1. SOUTH SAN FRANCISCO, Calif., April 06, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 2,875,000 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase 375,000 additional shares of its common stock, at a public offering price of $42.00 per share. All of the shares of common stock were offered by AMT. The aggregate gross proceeds to AMT from the offering were approximately $120.8 million, before deducting underwriting discounts and commissions and other offering expenses.

    BofA Securities, Jefferies, and SVB Leerink acted as joint book-running…

    SOUTH SAN FRANCISCO, Calif., April 06, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced underwritten public offering of 2,875,000 shares of its common stock, which includes the exercise in full of the underwriters' option to purchase 375,000 additional shares of its common stock, at a public offering price of $42.00 per share. All of the shares of common stock were offered by AMT. The aggregate gross proceeds to AMT from the offering were approximately $120.8 million, before deducting underwriting discounts and commissions and other offering expenses.

    BofA Securities, Jefferies, and SVB Leerink acted as joint book-running managers for the offering.

    The registration statement relating to these securities became effective on March 31, 2021. The offering was made only by means of a prospectus, copies of which may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at ; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105, or by email at  A copy of the registration statement can be accessed through the SEC's website at www.sec.gov.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  2. SOUTH SAN FRANCISCO, Calif., March 31, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering of 2,500,000 shares of its common stock at a public offering price of $42.00 per share. All of the shares of common stock are being offered by AMT. In addition, AMT has granted the underwriters a 30-day option to purchase up to an additional 375,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds to AMT from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AMT, are expected to be $105.0…

    SOUTH SAN FRANCISCO, Calif., March 31, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering of 2,500,000 shares of its common stock at a public offering price of $42.00 per share. All of the shares of common stock are being offered by AMT. In addition, AMT has granted the underwriters a 30-day option to purchase up to an additional 375,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions. The gross proceeds to AMT from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AMT, are expected to be $105.0 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on April 6, 2021, subject to the satisfaction of customary closing conditions.

    BofA Securities, Jefferies, and SVB Leerink are acting as joint book-running managers for the offering.

    The registration statement relating to these securities became effective on March 31, 2021. The offering is made only by means of a prospectus, copies of which may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at ; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105, or by email at  Copies of the final prospectus, when available, related to the offering will be available at www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on AMT's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause AMT's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Such forward-looking statements include, among other things, statements regarding the timing, size and completion of the public offering of common stock. The forward-looking statements contained herein are based upon AMT's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the offering, and other risks. These and other risks are described more fully in AMT's registration statement on Form S-1 filed with the U.S. Securities and Exchange Commission ("SEC") on March 29, 2021 and the prospectus included therein, as well as AMT's other filings with the SEC from time to time, including its Annual Report on Form 10-K filed with the SEC on March 19, 2021. Except to the extent required by law, AMT undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors

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  3. SOUTH SAN FRANCISCO, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of 2,500,000 shares of its common stock. All of the shares in the proposed offering will be sold by AMT. In addition, AMT expects to grant the underwriters a 30-day option to purchase up to an additional 375,000 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering.

    BofA Securities, Jefferies, and SVB Leerink are acting…

    SOUTH SAN FRANCISCO, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of 2,500,000 shares of its common stock. All of the shares in the proposed offering will be sold by AMT. In addition, AMT expects to grant the underwriters a 30-day option to purchase up to an additional 375,000 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering.

    BofA Securities, Jefferies, and SVB Leerink are acting as joint book-running managers for the proposed offering.

    A registration statement relating to the securities has been filed with the Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

    The proposed offering will be made only by means of a preliminary prospectus, copies of which may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at ; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6105, or by email at .

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on AMT's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause AMT's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Such forward-looking statements include, among other things, statements about the potential of, and expectations regarding AMT's technology platform, statements regarding AMT's pipeline of product candidates, statements regarding the timing, size and completion of the proposed public offering of common stock and granting the underwriters a 30-day option to purchase additional shares. The forward-looking statements contained herein are based upon AMT's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to risks and uncertainties related to market conditions and satisfaction of customary closing conditions related to the proposed offering, and other risks. These and other risks are described more fully in AMT's registration statement on Form S-1 filed with the SEC on March 29, 2021 and the prospectus included therein, as well as AMT's other filings with the SEC from time to time, including its Annual Report on Form 10-K filed with the SEC on March 19, 2021. Except to the extent required by law, AMT undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  4. Company continues to strengthen key functions of corporate leadership

    Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program beginning in the second half of 2021

    Company expanded clinical pipeline with second program, oral AMT-126, and announced first subject dosed in Phase 1a trial in February 2021

    SOUTH SAN FRANCISCO, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that it has appointed Earl Douglas as General Counsel. In his new role, Earl will assume leadership responsibilities for all legal activities of the Company. He will become a member…

    Company continues to strengthen key functions of corporate leadership

    Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program beginning in the second half of 2021

    Company expanded clinical pipeline with second program, oral AMT-126, and announced first subject dosed in Phase 1a trial in February 2021

    SOUTH SAN FRANCISCO, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that it has appointed Earl Douglas as General Counsel. In his new role, Earl will assume leadership responsibilities for all legal activities of the Company. He will become a member of the AMT Executive Team, reporting to chief executive officer and co-founder of AMT, Tahir Mahmood, Ph.D.

    "I am delighted to welcome Earl as our general counsel and latest member of our executive management team," stated Tahir Mahmood, Ph.D. "Earl brings extensive legal and strategic advisory experience that will be invaluable as we continue to advance our promising pipeline of novel, oral biologic medicines. He is joining AMT at a critical time for the company, as we look forward to sharing top-line oral AMT-101 data readouts from the four Phase 2 trials from our comprehensive clinical program beginning in the second half of 2021 and as our second program, oral AMT-126, progresses through the clinic."

    Mr. Douglas joins with more than 30 years of deep experience, leading and building legal organizations for biotechnology and medical device organizations. Mr. Douglas most recently served as general counsel at Kiverdi. He has also served as general counsel and corporate secretary at BioMimetic Therapeutics (acquired by Wright Medical Group), Spinal Dynamics (acquired by Medtronic), and OPX Biotechnologies (acquired by Cargill). He also previously served as Counsel at Wilson Sonsini Goodrich & Rosati, and earlier in his career, practiced as an associate with Weil, Gotshal & Manges.

    Mr. Douglas earned a B.S. in chemical engineering from the Massachusetts Institute of Technology and holds a J.D. from Columbia University School of Law.

    "I am thrilled to be joining AMT at such an important point in the Company's growth," said Earl Douglas, general counsel of AMT. "I look forward to supporting the Company's future progress with this accomplished team."

    About AMT-101

    AMT-101 is a novel GI-selective, oral fusion of hIL-10 and AMT's proprietary carrier molecule, which is currently being developed in four Phase 2 clinical trials in inflammatory bowel diseases and rheumatoid arthritis. AMT-101 is designed to cross the intestinal epithelium barrier with limited entry into the bloodstream, thereby focusing hIL-10 at the primary site of inflammation for UC and potentially avoiding the side effects observed with systemic administration. By design, AMT-101 is actively transported through the IE barrier into the GI tissue, the primary site of inflammation in UC.

    About AMT-126

    AMT-126 is a novel GI-selective, oral fusion of hIL-22 and AMT's proprietary carrier molecule currently in development for diseases related to intestinal epithelial (IE) barrier defects. IL-22 is a cytokine that repairs structural and functional defects of the IE barrier and induces microbial defense. AMT-126 is designed to act locally on the epithelial cells of the intestinal tissue, thereby repairing the IE barrier and supporting mucosal healing, potentially translating into clinically meaningful improvements in a broad range of GI-focused, peripheral inflammatory and other diseases.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or AMT's future plans, strategy and performance. Such statements include, but are not limited to, the potential of, and expectations regarding AMT's technology platform, AMT-101 and AMT-126, statements regarding AMT's pipeline of product candidates, AMT's Phase 2 clinical trials for AMT-101 including the timing of data readouts from such trials, AMT's ability to leverage its technology to expand its pipeline and Mr. Douglas' potential contributions to AMT. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including those more fully described under the section entitled "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  5. Successfully initiated four planned Phase 2 trials for oral AMT-101 with enrollment ongoing

    Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program, in multiple ulcerative colitis populations and rheumatoid arthritis, beginning in the second half of 2021

    Expanded clinical pipeline with second product candidate, AMT-126, an oral IL-22 fusion biologic therapy for diseases associated with intestinal epithelial barrier defects; Initiated Phase 1a trial in healthy volunteers

    SOUTH SAN FRANCISCO, Calif., March 19, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today provided a corporate…

    Successfully initiated four planned Phase 2 trials for oral AMT-101 with enrollment ongoing

    Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program, in multiple ulcerative colitis populations and rheumatoid arthritis, beginning in the second half of 2021

    Expanded clinical pipeline with second product candidate, AMT-126, an oral IL-22 fusion biologic therapy for diseases associated with intestinal epithelial barrier defects; Initiated Phase 1a trial in healthy volunteers

    SOUTH SAN FRANCISCO, Calif., March 19, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today provided a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2020.

