per ADS. The Offering was priced based on the 5-day trailing VWAP for the ADS on the effective date of the purchase agreement related to the Offering.

Ambrx Announces Closing of $75 Million Market Priced Registered Offering

SAN DIEGO, June 05, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., or Ambrx (NASDAQ: AMAM), today announced the appointment of Jared Kelly as Senior Vice President, General Counsel and Corporate Secretary. After practicing for more than ten years at large corporate law firms, Mr. Kelly brings his extensive experience advising public companies on corporate governance, financing transactions and mergers and acquisitions to Ambrx. He will be responsible for developing and overseeing the legal strategy of the Company and for providing legal guidance to the Company's board of directors, executive management team and other business units.

Ambrx Appoints Jared Kelly as General Counsel

SAN DIEGO, May 30, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., or Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that Daniel J. O'Connor, Chief Executive Officer and President of Ambrx, will present a corporate overview at the TD Cowen Oncology Innovation Summit, the Jefferies Healthcare Conference, and the Goldman Sachs 44th Annual Global Healthcare Conference in the coming weeks. The presentations will focus on the status of Ambrx's clinical development strategy and an update on the progress of its lead clinical candidates, ARX788 and ARX517.

Ambrx to Present at Multiple Upcoming Investor Meetings

SAN DIEGO, May 24, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., or Ambrx (or the “Company”) (NASDAQ: AMAM), today announced that it has entered into a securities purchase agreement with clients managed by Darwin Global Management Ltd. (“Darwin”) for the sale of an aggregate of approximately 5.4 million American Depositary Shares of the Company (“ADS”) at a price of $13.93 per ADS, which is based on the 5-day trailing VWAP for the ADS, pursuant to a registered direct offering (the “offering”). In connection with the offering, Darwin has agreed not to sell any of the Company's securities it holds for a period of six months following the closing of the offering.

Ambrx Announces $75 Million Market Priced Registered Offering

Ambrx Biopharma's stock value has surged due to positive preliminary data from cancer-targeting clinical trials of ARX788 and ARX517. With cash reserves increasing to $149.6 million in Q1 2023, Ambrx can continue developing its innovative cancer treatments.

Ambrx Biopharma: ARX788's Potential In Cancer Treatment Presents Promising Opportunity

Ambrx's lead therapies target breast cancer and prostate cancer, two of the most common forms of cancer. The company has enough cash, it said, to fund operations for another year.

Why Shares of Ambrx Biopharma Jumped This Week

SAN DIEGO, May 18, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., or Ambrx (NASDAQ: AMAM), today announced that Stephen Glover has joined the Company's Board of Directors as Chairman. Mr. Glover has extensive experience building successful biopharmaceutical companies, with a focus on pharmaceutical business strategy, corporate development, product development, commercialization, and business optimization. The Company's former Chair, Katrin Rupalla, Ph.D., has resigned from Ambrx's Board of Directors to pursue another opportunity, which precludes her ability to serve on any boards of directors.

Ambrx Appoints Stephen Glover as Chairman of its Board of Directors

Ambrx Biopharma Inc. is up 40x since February after posting positive clinical data. However, that sort of rally makes a stock unstable.

Ambrx Biopharma: Very Strong Rally On Positive Data, But Unstable Price

SAN DIEGO, May 11, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., or Ambrx (NASDAQ: AMAM), today announced that Daniel J. O'Connor, Chief Executive Officer and President of Ambrx, will present a corporate overview at the JMP Securities Life Sciences Conference and RBC Capital Markets Global Healthcare Conference taking place in New York City on May 16th and 17th, respectively. The presentations will focus on the status of Ambrx's clinical development strategy and an update on the progress of its lead clinical candidates, ARX788 and ARX517.

Ambrx to Present at JMP Securities Life Sciences and RBC Capital Markets Global Healthcare Conferences

Three posters will be presented at AACR and include data from preclinical studies of ARX517 and ARX305 and Trial in Progress Poster on APEX-01 Three posters will be presented at AACR and include data from preclinical studies of ARX517 and ARX305 and Trial in Progress Poster on APEX-01

Ambrx to Present Preclinical Data on ARX517 and ARX305 at the 2023 AACR Annual Meeting

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SAN DIEGO--(BUSINESS WIRE)--Ambrx Biopharma Inc., or Ambrx (NYSE: AMAM), today announced that it has completed net sales of approximately $78 million of American Depositary Shares (“ADSs”) pursuant to the Company's at-the-market (“ATM”) program established on Aug 5, 2022, through Cowen and Company LLC (“TD Cowen”), acting as sales agent. The ATM program had an aggregate offering price of up to $80 million in gross proceeds.

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