Extremely low birth weight infant

--Enrollment ongoing for patients with microsatellite stability (MSS) colorectal cancer (CRC) in Phase1/2 trial of NGM707, a dual ILT2/ILT4 antagonist antibody product candidate, in combination with KEYTRUDA® (pembrolizumab) with expected completion of enrollment in the second quarter of 2024-- --Announced ongoing toxicology activities intended to support initiation of a potential proof-of-concept study of NGM120, a GDF15/GFRAL antagonist, for the treatment of hyperemesis gravidarum (HG) by the end of 2024-- --Ongoing discussions with regulators on the design of a potential registrational trial of aldafermin, an engineered FGF19 analog, for the treatment of primary sclerosing cholangitis (PSC), a rare liver disease, using surrogate endpoints-- --Reported $144.2 million in cash, cash equivalents and marketable securities as of December 31, 2023-- --On February 26, 2024, announced that it had entered into the Agreement and Plan of Merger with Atlas Neon Parent, Inc., and Atlas Neon Merger Sub, Inc.-- SOUTH SAN FRANCISCO, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc., (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today provided recent business highlights and reported financial results for the fourth quarter and full year ended December 31, 2023. “In 2023, we made significant progress in patient enrollment in trials of our solid tumor drug candidates. Most notably, we are encouraged by the signals of activity observed in our NGM707 Phase 1b trial, particularly among MSS CRC patients whose lesions are typically unresponsive to immuno-checkpoint therapies. We also made progress in our discussions with the FDA regarding the design of a potential registrational Phase 2 study of aldafermin in PSC using a primary endpoint composed of surrogate biomarkers of PSC progression and obtained orphan drug designation from the agency for aldafermin for the treatment of PSC,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. “In 2024, we are focused on completing patient enrollment for NGM707 with a potential interim Phase 1b trial readout in the middle of the year, initiating a potential Phase 2 proof-of-concept trial of NGM120 in HG by the end of 2024, and, provided we have the financial resources and agreement on trial design, initiating a registrational Phase 2 trial of aldafermin in PSC patients. Our priority remains to seek licensing and other business development partners across all our wholly-owned product candidates and to allocate our resources to the programs that we believe have the greatest potential both in the near- and long-term.” Key Fourth Quarter and Recent Highlights Solid Tumor Oncology Disclosed in January 2024 encouraging findings in a Phase 1 Part 1b cohort of the ongoing Phase 1/2 trial evaluating NGM707 in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors, including MSS CRC patients. 46 patients were enrolled as of the November 6, 2023 data-cutoff and, of the 37 response-evaluable patients (those completing at least one on-treatment scan), there were four confirmed partial responses across multiple indications, including one pathological complete response, and 12 patients with stable disease (11% overall response rate and 43% disease control rate). The combination of NGM707 and pembrolizumab was generally well-tolerated at all four doses (200, 600, 1200, 1800 mg) of NGM707. The maximum tolerated dose was not reached. NGM Bio expects to complete enrollment in the Phase 1 Part 1b cohort in the second quarter of 2024 and anticipates providing an update in mid-2024 on the fully enrolled cohort and subsequent next steps, including, provided sufficient financial resources, the potential for additional cohorts, which NGM Bio expects will include MSS CRC patients. Completed enrollment in the Phase 1 Part 1b cohorts of the Phase 1/1b trials evaluating NGM831, an ILT3 antagonist antibody product candidate, and NGM438, a LAIR1 antagonist antibody product candidate, in combination with pembrolizumab in patients with advanced solid tumors. NGM831 and NGM438, alone and in combination with pembrolizumab, have been generally well-tolerated and there have been no dose limiting toxicities noted to date. Initiated an ongoing Phase 1, Part 1c dose finding cohort evaluating the triplet combination of NGM831, NGM438 and pembrolizumab. This cohort is anticipated to complete enrollment in the first half of 2024. Hyperemesis Gravidarum Announced in January 2024 potential development of NGM120 for the treatment of HG. NGM120, a GFRAL antagonist antibody, is designed to block GDF15 signaling, the central cause of HG and, thereby, may potentially have therapeutic benefit for treating pregnant women suffering from HG. HG is a rare, serious condition that affects approximately 100,000 – 150,000 women in the United States each year during pregnancy and is characterized by intractable nausea and vomiting, which then results in dehydration, weight loss and malnutrition. HG has a significant physical and psychosocial impact on patients and leads to overall higher rates of fetal loss, preeclampsia, preterm birth, low birth weight and fetal malnutrition. HG is the second leading cause of hospitalization in pregnancy (second to preterm labor) and typically recurs in subsequent pregnancies. There are currently no FDA-approved therapies for this condition. Research1 has shown that GDF15 levels increase steadily in early pregnancy and, on average, are higher in women who experience nausea and vomiting in pregnancy and HG. The research also indicated that women with GDF15 genetic variants associated with lower levels of GDF15 in a non-pregnant state are predisposed to HG. NGM Bio’s goal is to initiate a Phase 2 proof-of-concept study of NGM120 for the treatment of HG by the end of 2024. NGM Bio is in the process of producing a toxicology package to submit to regulatory authorities in Australia or the United Kingdom that we hope will support initiation of the trial. Aldafermin Presented positive Phase 2b results from the ALPINE 4 trial of aldafermin in compensated cirrhosis (F4) due to NASH at AASLD The Liver Meeting in November 2023. In January 2024, announced U.S. Food and Drug Administration (FDA) granted