    "We have continued to leverage our proprietary technology platform to rapidly advance our portfolio of transformational oral biologic therapeutics into clinical development," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "Recently, we achieved another significant milestone for the company, initiating our second clinical program, oral AMT-126, in a single ascending dose Phase 1a trial in healthy volunteers. We continue to believe that our most advanced programs, AMT-101 and AMT-126, have broad potential for targeting gastrointestinal-focused, peripheral inflammation and other diseases. Our proprietary technology platform and internal CMC capabilities enable AMT to generate differentiated novel oral biologics and this broad platform continues to generate exciting pipeline opportunities. We look forward to sharing updates on our continued progress across the business."

    Recent Business Highlights and 2020 Accomplishments

    • Initiated four Phase 2 trials for oral AMT-101:
      • LOMBARD monotherapy trial in biologic naïve and experienced patients with moderate-to-severe UC
      • MARKET combination trial of oral AMT-101 with anti-TNFα, in biologic-naïve patients with moderate-to-severe UC
      • FILLMORE monotherapy trial for patients with pouchitis
      • CASTRO combination trial of oral AMT-101 with anti-TNFα for patients with rheumatoid arthritis
    • Expanded clinical pipeline with second program, AMT-126, a GI-selective oral fusion of IL-22 and our proprietary carrier molecule, for diseases associated with intestinal epithelial barrier defects; Initiated Phase 1a trial in healthy volunteers and expect the full Phase 1 development plan to resemble our AMT-101 approach.
    • Successfully manufactured oral AMT-101 and AMT-126 clinical biologic material at AMT's internal GMP manufacturing facility
    • Announced publication of preclinical data demonstrating potential of AMT-101 for inflammatory diseases in The Journal of Immunology
    • Strengthened the executive leadership team with key new hires, including Douglas Rich, chief technical officer, and Earl Douglas, general counsel
    • Closed an underwritten public offering, issuing 12,650,000 shares of common stock at an offering price of $14.00 per share, resulting in gross proceeds of approximately $177.1 million

    Anticipated Upcoming Milestones

    • Top-line data readouts from the four oral AMT-101 Phase 2 trials beginning in 2H 2021 and into 1H 2022
    • Top-line oral AMT-126 Phase 1a/b data in healthy volunteers and patients in 2022

    Financial Results for the Fourth Quarter and Full Year Ended December 31, 2020

    Research and development (R&D) expenses. Total R&D expenses for the year ended December 31, 2020 were $53.9 million, compared to $24.3 million for the year ended December 31, 2019. The increase was primarily due to higher expenses associated with clinical trials, preclinical studies, materials, compensation, contract manufacturing and facilities related expenses.

    General and administrative (G&A) expenses. Total G&A expenses for the year ended December 31, 2020 were $12.7 million, compared to $4.0 million for the year ended December 31, 2019. The increase was primarily due to an increase in personnel costs and professional fees.

    Net loss. Net loss for the year ended December 31, 2020 was $66.6 million, compared to $28.0 million for the year ended December 31, 2019.

    Cash, cash equivalents, and investments. As of December 31, 2020, cash, cash equivalents, and investments were $129.9 million.

    About AMT-101

    AMT-101 is a novel GI-selective, oral fusion of hIL-10 and AMT's proprietary carrier molecule, and is currently being developed in four Phase 2 clinical trials in inflammatory bowel diseases and rheumatoid arthritis. AMT-101 is designed to cross the intestinal epithelium barrier with limited entry into the bloodstream, thereby focusing hIL-10 at the primary site of inflammation for UC and potentially avoiding the side effects observed with systemic administration. By design, AMT-101 is actively transported through the IE barrier into the GI tissue, the primary site of inflammation in UC.

    About AMT-126

    AMT-126 is a novel GI-selective, oral fusion of hIL-22 and AMT's proprietary carrier molecule currently in development for diseases related to intestinal epithelial (IE) barrier defects. IL-22 is a cytokine that repairs structural and functional defects of the IE barrier and induces microbial defense. AMT-126 is designed to act locally on the epithelial cells of the intestinal tissue, thereby repairing the IE barrier and supporting mucosal healing, potentially translating into clinically meaningful improvements in a broad range of GI-focused, peripheral inflammatory and other diseases.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements including statements relating to AMT's plans, expectations, forecasts and future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding AMT's technology platform, statements regarding AMT-101 including the progress of the Phase 2 clinical trials for AMT-101 and the timing of data readouts from such trials, statements regarding AMT-126 including the progress of the Phase 1a/b clinical trial for AMT-126 and the timing of data readouts from such trials, the potential of AMT-101 and AMT-126, AMT's ability to leverage its technology to expand its pipeline, and statements regarding the potential for AMT's products to treat certain medical conditions or diseases. In some cases, you can identify forward-looking statements by terminology such as "estimate," "intend," "may," "plan," "potentially," "will" or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our technology platform to build a pipeline of product candidates; uncertainty of developing biologic therapeutics; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercializing of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; potential delays and disruption resulting from the COVID-19 pandemic; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in AMT's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 19, 2021, and AMT's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Applied Molecular Transport Inc.

    Balance Sheets

    (in thousands, except share and per share amounts)

      As of December 31, 
      2020  2019 
    Assets:        
    Current assets:        
    Cash and cash equivalents $5,843  $12,727 
    Short-term investments  124,026   19,676 
    Prepaid expenses  1,311   532 
    Deferred offering costs     366 
    Other current assets  321   152 
    Total current assets  131,501   33,453 
    Property and equipment, net  8,447   4,091 
    Long-term investments     249 
    Restricted cash  108   108 
    Other assets  127   632 
    Total assets $140,183  $38,533 
    Liabilities, convertible preferred stock and stockholders' equity (deficit):        
    Current liabilities:        
    Accounts payable $3,174  $2,666 
    Accrued expenses  4,173   1,315 
    Deferred rent, current  83   13 
    Capital lease obligations, current  232   42 
    Total current liabilities  7,662   4,036 
    Deferred rent  444   526 
    Capital lease obligations  404   58 
    Total liabilities  8,510   4,620 
    Commitments and contingencies (Note 6)        
    Series A convertible preferred stock, $0.0001 par value, 0 shares authorized, issued and outstanding as of December 31, 2020 and 5,157,213 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 and $33,000 as of December 31, 2020 and 2019, respectively     32,826 
    Series B convertible preferred stock, $0.0001 par value, 0 shares authorized, issued and outstanding as of December 31, 2020 and 3,992,919 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 and $31,025 as of December 31, 2020 and 2019, respectively     30,921 
    Series C convertible preferred stock, $0.0001 par value, 0 shares authorized, issued and outstanding as of December 31, 2020 and 4,816,160 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 and $41,949 as of December 31, 2020 and 2019, respectively     41,868 
    Stockholders' equity (deficit):        
    Common stock, $0.0001 par value, 450,000,000 and 32,000,000 shares authorized as of December 31, 2020 and 2019, respectively; 35,121,360 and 7,360,738 shares issued and outstanding as of December 31, 2020 and 2019, respectively  4   1 
    Additional paid-in capital  271,000   1,078 
    Accumulated other comprehensive income  27   13 
    Accumulated deficit  (139,358)  (72,794)
    Total stockholders' equity (deficit)  131,673   (71,702)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $140,183  $38,533 

    Applied Molecular Transport Inc.

    Statements of Operations and Comprehensive Loss

    (in thousands, except share and per share amounts)

      Year Ended December 31, 
      2020  2019 
    Operating expenses:        
    Research and development $53,936  $24,316 
    General and administrative  12,746   3,974 
    Total operating expenses  66,682   28,290 
    Loss from operations  (66,682)  (28,290)
    Interest income, net  229   273 
    Other expense, net  (111)  (26)
    Net loss $(66,564) $(28,043)
    Net loss per share, basic and diluted $(2.91) $(3.81)
    Weighted-average shares of common stock outstanding, basic and diluted  22,878,325   7,360,738 
    Comprehensive loss:        
    Net loss $(66,564) $(28,043)
    Other comprehensive income (loss):        
    Net unrealized gains on investments  33  13 
    Amounts recognized for net realized gain included in net loss  (19)   
    Total comprehensive loss $(66,550) $(28,030)

    Refer to the Company's applicable filings with the SEC for additional disclosures including our Annual Report on Form 10-K for fiscal year 2020.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors

     



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  6. SOUTH SAN FRANCISCO, Calif., March 09, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder, will participate in a fireside chat during the Oppenheimer 31st Annual Healthcare Conference on Thursday, March 18, 2021 at 11:20 a.m. ET.

