GlobeNewswire Inc | Nov 10, 2021 04:01PM EST

November 10, 2021

Top-line data readout for oral AMT-101 Phase 2 MARKET combination trial with anti-TNF in ulcerative colitis (UC) expected in H1 2022

Top-line data readouts from three additional oral AMT-101 Phase 2 trials, consistent with previous guidance

-- FILLMORE monotherapy trial in pouchitis in H1 2022 -- LOMBARD monotherapy trial in UC in H1 2022 -- CASTRO combination trial with anti-TNF in rheumatoid arthritis (RA) in H2 2022

Phase 1 enrollment ongoing for second product candidate, oral AMT-126, with program update in H1 2022

SOUTH SAN FRANCISCO, Calif., Nov. 10, 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 third quarter ended September 30, 2021.

I recognize the commitment of the AMT team as we drive towards significant milestones over the next 12 months, said Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. We are excited about the broad potential of our two product candidates, AMT-101 and AMT-126, for treating intestinal and systemic inflammatory indications and other diseases.

Recent Business Highlights and Anticipated Milestones

-- Hosted virtual Research & Development Day to highlight novel oral biologics technology platform, clinical programs and research activities Announced new respiratory carrier technology and presented preclinical data on the approachFeatured distinguished IBD and rheumatology key opinion leaders -- Actively enrolling and dosing in four Phase 2 trials for AMT-101, a GI-selective, oral IL-10 fusion: MARKET combination trial of oral AMT-101 with anti-TNF in biologic-nave patients with moderate-to-severe UC; Top-line data readout in H1 2022 Following the Companys R&D Day event, the Company was notified of a potential imbalance in the trials planned 1:1 randomization. Upon confirmation of the imbalance, the Company now anticipates increasing total enrollment from 30 patients to between 40 and 50 patients. The trial has been and continues to be blinded.FILLMORE monotherapy trial for patients with chronic pouchitis; Top-line data readout in H1 2022LOMBARD monotherapy trial for biologic-nave and experienced patients with moderate-to-severe UC; Top-line data readout in H1 2022CASTRO combination trial of oral AMT-101 with anti-TNF for patients with RA who are partial or non-responders to anti-TNF therapy; Top-line data readout in H2 2022 -- Enrollment ongoing in Phase 1 trial with AMT-126, a GI-selective, oral IL-22 fusion: Phase 1 development plan includes healthy volunteers and patientsBroad potential in multiple indications in patients with impaired intestinal epithelial barrier functionProgram update from oral AMT-126 in H1 2022 -- Appointed Holly Schachner, M.D., a seasoned and accomplished industry veteran to the companys Board of Directors -- Presented additional positive data from oral AMT-101 Phase 1b multiple ascending dose trial in UC patients at the ECCO21 Virtual Congress in July 2021

Financial Results for the Third Quarter Ended September 30, 2021

Research and development (R&D) expenses. Total R&D expenses for the third quarter of 2021 were $18.4 million, compared to $13.4 million for the same period in 2020. The overall increase was primarily related to an increase in expenses associated with compensation due to an increase in headcount, along with increases in facility related expenses, clinical trials, and materials, partially offset by a decrease in preclinical studies and contract manufacturing.

General and administrative (G&A) expenses. Total G&A expenses for the third quarter of 2021 were $7.6 million, compared to $3.4 million for the same period in 2020. The overall increase was primarily related to an increase of $3.0 million in personnel and administrative costs due to an increase in headcount and an increase of $1.0 million in professional fees.

Net loss. Net loss for the third quarter of 2021 was $26.0 million, compared to $16.8 million for the same period in 2020.

Cash, cash equivalents, and investments. As of September 30, 2021, cash, cash equivalents and investments were $182.5 million.

About AMT-101

AMT-101 is a novel GI-selective, oral fusion of hIL-10 and AMTs proprietary carrier molecule, currently in development 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 AMTs 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. AMTs 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 cells 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.

AMTs 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 AMTs plans, expectations, forecasts and future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding AMTs technology platform and AMTs internal manufacturing capabilities, statements regarding the optimization or expansion of our product development plans or the design of future clinical trials, statements regarding the potential of AMT-101, AMT-126, AMTs respiratory carrier technology or regarding AMT-101 and AMT-126 clinical trials, including the timing of data readouts from such trials and program updates, milestones for such trials, and our ability to replicate past clinical development strategies, statements regarding the potential for AMTs 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 believe, 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 AMTs Annual and Quarterly Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission (the SEC), and AMTs 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)

September30, December31, 2021 2020 Assets Current assets: Cash and cash equivalents $ 152,455 $ 5,843 Short-term investments 30,069 124,026 Prepaid expenses 4,503 1,311 Other current assets 634 321 Total current assets 187,661 131,501 Property and equipment, net 6,445 8,447 Operating lease right-of-use assets, net 11,173 ? Finance lease right-of-use assets, net 700 ? Restricted cash 1,025 108 Other assets 52 127 Total assets $ 207,056 $ 140,183 Liabilities and stockholders? equity Current liabilities: Accounts payable $ 1,411 $ 3,174 Accrued expenses 5,915 4,173 Operating lease liabilities, current 2,164 ? Finance lease liabilities, current 242 ? Deferred rent, current ? 83 Capital lease obligations, current ? 232 Total current liabilities 9,732 7,662 Operating lease liabilities 9,582 ? Finance lease liabilities 221 ? Deferred rent ? 444 Capital lease obligations ? 404 Total liabilities 19,535 8,510 Commitments and contingencies Stockholders? equity: Common stock 4 4 Additional paid-in capital 396,958 271,000 Accumulated other comprehensive income 1 27 Accumulated deficit (209,442 ) (139,358 )Total stockholders? equity 187,521 131,673 Total liabilities and stockholders? equity $ 207,056 $ 140,183

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 September30, September30, 2021 2020 2021 2020 Operating expenses:Research and $ 18,350 $ 13,395 $ 49,765 $ 39,185 developmentGeneral and 7,641 3,428 20,333 8,404 administrativeTotal operating 25,991 16,823 70,098 47,589 expensesLoss from (25,991 ) (16,823 ) (70,098 ) (47,589 )operationsInterest income, 5 59 104 187 netOther expense, (6 ) (29 ) (90 ) (81 )netNet loss $ (25,992 ) $ (16,793 ) $ (70,084 ) $ (47,483 )Net loss pershare, basic and $ (0.68 ) $ (0.48 ) $ (1.88 ) $ (2.53 )dilutedWeighted-averageshares of commonstock 38,437,096 34,767,308 37,273,178 18,770,153 outstanding,basic anddilutedComprehensive loss:Net loss $ (25,992 ) $ (16,793 ) $ (70,084 ) $ (47,483 )Othercomprehensive (loss) income:Unrealized(loss) gain on (5 ) 29 (26 ) 37 investmentsAmountsrecognized fornet realized ? ? ? (19 )gains includedin net lossTotalcomprehensive $ (25,997 ) $ (16,764 ) $ (70,110 ) $ (47,465 )loss

Refer to the Companys applicable SEC filings for previously reported periods.

Investor Relations Contact:Andrew ChangHead, Investor Relations & Corporate Communicationsachang@appliedmt.com

Media Contacts:Alexandra SantosWheelhouse Life Science Advisorsasantos@wheelhouselsa.com

Aljanae ReynoldsWheelhouse Life Science Advisorsareynolds@wheelhouselsa.com