AMTI Applied Molecular Transport Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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AMT-101 (MARKET)
Ulcerative colitis
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Phase 2
Phase 2
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AMT-101 (CASTRO)
Rheumatoid arthritis
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Phase 2
Phase 2
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AMT-101 (FILLMORE)
Pouchitis
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Phase 2
Phase 2
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AMT-101 (LOMBARD)
Ulcerative colitis
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Phase 2
Phase 2
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AMT-126
Healthy volunteers
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Phase 1a
Phase 1a
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Latest News
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Enrollment ongoing in each of oral AMT-101's four Phase 2 trials
On track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials, being conducted in multiple ulcerative colitis populations and rheumatoid arthritis, beginning in the second half of 2021 and into 2022
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
Received acceptance to present full AMT-101 Phase 1b ulcerative colitis data at ECCO'21 Virtual Congress in July
Strengthened balance sheet with successful follow-on offering in April
SOUTH SAN FRANCISCO, Calif., May 13, 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 first quarter ended March 31, 2021.
"Our proprietary technology platform and internal CMC capabilities have enabled AMT to generate differentiated novel oral biologics, and this broad platform continues to generate exciting pipeline opportunities," said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. "Following the initiation of our second clinical program, oral AMT-126, in a Phase 1a trial in healthy volunteers, we further strengthened our balance sheet with a successful follow-on offering in April. Importantly, these proceeds will enable AMT to optimize the development plan for oral AMT-126 and our next pipeline programs as they advance towards the clinic. We continue to believe that our most advanced programs, AMT-101 and AMT-126, have broad potential for targeting intestinal and systemic inflammatory indications and other diseases. With topline readouts from the four Phase 2 trials beginning in the second half of the year, we expect the next twelve to eighteen months to be a data-rich period for the company."
Recent Business Highlights
- Initiated Phase 2 trials for oral AMT-101:
- MARKET combination trial of oral AMT-101 with anti-TNFα in biologic-naïve patients with moderate-to-severe ulcerative colitis (UC)
- FILLMORE monotherapy trial for patients with chronic pouchitis
- CASTRO combination trial of oral AMT-101 with anti-TNFα for patients with rheumatoid arthritis who are partial or non-responders to anti-TNFα therapy
- Expanded clinical pipeline with second wholly internally-developed biologic therapeutic, 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; Expect to conduct a Phase 1b trial in patients with impaired intestinal epithelial barrier function.
- Closed an underwritten public offering in April of 2,875,000 shares of our common stock, at a public offering price of $42.00 per share, resulting in net proceeds of approximately $112.9 million. Cash, cash equivalents, and investments as of March 31, 2021 pro-forma for the public offering were approximately $229.1M.
- Successfully manufactured oral AMT-101 and AMT-126 GMP biologics at AMT's internal manufacturing facility
- Received acceptance for our submission to present the full AMT-101 Phase 1b multiple ascending dose UC data set at the ECCO'21 Virtual Congress in July 2021
- Strengthened the executive leadership team with key new hires, including Douglas Rich, chief technical officer, and Earl Douglas, executive vice president and general counsel
Anticipated Upcoming Milestones
- Top-line data readouts from the four oral AMT-101 Phase 2 trials beginning in 2H 2021 and into 2022
- Top-line oral AMT-126 Phase 1a/b data in healthy volunteers and patients in 2022
Financial Results for the First Quarter Ended March 31, 2021
Research and development (R&D) expenses. Total R&D expenses for the first quarter of 2021 were $14.9 million, compared to $13.0 million for the same period in 2020. The increase was primarily due to higher expenses associated with clinical trials, preclinical studies, compensation and facilities related expenses, offset by a decrease in materials and contract manufacturing.
General and administrative (G&A) expenses. Total G&A expenses for the first quarter of 2021 were $5.6 million, compared to $2.5 million for the same period in 2020. The increase was primarily due to an increase of $1.9 million in personnel and administrative costs due to an increase in headcount and an increase of $1.1 million in professional fees.
Net loss. Net loss for the first quarter of 2021 was $20.5 million, compared to $15.3 million for the same period in 2020.