    A live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology…

    SOUTH SAN FRANCISCO, Calif., March 09, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder, will participate in a fireside chat during the Oppenheimer 31st Annual Healthcare Conference on Thursday, March 18, 2021 at 11:20 a.m. ET.

    A live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  7. Company expands pipeline with second clinical program, AMT-126, an oral IL-22 fusion biologic therapy for diseases associated with intestinal epithelial barrier defects

    IL-22 deficiency implicated in broad range of gastrointestinal-focused and peripheral diseases ranging from ulcerative colitis to multiple rheumatologic disorders

    Complete oral AMT-126 Phase 1a/b data in healthy volunteers and patients anticipated in 2022

    Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program beginning in the second half of 2021

    SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical…

    Company expands pipeline with second clinical program, AMT-126, an oral IL-22 fusion biologic therapy for diseases associated with intestinal epithelial barrier defects

    IL-22 deficiency implicated in broad range of gastrointestinal-focused and peripheral diseases ranging from ulcerative colitis to multiple rheumatologic disorders

    Complete oral AMT-126 Phase 1a/b data in healthy volunteers and patients anticipated in 2022

    Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program beginning in the second half of 2021

    SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced the first in human dosing in its Phase 1a clinical trial of oral AMT-126. The randomized, placebo controlled, single ascending dose Phase 1a trial is evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of AMT-126, a novel, gastrointestinal (GI)-selective oral fusion of human interleukin-22 (hIL-22), in up to 50 healthy volunteers.

    "We have rapidly advanced into the clinic our second novel program leveraging our platform technology to create a pipeline of transformational oral biologic therapeutics with unique and differentiated profiles," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "Based on our important preclinical findings to date and similar to our lead program, AMT-101, an oral IL-10 fusion biologic therapy, AMT-126 has the potential to be another pipeline in a product for the company targeting both GI-focused and peripheral diseases. Advancing AMT-126 into the clinic further validates AMT's broad oral biologics technology platform and we look forward to generating additional pipeline products to address diseases with significant unmet needs. In addition to this recent progress with AMT-126, the company remains on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials from its comprehensive clinical program beginning in the second half of this year."

    "Following this Phase 1a single ascending dose trial, we intend to advance AMT-126 into a Phase 1b trial in patients who have gastrointestinal barrier dysfunction and expect the full Phase 1 development plan to resemble our AMT-101 approach," said Bittoo Kanwar, M.D., chief medical officer of AMT. "Given the well-established role of IL-22 to promote a healthy epithelial barrier and regulate inflammation, we see enormous potential for AMT-126 to address both gastrointestinal disease and peripheral disease secondary to GI dysfunction. Because AMT-126 is designed to be gut selective, we believe it may have an improved safety profile when compared to systemically administered IL-22."

    About AMT-126

    AMT-126 is a novel GI-selective, oral fusion of hIL-22 and AMT's proprietary carrier molecule currently in development for diseases related to intestinal epithelial (IE) barrier defects. IL-22 is a cytokine that repairs structural and functional defects of the IE barrier and induces microbial defense. AMT-126 is designed to act locally on the epithelial cells of the intestinal tissue, thereby repairing the IE barrier and supporting mucosal healing.

    About AMT-101

    AMT-101 is a novel GI-selective, oral fusion of hIL-10 and AMT's proprietary carrier molecule, which is currently being developed in four Phase 2 clinical trials in inflammatory bowel diseases and rheumatoid arthritis. AMT-101 is designed to cross the intestinal epithelium barrier with limited entry into the bloodstream, thereby focusing hIL-10 at the primary site of inflammation for UC and, potentially avoiding the side effects observed with systemic administration. By design, AMT-101 is actively transported through the IE barrier into the GI tissue, the primary site of inflammation in UC.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or AMT's future plans, strategy and performance. Such statements include, but are not limited to, the potential of, and expectations regarding the potential of, potential benefits of, and expectations regarding AMT's technology platform and AMT-101 and AMT-126, statements regarding AMT's Phase 2 clinical trials for AMT-101 including the timing of such trials, expectations relating to data readouts from the Phase 2 clinical trials, AMT's ability to leverage its technology to expand its pipeline and the timing of receipt of AMT-126 Phase 1a/b data. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including those more fully described under the section entitled "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  8. SOUTH SAN FRANCISCO, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder, will participate in a fireside chat during the SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 4:20 p.m. ET.

    A live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.
    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its…

    SOUTH SAN FRANCISCO, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder, will participate in a fireside chat during the SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 4:20 p.m. ET.

    A live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors

     



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  9. SOUTH SAN FRANCISCO, Calif., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that it has appointed Douglas Rich as Chief Technical Officer. In his new role, Douglas will assume leadership responsibilities for all process development, manufacturing, CMC and formulation activities, including quality and supply chain responsibilities. He will become a member of the AMT Executive Team, reporting to chief executive officer and co-founder of AMT, Tahir Mahmood, Ph.D.

    "We continue to recognize the criticality of furthering our internal GMP manufacturing and formulation development for the company's long-term success," stated Tahir Mahmood, Ph.D…

    SOUTH SAN FRANCISCO, Calif., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that it has appointed Douglas Rich as Chief Technical Officer. In his new role, Douglas will assume leadership responsibilities for all process development, manufacturing, CMC and formulation activities, including quality and supply chain responsibilities. He will become a member of the AMT Executive Team, reporting to chief executive officer and co-founder of AMT, Tahir Mahmood, Ph.D.

    "We continue to recognize the criticality of furthering our internal GMP manufacturing and formulation development for the company's long-term success," stated Tahir Mahmood, Ph.D. "Doug's significant experience in technical operations and quality, and track record of building and leading high caliber teams, will serve as foundational components of our growth strategy. Last month, we initiated our second and third Phase 2 trials for oral AMT-101, FILLMORE for patients with pouchitis and CASTRO with oral AMT-101 in combination with approved anti-TNFα therapy for patients with rheumatoid arthritis. With continued progress in the clinic and across the business, I look forward to Doug's important contributions as we advance our promising pipeline of novel, oral biologic medicines."

    With more than 26 years of experience in the biopharma industry, Mr. Rich brings deep operations and quality experience across the entire product lifecycle. He has served in leadership roles responsible for the development and commercialization of both biopharmaceuticals and small molecules. Mr. Rich most recently served as Senior Vice President, Operations at UNITY Biotechnology where he led Technical Operations, Quality, Supply Chain, and Portfolio/Project/Alliance Management. Prior to UNITY, he was Senior Vice President, Operations at Kythera Biopharmaceuticals, acquired by Allergan plc. Prior to Kythera, he was Vice President, Quality at Boehringer-Ingelheim where he worked in both the Biopharmaceutical and Prescription Medicine Business Units. Earlier in his career, Mr. Rich also spent over 18 years at Amgen, in various roles within Operations including Global Operations Strategy, Manufacturing, Quality Control, and Site Quality Head.

    "I am extremely excited about joining the company at such an important time," said Douglas Rich, chief technical officer of AMT. "It is critical to continue to build on the vision propelled by our technology platform and internal GMP manufacturing, product formulation and other technical capabilities to expand and advance our deep pipeline of promising oral biologic products."

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or AMT's future plans, strategy and performance. Such statements include, but are not limited to, the potential of, and expectations regarding AMT's technology platform and AMT-101, statements regarding AMT's Phase 2 clinical trials for AMT-101 including the timing of such trials and the dosing related to such trials, AMT's ability to leverage its technology to expand its pipeline and Mr. Doug Rich's potential contributions to AMT. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including those more fully described under the section entitled "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  10. SOUTH SAN FRANCISCO, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder, will participate in a fireside chat during the Evercore ISI 3rd Annual HealthCONx Conference on Tuesday, December 1, 2020 at 3:30 p.m. ET.

    A live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary…

    SOUTH SAN FRANCISCO, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder, will participate in a fireside chat during the Evercore ISI 3rd Annual HealthCONx Conference on Tuesday, December 1, 2020 at 3:30 p.m. ET.

    A live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly tablet and capsule forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors



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  11. - Company on track with comprehensive AMT-101 Phase 2 clinical program across multiple indications, including inflammatory bowel diseases and rheumatoid arthritis -

    - Announced dosing of first patient in Phase 2 monotherapy trial (LOMBARD) evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severe ulcerative colitis -

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2020.

