Pharmaceutics International, Inc.

GEORGETOWN, Texas--( BUSINESS WIRE )--AustinPx, developers of the next generation amorphous dispersion platform, KinetiSol™ Technology, and a contract development and manufacturing organization (CDMO), today announced that Elizabeth Hickman, chief business officer, will succeed Tim Scott in January 2025 as president and CEO of AustinPx. Scott has led the company’s new direction as a CDMO since 2022, successfully positioning the company’s leadership as an oral drug delivery dosage form development CDMO. Scott will stay on as executive chair following the transition and Hickman will be named to the Board of Directors. “On behalf of the board, I want to thank Tim for his valuable contributions to AustinPx. His outstanding leadership skillfully pivoted AustinPx from a technology-focused pharmaceutical company to a technology driven CDMO and has laid a strong foundation for our future success,” said Shaun Kirkpatrick, president, Research Corporation Technologies and board chair of AustinPx. “Elizabeth has an intimate understanding of AustinPx’s business and our industry. She has executed on our most important priorities, including strengthening our brand, building our CDMO customer base and attracting more than 30 new molecules into our KinetiSol platform for solubility enhancement since joining in May 2022.” “It has been such a privilege to serve as CEO of AustinPx. In just over a year, we have transformed from a pharma development company with a disruptive KinetiSol technology, into a revenue generating CDMO. I am so proud of what this team has accomplished in a very short period of time,” said Scott. “KinetiSol is going to revolutionize small molecule drug development and this team is well-positioned to make that happen,” said Scott. “Elizabeth understands and appreciates the Company's unique potential to solve the pharmaceutical industry’s ever increasing solubility hurdles. She has a proven track record of delivering results, and tremendous leadership abilities.” Hickman brings almost 20 years of CDMO experience to her role as CEO. She has been a key performer and leader with organizations such as West Pharmaceutical Services, Catalent, Pharmatek, Pii, and PharmaForm. Since joining AustinPx in 2022 as chief business officer, Elizabeth has played a critical role in driving AustinPx’s strategic growth, brand-building and fostering client relationships. “I am honored to lead AustinPx as we continue to drive innovation and provide exceptional services to our clients. I look forward to building upon the strong foundation laid by Tim and working collaboratively with the talented team at AustinPx to achieve our strategic goals,” said Hickman. “There is a huge opportunity in front of us to grow AustinPx into a world-class CDMO that also offers KinetiSol, which is well positioned to disrupt the commercial spray drying industry. We will continue to connect with drug developers to advance their pharmaceutical candidates, offering them outstanding service and advanced development expertise.” About AustinPx AustinPx, Pharmaceutics and Manufacturing, is a contract development and manufacturing organization (CDMO) providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. AustinPx specializes in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol™ Technology. For more information, visit www.AustinPx.com .

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx (NASDAQ: AMAM), today announced that it has entered into a definitive agreement pursuant to which Johnson & Johnson will acquire all of the outstanding shares of Ambrx for $28.00 per share in cash, representing an approximately 105% premium to Ambrx’s closing stock price on January 5, 2024, for a total equity value of approximately $2.0 billion. “We are excited to reach this agreement with Johnson & Johnson for advancing scientific research to treat cancers with high unmet needs,” said Daniel J. O’Connor, Chief Executive Officer of Ambrx. “With our deep and unique knowledge of precision engineering of protein therapeutics enabled by our proprietary technology incorporating synthetic amino acids in living cells, Ambrx has developed next-generation novel drug candidates such as site-specifically conjugated highly stable antibody drug conjugates. Through this transaction, we will continue to advance our leading prostate cancer candidate and Ambrx’s promising pipeline, while delivering significant and certain cash value to our shareholders. This announcement is the culmination of two decades of scientific work, combined with the Ambrx team’s talent, hard work and innovation. I look forward to what Ambrx will achieve as part of Johnson & Johnson.” Ambrx’s proprietary Antibody Drug Conjugate (ADC) technology incorporates the advantages of highly specific targeting monoclonal antibodies securely linked to a potent chemotherapeutic payload to achieve targeted and efficient elimination of cancer cells without the prevalent side-effects typically associated with chemotherapy. Building on a legacy of innovation in oncology and in prostate cancer, Johnson & Johnson scientists intend to work with Ambrx researchers, accelerating the Phase 1/2 APEX-01 study (NCT04662580) of ARX517 in advanced prostate cancer, while progressing a pipeline of novel product candidates. The transaction, which was unanimously approved by the Ambrx Board of Directors, is expected to close in the first half of 2024, subject to customary closing conditions, including approval by Ambrx shareholders and clearance under the Hart-Scott-Rodino Antitrust Improvements Act. Advisors Centerview Partners LLC is acting as lead financial advisor and Cantor Fitzgerald & Co. is