Cash, cash equivalents, and investments. As of March 31, 2021, cash, cash equivalents, and investments were $108.3 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 epithelial (IE) 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 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 epithelial (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 intestinal 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 and AMT's internal manufacturing capabilities, statements regarding the optimization of our product development plans or the design of future clinical trials, statements regarding the potential of AMT-101 and AMT-126 or regarding AMT-101 and AMT-126 clinical trials, including the timing of data readouts from such trials and our ability to replicate past clinical development strategies, statements regarding the potential for AMT's product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and assumptions regarding the biological mode of action of our product candidates and the potential to avoid side effects with our product candidates. In some cases, you can identify forward-looking statements by terminology such as "estimate," "intend," "may," "plan," "potentially," "will," "expect," "enable" 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. Actual events, trends or results could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements based on various factors. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in AMT's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission (the "SEC"), 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)March 31, December 31, 2021 2020 Assets Current assets: Cash and cash equivalents $ 26,202 $ 5,843 Short-term investments 82,063 124,026 Prepaid expenses 2,648 1,311 Deferred offering costs 659 — Other current assets 393 321 Total current assets 111,965 131,501 Property and equipment, net 6,999 8,447 Operating lease right-of-use assets, net 5,450 — Finance lease right-of-use assets, net 796 — Restricted cash 1,025 108 Other assets 169 127 Total assets $ 126,404 $ 140,183 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 2,208 $ 3,174 Accrued expenses 4,094 4,173 Operating lease liabilities, current 2,377 — Finance lease liabilities, current 235 — Deferred rent, current — 83 Capital lease obligations, current — 232 Total current liabilities 8,914 7,662 Operating lease liabilities 3,589 — Finance lease liabilities 344 — Deferred rent — 444 Capital lease obligations — 404 Total liabilities 12,847 8,510 Commitments and contingencies (Note 6) Stockholders' equity: Common stock, $0.0001 par value, 450,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 35,250,650 and 35,121,360 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 4 4 Additional paid-in capital 273,348 271,000 Accumulated other comprehensive income 25 27 Accumulated deficit (159,820 ) (139,358 ) Total stockholders' equity 113,557 131,673 Total liabilities and stockholders' equity $ 126,404 $ 140,183 Applied Molecular Transport Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)Three Months Ended March 31, 2021 2020 Operating expenses: Research and development $ 14,881 $ 12,954 General and administrative 5,599 2,489 Total operating expenses 20,480 15,443 Loss from operations (20,480 ) (15,443 ) Interest income, net 40 83 Other (expense) income, net (22 ) 49 Net loss $ (20,462 ) $ (15,311 ) Net loss per share, basic and diluted $ (0.58 ) $ (2.06 ) Weighted-average shares of common stock outstanding, basic and diluted 35,217,773 7,417,440 Comprehensive loss: Net loss $ (20,462 ) $ (15,311 ) Other comprehensive (loss) income: Unrealized (loss) gain on investments (2 ) 6 Total comprehensive loss $ (20,464 ) $ (15,305 ) Refer to the Company's applicable SEC filings for previously reported periods.
Investor Relations Contact:
Andrew Chang
Head, Investor Relations & Corporate Communications
[email protected]Media Contacts:
Alexandra Santos
Wheelhouse Life Science Advisors
[email protected]Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]
- Initiated Phase 2 trials for oral AMT-101:
-
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SOUTH SAN FRANCISCO, Calif., May 06, 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 BofA Securities 2021 Health Care Conference on Wednesday, May 12, 2021 at 2:00 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 epithelial (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
[email protected]Media Contacts:
Alexandra Santos
Wheelhouse Life Science Advisors
[email protected]Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected] -
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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 [email protected]; 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 prospectus_de[email protected]; 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 [email protected] 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
[email protected]Media Contacts:
Alexandra Santos
Wheelhouse Life Science Advisors
[email protected]Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected] -
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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 [email protected]; 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 [email protected]; 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 [email protected] 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
[email protected]Media Contacts:
Alexandra Santos
Wheelhouse Life Science Advisors
[email protected]Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected] -
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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 [email protected]; 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 [email protected]; 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 [email protected].
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
[email protected]Media Contacts:
Alexandra Santos
Wheelhouse Life Science Advisors
[email protected]Aljanae Reynolds
Wheelhouse Life Science Advisors
[email protected]