    "We continue to make important progress in the development of our differentiated oral biologic drug candidates in a number of indications," said Tahir Mahmood…

    - Company on track with comprehensive AMT-101 Phase 2 clinical program across multiple indications, including inflammatory bowel diseases and rheumatoid arthritis -

    - Announced dosing of first patient in Phase 2 monotherapy trial (LOMBARD) evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severe ulcerative colitis -

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter ended September 30, 2020.

    "We continue to make important progress in the development of our differentiated oral biologic drug candidates in a number of indications," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "We recently advanced oral AMT-101 into a Phase 2 monotherapy trial in patients with ulcerative colitis (UC). In addition, we continue the planned expansion of this comprehensive clinical program with two additional Phase 2 trials of AMT-101 in combination with anti-TNFα therapy in biologic-naïve patients with moderate to severe UC and as a monotherapy in patients with pouchitis, both initiating by year-end. We are also looking forward to the initiation of the fourth Phase 2 trial for AMT-101 in combination with anti-TNFα in rheumatoid arthritis patients who are partially responding to anti-TNFα therapy. Furthermore, given the broad potential of our technology platform as an engine for the development of novel oral biologics, we continue to work on expanding our deep pipeline into additional indications and therapeutic areas and look forward to sharing updates on our progress."

    Recent Business Highlights

    • Announced dosing of the first patient in the LOMBARD Phase 2 monotherapy trial evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severe UC
    • Successfully manufactured AMT-101 and AMT-126 clinical biologic drug supply at AMT's internal GMP manufacturing facility
    • Announced publication of preclinical data demonstrating potential of AMT-101 for inflammatory diseases in The Journal of Immunology (November 2020 issue)

    Anticipated Upcoming Milestones

    • Initiate the remaining Phase 2 trials for oral AMT-101:
      • MARKET clinical trial of oral AMT-101 in combination with anti-TNFα, in biologic-naïve, moderate to severe UC patients by year-end
      • FILLMORE clinical trial of oral AMT-101 for the treatment of pouchitis by year-end
      • CASTRO clinical trial of oral AMT-101 in combination with anti-TNFα for the treatment of rheumatoid arthritis in 1H 2021
      • Anticipate top-line data readouts from the four AMT-101 Phase 2 trials beginning in 2H 2021 and into 1H 2022
    • File IND/CTA for AMT-126, a gastrointestinal (GI)-selective oral fusion of hIL-22, to treat serious diseases associated with intestinal epithelial (IE) barrier defects by year-end

    Financial Results for the Third Quarter Ended September 30, 2020

    Research and development (R&D) expenses. Total R&D expenses for the third quarter of 2020 were $13.4 million, compared to $6.9 million for the same period in 2019. The increase was primarily due to higher expenses associated with clinical trials, preclinical studies, materials, compensation, and facilities related expenses, offset by a decrease in contract manufacturing due to internal capabilities.

    General and administrative (G&A) expenses. Total G&A expenses for the third quarter of 2020 were $3.4 million, compared to $1.0 million for the same period in 2019. The increase was primarily due to an increase in personnel costs and professional fees.

    Net loss. Net loss for the third quarter of 2020 was $16.8 million, compared to $7.9 million for the third quarter of 2019.

    Cash, cash equivalents, and investments. As of September 30, 2020, cash, cash equivalents, and investments were $147.3 million.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the IE barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly tablet and capsule forms that are designed to either target local GI tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements including statements relating to AMT's plans, expectations, forecasts and future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding AMT's technology platform, statements regarding AMT's Phase 2 clinical trials for AMT-101 including the timing of such trials, the timing of the filing of IND/CTA for AMT-126, AMT's ability to leverage its technology to expand its pipeline, presentations regarding AMT-101's Phase 1b dataset, and AMT-101 top-line data readouts including the timing of such readouts. In some cases, you can identify forward-looking statements by terminology such as "estimate," "intend," "may," "plan," "potentially," "will" or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our technology platform to build a pipeline of product candidates; uncertainty of developing biologic therapeutics; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercializing of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; potential delays and disruption resulting from the COVID-19 pandemic; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in AMT's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 12, 2020, and AMT's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.



    Applied Molecular Transport Inc.

    Condensed Balance Sheets

    (unaudited)

    (in thousands, except share and per share amounts)

      September 30,  December 31, 
      2020  2019(*) 
    Assets        
    Current assets:        
    Cash and cash equivalents $11,314  $12,727 
    Short-term investments  135,940   19,676 
    Prepaid expenses  1,816   532 
    Deferred offering costs     366 
    Other current assets  79   152 
    Total current assets  149,149   33,453 
    Property and equipment, net  8,437   4,091 
    Long-term investments     249 
    Restricted cash  108   108 
    Other assets  127   632 
    Total assets $157,821  $38,533 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)        
    Current liabilities:        
    Accounts payable $2,705  $2,666 
    Accrued expenses  4,692   1,315 
    Deferred rent, current  65   13 
    Capital lease obligations, current  229   42 
    Total current liabilities  7,691   4,036 
    Deferred rent  473   526 
    Capital lease obligations  463   58 
    Total liabilities  8,627   4,620 
    Commitments and contingencies        
    Series A convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 5,157,213 shares authorized, issued and outstanding, as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $33,000 as of December 31, 2019     32,826 
    Series B convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 3,992,919 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $31,025 as of December 31, 2019     30,921 
    Series C convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of September 30, 2020 and 4,816,160 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 as of September 30, 2020 and $41,949 as of December 31, 2019     41,868 
    Stockholders' equity (deficit):        
    Common stock, $0.0001 par value, 450,000,000 and 32,000,000 shares authorized as of September 30, 2020, and December 31, 2019, respectively; 34,880,411 and 7,360,738 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively  3   1 
    Additional paid-in capital  269,437   1,078 
    Accumulated other comprehensive income  31   13 
    Accumulated deficit  (120,277)  (72,794)
    Total stockholders' equity (deficit)  149,194   (71,702)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $157,821  $38,533 

    (*)    Derived from audited Financial Statements.



    Applied Molecular Transport Inc.

    Condensed Statements of Operations and Comprehensive Loss

    (unaudited)

    (in thousands, except share and per share amounts)

      Three Months Ended  Nine Months Ended 
      September 30,  September 30, 
      2020  2019  2020  2019 
    Operating expenses:                
    Research and development $13,395  $6,890  $39,185  $17,756 
    General and administrative  3,428   1,008   8,404   2,510 
    Total operating expenses  16,823   7,898   47,589   20,266 
    Loss from operations  (16,823)  (7,898)  (47,589)  (20,266)
    Interest income, net  59   36   187   107 
    Other expense, net  (29)  (3)  (81)  (15)
    Net loss $(16,793) $(7,865) $(47,483) $(20,174)
    Net loss per share, basic and diluted $(0.48) $(1.07) $(2.53) $(2.74)
    Weighted-average shares of common stock outstanding, basic and diluted  34,767,308   7,360,738   18,770,153   7,360,738 
    Comprehensive loss:                
    Net loss $(16,793) $(7,865) $(47,483) $(20,174)
    Other comprehensive income (loss):                
    Unrealized gains on investments  29   3   37   3 
    Amounts recognized for net realized gains included in net loss        (19)   
    Total comprehensive loss $(16,764) $(7,862) $(47,465) $(20,171)

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors

     

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  12. SOUTH SAN FRANCISCO, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT, and Bittoo Kanwar, M.D., chief medical officer of AMT, will participate in a fireside chat during the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 12:00 p.m. ET / 5:00 p.m. GMT.

    A live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.
    Applied Molecular Transport Inc. is…

    SOUTH SAN FRANCISCO, Calif., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT, and Bittoo Kanwar, M.D., chief medical officer of AMT, will participate in a fireside chat during the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 12:00 p.m. ET / 5:00 p.m. GMT.