acting as financial advisor to Ambrx; Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel. About Ambrx Biopharma, Inc. Ambrx is a clinical-stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop 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 ARX517, its proprietary ADC targeting the prostate-specific membrane antigen (PSMA) and ARX788, its proprietary ADC targeting HER2. In addition, Ambrx has preclinical and clinical collaborations with multiple partners on drug candidates generated using Ambrx technology. Ambrx was spun out of The Scripps Research Institute in 2003 and has several other product candidates involving ADCs and other aspects of Ambrx’s protein engineering technology. For more information, please visit www.ambrx.com. Ambrx routinely posts information that may be important to investors on its website. Forward-Looking Statements This communication 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, including, but not limited to, statements regarding the proposed transaction. Forward-looking statements may be identified by the words “intend,” “plan,” “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “believe,” “will” and similar expressions, are based on Ambrx’s current expectations, and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Accordingly, you should not place undue reliance on any forward-looking statements contained herein. Factors that could cause actual results and outcomes to differ include, but are not limited to, the following risks and uncertainties relating to the proposed transaction: the occurrence of any event, change, or other circumstances that could give rise to the termination of the merger agreement; the satisfaction of closing conditions to the transaction on a timely basis or at all, including the ability to obtain required regulatory and shareholder approvals; uncertainties as to the timing of the transaction; the possibility that competing offers will be made; litigation relating to the transaction; the impact of the transaction on Ambrx’s business operations; incurrence of unexpected costs and expenses in connection with the transaction; financial or other setbacks if the transaction encounters unanticipated problems; and the risks that the proposed transaction diverts management’s attention from Ambrx’s ongoing business operations. Other important factors that could cause actual results and outcomes to differ materially from those expressed or implied include, but are not limited to, risks related to: Ambrx’s ability to execute on its strategy, including with respect to its R&D efforts, initiation of clinical trials and other anticipated milestones; the development and marketing approval of novel therapeutics, including potential delays in clinical trials and regulatory submissions and the fact that future clinical trial results/data may not be consistent with interim, initial or preliminary results/data or results/data 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 Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on November 13, 2023, and elsewhere in Ambrx’s reports filed with the SEC. Forward-looking statements contained in this communication 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. Additional Information and Where to Find it In connection with the proposed acquisition of Ambrx by Johnson & Johnson, Ambrx intends to file a preliminary and definitive proxy statement. The definitive proxy statement and proxy card will be delivered to the shareholders of Ambrx in advance of the special meeting relating to the proposed acquisition. This communication is not a substitute for the proxy statement or any other document that may be filed by Ambrx with the SEC. AMBRX’S SHAREHOLDERS AND INVESTORS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF JOHNSON & JOHNSON AND AMBRX WITH THE SEC IN CONNECTION WITH THE PROPOSED ACQUISITION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED ACQUISITION AND THE PARTIES TO THE PROPOSED ACQUISITION. Investors and security holders will be able to obtain a free copy of the proxy statement and such other documents containing important information about Johnson & Johnson and Ambrx, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Johnson & Johnson and Ambrx make available free of charge at Johnson & Johnson’s website at www.investor.jnj.com and Ambrx’s website at www.ir.ambrx.com, respectively, copies of materials they file with, or furnish to, the SEC. In addition, the proxy statement and other documents filed by Ambrx with, or furnished to, the SEC (when available) may be obtained from Ambrx free of charge by directing a request to Ambrx’s Investor Relations at ir@ambrx.com. Participants in the Solicitation This communication does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities. Ambrx and its directors, executive officers and employees, including Stephen Glover, Kate Hermans, Janet Loesberg, Pharm. D, Paul Maier, and Margaret Dalesandro, Ph. D., all of whom are members of Ambrx’s Board of Directors, as well as Daniel O’Connor, President, Chief Executive Officer and Director of Ambrx, Andrew Aromando, Chief Operating Officer of Ambrx, and Sonja Nelson, Chief Financial Officer of Ambrx, may be deemed to be participants in the solicitation of proxies from the shareholders of Ambrx in connection with the proposed acquisition. Information regarding Ambrx’s directors and executive officers is contained in (i) the “Directors, Executive Officers and Corporate Governance,” “Executive Compensation” and “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters” sections of the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 of Ambrx Biopharma Inc., a Cayman Islands exempted