    A live webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly tablet and capsule forms that are designed to either target local gastrointestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Alexandra Santos

    Wheelhouse Life Science Advisors

    Aljanae Reynolds

    Wheelhouse Life Science Advisors

    Primary Logo

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  13. - AMT-101 (oral fusion protein of hIL-10 and AMT carrier) rapidly and efficiently transports through intestinal epithelia in healthy and inflamed conditions to target local intestinal tissue -

    - Demonstrates minimal systemic exposure of hIL-10 while driving induction of an anti-inflammatory profile correlated with hIL-10 in rodent and non-human primate models -

    - Acts on macrophage cells and lymphocytes within intestinal tissue leading to efficacy outcomes in colitis models -

    SOUTH SAN FRANCISCO, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that the unique mechanism of action of AMT-101 and preclinical data supporting its potential…

    - AMT-101 (oral fusion protein of hIL-10 and AMT carrier) rapidly and efficiently transports through intestinal epithelia in healthy and inflamed conditions to target local intestinal tissue -

    - Demonstrates minimal systemic exposure of hIL-10 while driving induction of an anti-inflammatory profile correlated with hIL-10 in rodent and non-human primate models -

    - Acts on macrophage cells and lymphocytes within intestinal tissue leading to efficacy outcomes in colitis models -

    SOUTH SAN FRANCISCO, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that the unique mechanism of action of AMT-101 and preclinical data supporting its potential as a treatment for ulcerative colitis (UC), and other inflammatory diseases, have been published in The Journal of Immunology. The article entitled, "A Novel Fusion of Interleukin-10 Engineered to Traffic Across Intestinal Epithelium to Treat Colitis" was published in the November 2020 online edition of The Journal of Immunology.

    The research published in The Journal of Immunology highlights how AMT's proprietary technology platform exploits existing natural cellular trafficking pathways to actively transport therapeutics through the intestinal barrier directly into the underlying immune-rich milieu of the lamina propria. IL-10 is a potent immunomodulatory cytokine with significant therapeutic potential in intestinal inflammatory diseases as well as in those associated with systemic inflammation. However, clinical utilization of IL-10 to treat inflammation and immune-dysregulation has been limited due to side effects associated with systemic administration.

    "Our breakthrough platform technology enables the active transport of oral biologics by solving the long-standing industry challenge of transporting large, biologically-active molecules efficiently across the intestinal barrier," said Randall Mrsny, Ph.D., chief scientific officer and co-founder of AMT. "Our technology platform is based on native, active vesicular transcytosis mechanisms to rapidly and efficiently traverse intestinal epithelial cells. Once across this epithelia barrier and in the underlying intestinal lamina propria, AMT-101 targets local macrophages and lymphocytes to activate cell signaling pathways, inducing tissue and circulating markers demonstrating IL-10 mechanism of action through cognate receptor engagement and down-stream signaling. Importantly, we continue to leverage our technology platform to be a robust engine for the design and development of a wide range of oral biologic therapeutics."

    In vitro and in vivo characterization of AMT-101 demonstrated its ability to efficiently cross the human intestinal epithelium by an active, receptor-mediated vesicular transcytosis process, activating IL-10 receptor signaling to increase cellular phospho-STAT3 (pSTAT3) levels in macrophage cells. In models of induced colitis, AMT-101 was able to rectify pathologic changes by suppressing pro-inflammatory markers of disease while inducing anti-inflammatory cytokines, both locally in the intestinal tissue as well as in plasma.

    "Our preclinical data has also shown that oral hIL-10 can be targeted to the intestinal lamina propria with minimal systemic PK, suggesting that we may be able treat IBD patients with fewer toxicities than previously observed following the systemic administration of this potent cytokine," said Tahir Mahmood, PhD, chief executive officer and co-founder of AMT. "We have evaluated AMT-101 in active ulcerative colitis patients in a Phase 1b study and demonstrated reductions in objective clinical measures of intestinal inflammation such as fecal calprotectin and histopathologic scores, as well as systemic indicators of inflammation such as C-reactive protein, after just 14 days of treatment. We are excited about our ongoing and planned Phase 2 trials for AMT-101 in IBD and rheumatoid arthritis and will continue to leverage the platform to build our pipeline of differentiated oral biologic therapeutics."

    About AMT-101

    AMT-101 is a GI-selective, oral fusion of hIL-10 and its proprietary carrier molecule, which is currently being developed in four Phase 2 clinical trials in inflammatory bowel diseases and rheumatoid arthritis. AMT-101 is designed to cross the intestinal epithelium (IE) barrier with limited entry into the bloodstream, thereby focusing hIL-10 in the lamina propria of the gastrointestinal (GI) tissue and, therefore, potentially avoiding the side effects observed with systemic administration. By design, AMT-101 is actively transported through the IE barrier into the GI tissue, the primary site of inflammation in UC.

    About Ulcerative Colitis

    Ulcerative colitis (UC) is an inflammatory autoimmune disease of the GI tract with approximately 2.2 to 2.4 million patients in the United States and Europe according to a 2014 report. Current therapies for UC have significant adverse side effects including systemic immunosuppression, increased incidence of opportunistic and rare infections, and increased risk for cancer. Furthermore, approximately half of UC patients will relapse in any given year, including a minority with frequently relapsing or chronic, continuous disease and approximately 15.6% of UC patients will undergo surgery within 10 years of diagnosis, with 20% to 30% of patients ultimately proceeding to surgical colectomy. In addition, UC may have a profound effect on quality of life, including mental health consequences, and a significant minority of patients become incapable of work due to disease. Thus, there remains a significant and unmet clinical need to better manage UC with safer and more effective oral therapies.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the IE barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly tablet and capsule forms that are designed to either target local GI tissue or enter systemic circulation to precisely address the relevant biology of a disease.

    AMT's headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or AMT's future plans, strategy and performance. Such statements include, but are not limited to, the potential of, and expectations regarding AMT's technology platform and AMT-101, statements regarding AMT's Phase 2 clinical trials for AMT-101 including the timing of such trials, AMT's ability to leverage its technology to expand its pipeline, and the unmet clinical need to better manage UC. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including those more fully described under the section entitled "Risk Factors" in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Investor Relations Contact:

    Andrew Chang

    Head, Investor Relations & Corporate Communications

    Media Contacts:

    Sylvia Wheeler

    Principal, Wheelhouse Life Science Advisors

    Alexandra Santos

    Senior Partner, Wheelhouse Life Science Advisors

    Primary Logo

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  14. SOUTH SAN FRANCISCO, Calif., Sept. 22, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT, and Bittoo Kanwar, M.D., chief medical officer of AMT, will participate in a fireside chat during the Jefferies Next Generation IBD Therapeutics Virtual Summit which will be webcasted on Wednesday, September 23, 2020 at 8:00 a.m. ET.

    The webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.
    Applied Molecular…

    SOUTH SAN FRANCISCO, Calif., Sept. 22, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT, and Bittoo Kanwar, M.D., chief medical officer of AMT, will participate in a fireside chat during the Jefferies Next Generation IBD Therapeutics Virtual Summit which will be webcasted on Wednesday, September 23, 2020 at 8:00 a.m. ET.

    The webcast will be accessible via the Events page of the Applied Molecular Transport website at https://ir.appliedmt.com/news-events/events. An archived replay will be available for 30 days following the event.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing oral biologic product candidates in patient-friendly tablet and capsule forms that are designed for either targeting local gastrointestinal (GI) tissue or entering systemic circulation to precisely address the relevant biology of a disease. AMT is building a portfolio of oral product candidates based on its technology platform including its lead product candidate, AMT-101, an oral GI-selective interleukin 10 that has completed a Phase 1b clinical trial in patients with ulcerative colitis (UC). AMT further plans to initiate Phase 2 clinical trials of AMT-101 in UC and related inflammatory indications. AMT's technology platform enables it to design and develop various oral biologic therapeutic modalities, such as peptides, proteins, full-length antibodies, antibody fragments, and RNA therapeutics, with potentially significant advantages over existing marketed and development-stage drugs.

    Contacts:

    Sylvia Wheeler

    Principal, Wheelhouse Life Science Advisors

    Alexandra Santos

    Senior Partner, Wheelhouse Life Science Advisors

    Primary Logo

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  15. SOUTH SAN FRANCISCO, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a randomized, placebo-controlled, double-blind, multicenter Phase 2a study evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severely active ulcerative colitis (UC). AMT-101 is a gut-selective, oral, once-daily, biologic fusion protein of interleukin 10 (IL-10) which utilizes the company's proprietary platform technology to harness the power of natural active transport mechanisms for a potentially more efficacious and safer biologic therapeutic.

    "We are pleased with the speed at which we have launched…

    SOUTH SAN FRANCISCO, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a randomized, placebo-controlled, double-blind, multicenter Phase 2a study evaluating the efficacy and safety of oral AMT-101 in patients with moderate to severely active ulcerative colitis (UC). AMT-101 is a gut-selective, oral, once-daily, biologic fusion protein of interleukin 10 (IL-10) which utilizes the company's proprietary platform technology to harness the power of natural active transport mechanisms for a potentially more efficacious and safer biologic therapeutic.

    "We are pleased with the speed at which we have launched this first Phase 2 clinical trial for AMT 101 in biologic-naïve and treatment-experienced UC patients, one trial in four that we have planned to evaluate the broad clinical potential of our lead drug candidate," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "AMT-101 is unique in that it is designed to provide the immunomodulatory activity of IL-10 directly at the site of active disease in the gastrointestinal tract with minimal drug levels in the blood, lowering the risk of systemic side effects. Beyond UC, AMT-101 has the potential to be a promising treatment in other indications including systemic inflammatory diseases, and we plan on initiating three additional Phase 2 studies to further characterize its therapeutic potential."

    The Phase 2a study will include approximately 100 adult patients with moderate to severely active UC who will be randomized 2:1 to either receive oral AMT-101 or placebo for 12 weeks of treatment. The global study will enroll both biologic-experienced and naïve patients in approximately 20 countries. The primary endpoint of the study is to assess the efficacy of repeat oral doses of AMT-101 versus placebo in reducing components of the Mayo Score at week 12. Secondary endpoints include safety, pharmacokinetics (PK), health-related quality of life, and markers of disease activity as measured by symptoms, endoscopy, histology, and biomarkers. Exploratory objectives include assessments of the pharmacodynamic (PD) effect on inflammation and biomarkers, as well as PK parameters in mucosal tissue.

    "UC remains a very challenging condition to treat with current therapies unable to resolve the disease in many patients. In our successful Phase 1b study, we demonstrated that oral doses of AMT-101 were safe and improved objective disease markers in patients with UC after just two weeks of treatment," said Bittoo Kanwar, M.D., chief medical officer of AMT. "As an oral, gut-selective immunomodulatory biologic therapy, AMT-101 could significantly improve the lives of patients with UC."

    About AMT-101

    AMT-101 is a GI-selective, oral fusion of rhIL-10 and its proprietary carrier molecule, which has been evaluated in a Phase 1b trial in ulcerative colitis (UC). AMT-101 is designed to cross the intestinal epithelium (IE) barrier while not entering the bloodstream, thereby focusing the drug directly at the site of action of the underlying biology of the disease in the gastrointestinal (GI) tissue and, therefore, potentially avoiding the side effects observed with systemic administration. By design, AMT-101 is actively transported through the IE barrier into the GI tissue, the primary site of inflammation in UC, a disease with approximately 2.2 to 2.4 million patients in the United States and Europe according to a 2014 report. As a locally-targeted, GI-selective biologic therapeutic, AMT-101 has potential use in a variety of inflammatory indications beyond UC.

    About Ulcerative Colitis

    Ulcerative colitis (UC) is an inflammatory autoimmune disease of the gastrointestinal (GI) tract that manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. As a result, the precise etiology for disease initiation differs widely among patients with UC. Current therapies for UC have significant adverse side effects including systemic immunosuppression, increased incidence of opportunistic and rare infections, and increased risk for cancer. Furthermore, approximately half of UC patients will relapse in any given year, including a minority with frequently relapsing or chronic, continuous disease. Approximately 15.6% of UC patients will undergo surgery within 10 years of diagnosis, with 20% to 30% of patients ultimately proceeding to surgical colectomy. In addition, UC may have a profound effect on quality of life, including mental health consequences, and a significant minority become incapable of work due to disease. Thus, there remains a significant and unmet clinical need to better manage UC with safer and more effective oral therapies.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing oral biologic product candidates in patient-friendly tablet and capsule forms that are designed for either targeting local gastrointestinal (GI) tissue or entering systemic circulation to precisely address the relevant biology of a disease. AMT is building a portfolio of oral product candidates based on its technology platform including its lead product candidate, AMT-101, an oral GI-selective interleukin 10 that has completed a Phase 1b clinical trial in patients with ulcerative colitis (UC). AMT further plans to initiate Phase 2 clinical trials of AMT-101 in UC and related inflammatory indications. AMT's technology platform enables it to design and develop various oral biologic therapeutic modalities, such as peptides, proteins, full-length antibodies, antibody fragments, and RNA therapeutics, with potentially significant advantages over existing marketed and development-stage drugs.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or AMT's future plans, strategy and performance. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including those more fully described under the section entitled "Risk Factors" in AMT's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 11, 2020, and AMT's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

    Contacts:

    Sylvia Wheeler

    Principal, Wheelhouse Life Science Advisors

    Alexandra Santos

    Senior Partner, Wheelhouse Life Science Advisors

    Primary Logo

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  16.  -Company debuts with successful $177 million IPO
     -Plans to initiate three Phase 2 clinical trials for AMT-101 in 2020; anticipates top-line data readouts in 2H 2021 and 1H 2022
     -On track to file IND/CTA by year-end 2020 for AMT-126, AMT's second therapeutic product candidate

    SOUTH SAN FRANCISCO, Calif., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI), a clinical-stage biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2020.

    "As we expected, 2020 has been a transformational year with the successful execution of our initial public offering, the appointment of key executives, the generation of important clinical data for our lead product candidate AMT-101, and the advancement…

     -Company debuts with successful $177 million IPO
     -Plans to initiate three Phase 2 clinical trials for AMT-101 in 2020; anticipates top-line data readouts in 2H 2021 and 1H 2022
     -On track to file IND/CTA by year-end 2020 for AMT-126, AMT's second therapeutic product candidate

    SOUTH SAN FRANCISCO, Calif., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI), a clinical-stage biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2020.

    "As we expected, 2020 has been a transformational year with the successful execution of our initial public offering, the appointment of key executives, the generation of important clinical data for our lead product candidate AMT-101, and the advancement of AMT-101 into a comprehensive Phase 2 clinical program during the second half of this year," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "The AMT-101 Phase 1a/b clinical data are a compelling validation of our technology platform as an engine for developing differentiated oral biologics product candidates including peptides, proteins, antibodies and RNA therapeutics."

    Recent Business Highlights

     Completed a successful initial public offering with gross proceeds of $177 million
     Appointed experienced executives to build out AMT's leadership team across key functions, including clinical development, finance, business development and strategy, and manufacturing
     Presented preclinical data on AMT-101 (an oral gastrointestinal tissue-targeted biologic rhIL-10 fusion) in a plenary session at the European Crohn's and Colitis Organisation (ECCO) annual meeting demonstrating activity and efficacy of AMT-101 in an ulcerative colitis (UC) model, offering potentially improved efficacy and safety compared to systemically administered rhIL-10
     Completed a successful Phase 1a/b clinical trial for oral AMT-101 in healthy volunteers and UC patients
       UC patients with active inflammation treated with AMT-101 showed trends of improvement in objective disease markers such as fecal calprotectin and histopathologic scores after only 14 days of treatment
       AMT-101 was well tolerated in both healthy volunteers and UC patients
     Activated AMT's internal GMP biologics manufacturing facility
     Selected as one of three finalists for the Fierce Innovations Award for AMT-101

    Anticipated Upcoming Catalysts

     Advancing oral AMT-101 into a comprehensive Phase 2 clinical program including biologic-naïve and treatment-experienced UC patients, in combination with anti-TNFα therapy in UC, and in patients with pouchitis in 2020; and an additional combination study with anti-TNFα therapy in patients with rheumatoid arthritis is planned for 2021
     On track to submit an IND/CTA for AMT-126, a GI-selective oral fusion of rhIL-22, by year-end 2020 for diseases related to intestinal epithelium barrier defects driven by activation of the innate immune system

    Financial Results for the Second Quarter Ended June 30, 2020

    Research and development (R&D) expenses. Total R&D expenses for the second quarter of 2020 were $12.8 million, compared to $6.5 million for the same period in 2019. The increase was primarily due to higher expenses associated with clinical trials, compensation, contract manufacturing and facilities related expenses, offset by a decrease in other research and development activities.

    General and administrative (G&A) expenses. Total G&A expenses for the second quarter of 2020 were $2.5 million, compared to $0.9 million for the same period in 2019. The increase was primarily due to an increase in personnel costs and professional fees.

    Net loss. Net loss for the second quarter of 2020 was $15.4 million, compared to $7.3 million for the second quarter of 2019.