company and the predecessor registrant to Ambrx (the “Predecessor Registrant”), which was filed with the SEC on March 30, 2023, (ii) the “Proposal 1 – Election of Director,” “Executive Officers,” “Security Ownership of Certain Beneficial Owners and Management” and “Executive Compensation” sections of the definitive proxy statement for the 2023 annual general meeting of shareholders of the Predecessor Registrant, which was filed with the SEC on April 28, 2023, and (iii) the “Security Ownership of Certain Beneficial Owners and Management” and “Executive and Director Compensation” sections of the definitive proxy statement for an extraordinary general meeting of the Predecessor Registrant, which was filed with the SEC on September 15, 2023 (the “September 2023 Proxy Statement”). Any change of the holdings of Ambrx’s securities by its directors or executive officers from the amounts set forth in the September 2023 Proxy Statement have been reflected in the following Initial Statements of Beneficial Ownership on Form 3 or Statements of Beneficial Ownership on Form 4 filed with the SEC: Form 4s, filed by Daniel J. O'Connor, with the filings of the Predecessor Entity on July 7, 2023 and with the filings of Ambrx on October 31, 2023 and December 11, 2023; Form 4s, filed by Sonja Nelson, with the filings of the Predecessor Entity on July 7, 2023, and with the filings of Ambrx on October 31, 2023 and December 11, 2023; Form 4s, filed by Andrew Aromando, with the filings of the Predecessor Entity on July 7, 2023 and with the filings of Ambrx on December 11, 2023; Form 3, filed by Margaret Dalesandro, with the filings of the Predecessor Entity on September 6, 2023; and Form 4, filed by Margaret Dalesandro, with the filings of the Predecessor Entity on September 6, 2023. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be included in the definitive proxy statement relating to the proposed acquisition when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and Ambrx’s website at www.ambrx.com. Contacts INVESTORSMike MoyerLifeSci Advisors617-308-4306mmoyer@lifesciadvisors.com MEDIANick Lamplough / Dan Moore / Tali EpsteinCollected StrategiesAMAM-CS@collectedstrategies.com

Company plans to initiate clinical trials in September 2023 to compare Sildenafil Oral Spray to Viagra® tablets, and effect of dose administration under fasted versus fed conditionsRepresents Aspargo’s first program to receive IND clearance ENGLEWOOD CLIFFS, N.J., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Aspargo Laboratories, Inc. (“Aspargo” or the “Company”), a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate bioequivalence and food-effect clinical studies of ASP-001 (Sildenafil Oral Spray) in comparison to Viagra® for the treatment of erectile dysfunction (“ED”). “We are thrilled to have received IND clearance from the FDA for Sildenafil Oral Spray for the treatment of ED. This significant milestone brings us one step closer to introducing in the US a disruptive and paradigm-shifting route of administration for this popular medication,” said Michael Demurjian, Chief Executive Officer of Aspargo. “This program marks our first IND clearance as a company and is a testament to Dr. Rober Niecestro, head of regulatory affairs at Aspargo, and the formulation optimization and CMC data provided by our contract manufacturer, Pharmaceutics International Inc. (“Pii”) and regulatory data developed by our regulatory teams at Pii, QARA and Propharma, which support ASP-001 and our IND submission. We look forward to launching our clinical studies designed to compare Sildenafil Oral Spray to Viagra® tablets later this month through our contract research organization, Cliantha Research, at Cliantha’s Mississauga, Ontario clinic.” Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5mg of sildenafil per push. Aspargo uses a metered-dose container that delivers the precise amount of sildenafil citrate per actuation based on patient need. The discreet and easy-to-carry oral spray allows for physician prescribed customized dosing and avoids splitting or crushing pills, which is common with the traditional tablet medication. Erectile dysfunction is characterized by the persistent difficulty achieving and maintaining an erection sufficient to have sexual intercourse. While the prevalence of ED has been shown to increase with age, a study conducted by the Sexual Medicine and Andrology Unit at the University of Florence, Italy1, showed that ED in younger men is likely to be overlooked and dismissed without a proper medical assessment, indicating a continued unmet medical need, and demand for new and innovative routes of administration of ED therapeutic products. ABOUT ASPARGO LABORATORIES, INC. Aspargo Laboratories, Inc., located in Englewood Cliffs, New Jersey, is a commercial stage, specialty pharmaceutical company. Aspargo’s current focus is to commercialize an oral spray formulation of sildenafil citrate, the active ingredient in Viagra®. Aspargo is the exclusive licensee of the patent rights covering Sildenafil Spray for the US and many international markets from Farmalider, S.A. (www.farmalider.com). For additional information, please visit our website at aspargolabs.com. FORWARD-LOOKING STATEMENTS All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; and the outcome of pending or future litigation or arbitration. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law. Contact: Aspargo Laboratories, Inc.(201) 408-4831info@aspargolabs.com 1 1Rastrelli G, Maggi M. Erectile dysfunction in fit and healthy young men: psychological or pathological? Transl Androl Urol. 2017 Feb;6(1):79-90. doi: 10.21037/tau.2016.09.06. PMID: 28217453; PMCID: PMC5313296