    Cash, cash equivalents, and investments. As of June 30, 2020, cash, cash equivalents, and investments were $163.3 million, compared to $32.7 million as of December 31, 2019. The increase was primarily driven by the company's initial public offering in June of this year.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of therapeutic payloads across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing oral biologic product candidates in patient-friendly tablet and capsule forms that are designed for either targeting local gastrointestinal (GI) tissue or entering systemic circulation to precisely address the relevant biology of a disease. AMT is building a portfolio of oral product candidates based on its technology platform including its lead product candidate, AMT-101, an oral GI-selective interleukin 10 that has completed a Phase 1b clinical trial in patients with ulcerative colitis (UC). AMT further plans to initiate Phase 2 clinical trials of AMT-101 in UC and related inflammatory indications. AMT's technology platform enables it to design and develop various oral biologic therapeutic modalities, such as peptides, proteins, full-length antibodies, antibody fragments, and RNA therapeutics, with potentially significant advantages over existing marketed and development-stage drugs.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "estimate," "intend," "may," "plan," "potentially" "will" or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our technology platform to build a pipeline of product candidates; uncertainty of developing biologic therapeutics;  our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercializing of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in AMT's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 11, 2020, and AMT's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

     
    Applied Molecular Transport Inc.
    Condensed Balance Sheets
    (unaudited)
    (in thousands, except share and per share amounts)
          
     June 30,  December 31, 
     2020  2019(*) 
    Assets       
    Current assets:       
    Cash and cash equivalents$23,401  $12,727 
    Short-term investments 139,862   19,676 
    Prepaid expenses 1,764   532 
    Deferred offering costs    366 
    Other current assets 611   152 
    Total current assets 165,638   33,453 
    Property and equipment, net 6,786   4,091 
    Long-term investments    249 
    Restricted cash 108   108 
    Other assets 128   632 
    Total assets$172,660  $38,533 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)       
    Current liabilities:       
    Accounts payable$4,437  $2,666 
    Accrued expenses 2,288   1,315 
    Deferred rent, current 48   13 
    Other current liabilities 97   42 
    Total current liabilities 6,870   4,036 
    Deferred rent 496   526 
    Other liabilities 185   58 
    Total liabilities 7,551   4,620 
    Commitments and contingencies (Note 6)       
    Series A convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of June 30, 2020 and 5,157,213 shares authorized, issued and outstanding, as of December 31, 2019; liquidation value of $0 as of June 30, 2020 and $33,000 as of December 31, 2019    32,826 
    Series B convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of June 30, 2020 and 3,992,919 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 as of June 30, 2020 and $31,025 as of December 31, 2019    30,921 
    Series C convertible preferred stock, $0.0001 par value, 0 shares authorized, issued, and outstanding as of June 30, 2020 and 4,816,160 shares authorized, issued and outstanding as of December 31, 2019; liquidation value of $0 as of June 30, 2020 and $41,949 as of December 31, 2019    41,868 
    Stockholders' equity (deficit):       
    Common stock, $0.0001 par value, 450,000,000 shares authorized as of June 30, 2020 and 32,000,000 shares authorized as of December 31, 2019; 34,050,624 and 7,360,738 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively 3   1 
    Additional paid-in capital 268,588   1,078 
    Accumulated other comprehensive income 2   13 
    Accumulated deficit (103,484)  (72,794)
    Total stockholders' equity (deficit) 165,109   (71,702)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit)$172,660  $38,533 

    __________________

    (*)       Derived from audited Financial Statements.

     
    Applied Molecular Transport Inc.
    Condensed Statements of Operations and Comprehensive Loss
    (unaudited)
    (in thousands, except share and per share amounts)
          
     Three Months Ended  Six Months Ended 
     June 30,  June 30, 
     2020  2019  2020  2019 
    Operating expenses:               
    Research and development$12,836  $6,500  $25,790  $10,866 
    General and administrative 2,487   867   4,976   1,502 
    Total operating expenses 15,323   7,367   30,766   12,368 
    Loss from operations (15,323)  (7,367)  (30,766)  (12,368)
    Interest income 48   58   131   59 
    Other expense, net (104)     (55)   
    Net loss$(15,379) $(7,309) $(30,690) $(12,309)
    Net loss per share, basic and diluted$(1.11) $(0.99) $(2.88) $(1.67)
    Weighted-average shares of common stock outstanding, basic and diluted 13,869,040   7,360,738   10,643,240   7,360,738 
    Comprehensive loss:               
    Net loss$(15,379) $(7,309) $(30,690) $(12,309)
    Other comprehensive income (loss):               
    Unrealized gains on investments 2      8    
    Amounts recognized for net realized gains included in net loss (19)     (19)   
    Total comprehensive loss$(15,396) $(7,309) $(30,701) $(12,309)
     

    Contacts:

    Sylvia Wheeler

    Principal, Wheelhouse Life Science Advisors

    Alexandra Santos

    Senior Partner, Wheelhouse Life Science Advisors

    Primary Logo

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  17. SOUTH SAN FRANCISCO, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that AMT-101 has been named as a biotech innovation finalist in the Fierce Innovation Awards – Life Sciences Edition 2020, a peer-reviewed awards program based on the evaluation criteria of: effectiveness, technical innovation, competitive advantage, financial impact, and true innovation of a therapeutic. AMT-101 is the company's gut-selective, oral biologic fusion protein of interleukin 10 (IL-10) that will be entering into Phase 2 clinical trials.

    "We are excited to be selected as a finalist in the category of biotech innovation, which recognizes the breakthrough science…

    SOUTH SAN FRANCISCO, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced that AMT-101 has been named as a biotech innovation finalist in the Fierce Innovation Awards – Life Sciences Edition 2020, a peer-reviewed awards program based on the evaluation criteria of: effectiveness, technical innovation, competitive advantage, financial impact, and true innovation of a therapeutic. AMT-101 is the company's gut-selective, oral biologic fusion protein of interleukin 10 (IL-10) that will be entering into Phase 2 clinical trials.

    "We are excited to be selected as a finalist in the category of biotech innovation, which recognizes the breakthrough science employed in the design of our oral gastrointestinal-targeted biologic AMT-101," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "With AMT-101, we are able to leverage the potent immunomodulatory activity of IL-10 targeted directly to the immune-cell rich environment of the gastrointestinal (GI) tissue. Based on positive preclinical and clinical data, we are developing AMT-101 for the treatment of inflammatory disorders, with the most advanced program in ulcerative colitis (UC) and plan to initiate four Phase 2 studies. As a locally-targeted, GI-selective biologic therapeutic, oral AMT-101 has the potential to be used as a monotherapy or in combination with other therapeutic agents, in patients with moderate-to-severely active UC, including those who have failed prior biologic therapy or who are biologic-naive, and in a variety of indications beyond UC, including systemic inflammatory diseases. Our platform technology, which harnesses the power of natural active transport mechanisms within the GI tract and upon which AMT-101 was created, has the potential to create multiple oral biologic products in autoimmune, inflammatory, metabolic, and other diseases."

    The awards program, established by the publisher of Fierce Biotech and Fierce Pharma, highlights companies that demonstrated innovative solutions, technologies, and services that have the potential to make the greatest impact for biotech and pharma companies. The judges included an exclusive panel of executives from major biotech and pharma companies including Astellas, Accenture, AstraZeneca, Angiocrine Bioscience, Biotech Research Group, NIHR Clinical Research Network, Medidata Solutions and PPD. The winners will be announced in the 2020 Innovation Report set to publish by Fierce Life Sciences on September 14, 2020.

    About AMT-101

    AMT-101 is a GI-selective, oral fusion of rhIL-10 and its proprietary carrier molecule, which has been evaluated in a Phase 1b trial in ulcerative colitis (UC). AMT-101 is designed to cross the intestinal epithelium (IE) barrier while not entering the bloodstream, thereby focusing the drug directly at the site of action of the underlying biology of the disease in the gastrointestinal (GI) tissue and, therefore, potentially avoiding the side effects observed with systemic administration. By design, AMT-101 is actively transported through the IE barrier into the GI tissue, the primary site of inflammation in UC, a disease with approximately 2.2 to 2.4 million patients in the United States and Europe according to a 2014 report. As a locally-targeted, GI-selective biologic therapeutic, AMT-101 has potential use in a variety of inflammatory indications beyond UC.

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of therapeutic payloads across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing oral biologic product candidates in patient-friendly tablet and capsule forms that are designed for either targeting local gastrointestinal (GI) tissue or entering systemic circulation to precisely address the relevant biology of a disease. AMT is building a portfolio of oral product candidates based on its technology platform including its lead product candidate, AMT-101, an oral GI-selective interleukin 10 that has completed a Phase 1b clinical trial in patients with ulcerative colitis (UC). AMT further plans to initiate Phase 2 clinical trials of AMT-101 in UC and related inflammatory indications. AMT's technology platform enables it to design and develop various oral biologic therapeutic modalities, such as peptides, proteins, full-length antibodies, antibody fragments, and RNA therapeutics, with potentially significant advantages over existing marketed and development-stage drugs.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or AMT's future plans, strategy and performance. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including those more fully described in AMT's filings with the Securities and Exchange Commission ("SEC"), including AMT's prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, dated June 4, 2020 and in AMT's future reports to be filed with the SEC.  Any forward-looking statements contained in this press release speak only as of the date hereof, and AMT specifically disclaims any obligation to update any forward-looking statement, except as required by law.

    Contacts:

    Sylvia Wheeler

    Principal, Wheelhouse Life Science Advisors

    Alexandra Santos

    Senior Partner, Wheelhouse Life Science Advisors

     

    Primary Logo

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  18. SOUTH SAN FRANCISCO, Calif., June 09, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI), a clinical-stage biopharmaceutical company, today announced the closing of its initial public offering of 12,650,000 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase up to 1,650,000 additional shares, at a public offering price of $14.00 per share. The aggregate total gross proceeds to AMT from the offering were $177.1 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by AMT. AMT's common stock began trading on the Nasdaq Global Select Market on June 5, 2020, under the ticker symbol "AMTI…

    SOUTH SAN FRANCISCO, Calif., June 09, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI), a clinical-stage biopharmaceutical company, today announced the closing of its initial public offering of 12,650,000 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase up to 1,650,000 additional shares, at a public offering price of $14.00 per share. The aggregate total gross proceeds to AMT from the offering were $177.1 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by AMT. AMT's common stock began trading on the Nasdaq Global Select Market on June 5, 2020, under the ticker symbol "AMTI."

    BofA Securities, Jefferies and SVB Leerink acted as joint book-running managers for this offering.

    Registration statements relating to the offering of these securities have been filed with the Securities and Exchange Commission and became effective on June 4, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at ; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at 

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

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of therapeutic payloads across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing oral biologic product candidates in patient-friendly tablet and capsule forms that are designed for either targeting local gastrointestinal (GI) tissue or entering systemic circulation to precisely address the relevant biology of a disease. AMT is building a portfolio of oral product candidates based on its technology platform including its lead product candidate, AMT-101, an oral GI-selective interleukin 10 that has completed a Phase 1b clinical trial in patients with ulcerative colitis (UC). AMT further plans to initiate Phase 2 clinical trials of AMT-101 in UC and related inflammatory indications. AMT's technology platform enables it to design and develop various oral biologic therapeutic modalities, such as peptides, proteins, full-length antibodies, antibody fragments, and RNA therapeutics, with potentially significant advantages over existing marketed and development-stage drugs.

    Contacts:



    Sylvia Wheeler


    Principal, Wheelhouse Life Science Advisors

    Alexandra Santos

    Senior Partner, Wheelhouse Life Science Advisors

    Primary Logo

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  19. Pliant Therapeutics (NASDAQ:PLRX) began trading Wednesday, followed by Legend Biotech (NASDAQ:LEGN) and Applied Molecular Transport (NASDAQ:AMTI) on Friday. Other companies mentioned – Emmaus Life Sciences (OTCQB:EMMA)

    DENVER, Colo. – June 8, 2020 – The biotech IPO calendar kicked off last week when Pliant Therapeutics (NASDAQ:PLRX) began trading Wednesday, after pricing its initial public offering at $16 per share. All trading action, during the 3 sessions, has taken place between $21 and $26. The clinical stage biopharmaceutical company sold 9 million shares, 50% more than initial plan to issue just 6 million shares, to raise $144 million.

    The week ended with Legend Biotech (NASDAQ:LEGN) and Applied Molecular Transport (NASDAQ:AMTI) (AMT…

    Pliant Therapeutics (NASDAQ:PLRX) began trading Wednesday, followed by Legend Biotech (NASDAQ:LEGN) and Applied Molecular Transport (NASDAQ:AMTI) on Friday. Other companies mentioned – Emmaus Life Sciences (OTCQB:EMMA)

    DENVER, Colo. – June 8, 2020 – The biotech IPO calendar kicked off last week when Pliant Therapeutics (NASDAQ:PLRX) began trading Wednesday, after pricing its initial public offering at $16 per share. All trading action, during the 3 sessions, has taken place between $21 and $26. The clinical stage biopharmaceutical company sold 9 million shares, 50% more than initial plan to issue just 6 million shares, to raise $144 million.

    The week ended with Legend Biotech (NASDAQ:LEGN) and Applied Molecular Transport (NASDAQ:AMTI) (AMT) exceeding their initial pricing expectations.

    Legend Biotech priced its initial public offering, of 18,425,000 American depositary shares (ADSs), each representing two ordinary shares, at $23.00 per ADS, for total gross proceeds of approximately $424 million. The global clinical-stage biopharmaceutical company, which is engaged in the discovery and development of novel cell therapies for oncology and other indications, traded between $35-40 on Friday and granted the underwriters a 30-day option to purchase up to an additional 2,763,750 ADSs at the public offering price, less underwriting discounts and commissions.

    AMT expects to raise $154 million, less the underwriting discounts and commissions, for the 11 million Class A shares offered on Friday. The clinical-stage biopharmaceutical company traded between $26 and $17.15, after pricing of its common stock at $14.00 per share. Additionally, AMT granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of common stock at the initial public offering price, less fees.

    Emmaus Life Sciences (OTCQB:EMMA) (ELS), a leader in sickle cell anemia disease treatment, which didn’t IPO last week, continues to build on its recent operational updates, closed Friday’s session at $ 1.60 on just over 10,000 shares.

    ELS switched from a contract sales organization to its own direct sales force, which started on January 1, 2020, and continues to build its internal sales and marketing capabilities. In the first quarter of 2020, Emmaus increased sales by 10% over the preceding quarter and 39% over the same quarter of the prior year.

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    Cautionary Statement Regarding Forward Looking Information

    Statements in this press release about the Company’s future and expectations other than historical facts are “forward-looking statements.” These statements are made on the basis of management’s current views and assumptions. As a result, there can be no assurance that management’s expectations will necessarily come to pass. These forward-looking statements generally can be identified by phrases such as “believes,” “plans,” “expects,” “anticipates,” “foresees,” “estimated,” “hopes,” “if,” “develops,” “researching,” “research,” “pilot,” “potential,” “could” or other words or phrases of similar import. Forward looking statements include descriptions of the Company’s business strategy, outlook, objectives, plans, intentions and goals. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security.

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    To view the original version on ABNewswire visit: 24/7 Market News – Keep an eye on last week's Biotech IPOs

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  20. SOUTH SAN FRANCISCO, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI), a clinical-stage biopharmaceutical company, today announced the pricing of its initial public offering of 11,000,000 shares of common stock at a public offering price of $14.00 per share. All of the shares of common stock are being offered by AMT. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AMT, are expected to be $154.0 million, excluding any exercise of the underwriters' option to purchase additional shares. The shares are expected to begin trading on the Nasdaq Global Select Market on June 5, 2020, under the ticker symbol "AMTI." The offering is expected…

    SOUTH SAN FRANCISCO, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Applied Molecular Transport (NASDAQ:AMTI), a clinical-stage biopharmaceutical company, today announced the pricing of its initial public offering of 11,000,000 shares of common stock at a public offering price of $14.00 per share. All of the shares of common stock are being offered by AMT. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AMT, are expected to be $154.0 million, excluding any exercise of the underwriters' option to purchase additional shares. The shares are expected to begin trading on the Nasdaq Global Select Market on June 5, 2020, under the ticker symbol "AMTI." The offering is expected to close on June 9, 2020, subject to the satisfaction of customary closing conditions. In addition, AMT has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

    BofA Securities, Jefferies and SVB Leerink are acting as joint book-running managers for this offering.

    Registration statements relating to the shares being sold in this offering have been filed with the Securities and Exchange Commission and became effective on June 4, 2020. The offering will be made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at ; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at . Copies of the the final prospectus, when available, related to the offering will be available at www.sec.gov.

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

    About Applied Molecular Transport Inc.

    Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT's proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of therapeutic payloads across the intestinal epithelium (IE) barrier. Active transport is an efficient mechanism that uses the cell's own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing oral biologic product candidates in patient-friendly tablet and capsule forms that are designed for either targeting local gastrointestinal (GI) tissue or entering systemic circulation to precisely address the relevant biology of a disease. AMT is building a portfolio of oral product candidates based on its technology platform including its lead product candidate, AMT-101, an oral GI-selective interleukin 10 that has completed a Phase 1b clinical trial in patients with ulcerative colitis (UC). AMT further plans to initiate Phase 2 clinical trials of AMT-101 in UC and related inflammatory indications. AMT's technology platform enables it to design and develop various oral biologic therapeutic modalities, such as peptides, proteins, full-length antibodies, antibody fragments, and RNA therapeutics, with potentially significant advantages over existing marketed and development-stage drugs.

    Contacts:

    Sylvia Wheeler
    Principal, Wheelhouse Life Science Advisors

    Alexandra Santos
    Senior Partner, Wheelhouse Life Science Advisors

    Primary Logo

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