orphan drug designation to aldafermin, an engineered FGF19 analog, for the treatment of PSC. NGM Bio plans to further develop aldafermin for the treatment of PSC, a rare liver disease that irreparably damages the bile ducts, leading to bile acid dysregulation, which, ultimately, results in serious liver damage. There are currently no FDA-approved therapies for PSC. NGM Bio is continuing discussions with the FDA regarding the design of a potential registrational trial of aldafermin in PSC, including on the proposed utilization of a primary endpoint composed of surrogate biomarkers with the goal of obtaining accelerated approval from the FDA. NGM Bio plans to continue working towards the goal of initiating a potential registrational trial contingent upon further discussion with the FDA on trial design and obtaining the additional capital necessary to conduct the study. Corporate On February 26, 2024, NGM Bio announced that it had entered into the Agreement and Plan of Merger (Merger Agreement) with Atlas Neon Parent, Inc. (Parent) and Atlas Neon Merger Sub, Inc., a wholly-owned subsidiary of Parent (Merger Sub). The Merger Agreement provides for, among other things, (i) the acquisition of NGM Bio by Parent through a cash tender offer (the Offer) by Merger Sub for each issued and outstanding share of NGM Bio’s common stock (other than certain rollover shares) for $1.55 per share (the Offer Price), and (ii) the merger of Merger Sub with and into NGM Bio (the Merger), with NGM Bio surviving the Merger as a privately held company. Subject to the terms of the Merger Agreement, the Offer Price will be paid subject to any applicable tax withholding and without interest. Pursuant to the Merger Agreement, on March 8, 2024, Parent commenced the Offer. Additional details can be found in NGM Bio’s recent filings with the United States Securities and Exchange Commission (SEC). NGM Bio anticipates that the Offer and the Merger contemplated under the Merger Agreement will be consummated in the second quarter of 2024. However, closing of the Merger is subject to customary closing conditions, and there can be no assurance that the Offer and the Merger contemplated by the Merger Agreement will be completed. If the Merger is effected, NGM Bio’s common stock will be delisted from The Nasdaq Stock Market LLC and NGM Bio will be privately held. Fourth Quarter and Full Year 2023 Financial Results NGM Bio reported a net loss of $27.7 million and $142.4 million for the quarter and year ended December 31, 2023, respectively, compared to a net loss of $36.4 million and $162.7 million for the same periods in 2022. Related party revenue from the collaboration with Merck Sharp & Dohme LLC, or Merck, was $0.2 million and $4.4 million for the quarter and year ended December 31, 2023, respectively, compared to $18.2 million and $55.3 million for the same periods in 2022. The collaboration with Merck ends on March 31, 2024. Research and development expenses were $21.9 million and $118.0 million for the quarter and year ended December 31, 2023, respectively, compared to $46.7 million and $181.1 million for the same periods in 2022. General and administrative expenses were $7.9 million and $37.8 million for the quarter and year ended December 31, 2023, respectively, compared to $9.8 million and $40.5 million for the same periods in 2022. Cash, cash equivalents and short-term marketable securities were $144.2 million as of December 31, 2023. About NGM Biopharmaceuticals, Inc. NGM Bio is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. The company’s biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates and enable their rapid advancement into proof-of-concept studies. As explorers on the frontier of life-changing science, NGM Bio aspires to operate one of the most productive research and development engines in the biopharmaceutical industry. All therapeutic candidates in the NGM Bio pipeline have been generated by its in-house discovery engine, always led by biology and motivated by unmet patient need. Visit us at for more information. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Abbreviations (in Alphabetical Order) F4=fibrosis stage 4; FGF19=fibroblast growth factor 19; GDF15=growth differentiation factor 15; GFRAL=glial cell-derived neurotrophic factor receptor alpha-like; HG=hyperemesis gravidarum; NASH=nonalcoholic steatohepatitis; ILT2=immunoglobin-like transcript 2; ILT3=immunoglobin-like transcript 3; ILT4=immunoglobin-like transcript 4; LAIR1=leukocyte-associated immunoglobulin-like receptor 1 Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “encouraged”, “will,” “could,” “expect,” “expected,” “promising,” “aspires,” “aims,” “hope” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to: the therapeutic potential of NGM Bio’s product candidates; NGM Bio’s continued pipeline development, including identification and engagement of third-party partners for potential future business development arrangements, or the BD Arrangements, across all NGM Bio’s wholly-owned product candidates and to allocate its resources to the programs that it believes have the greatest potential both in the near- and long-term and; research and development and discovery engine output; the expected timing of completion of enrollment of NGM Bio’s ongoing Phase 1 Part 1b cohort of the Phase1/2 trial of NGM707 in combination with KEYTRUDA® (pembrolizumab) and timing of anticipated updates on the completed cohort and subsequent next steps, including the potential for additional cohorts; timing of the potential start of NGM120 in a proof-of-concept study for the treatment of HG; the design and initiation of a potential registrational trial for aldafermin for the treatment of PSC using surrogate endpoints; timing of completion of enrollment of NGM Bio’s ongoing Phase 1, Part 1c dose finding cohort evaluating the triplet combination of NGM831, NGM438 and pembrolizumab; the potential therapeutic benefit of NGM120 for treating pregnant women suffering from HG; the ability of NGM Bio and Atlas Neon Parent, Inc., a Delaware corporation (Parent), and Atlas Neon Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of Parent (together with Parent, the Purchaser) to complete the transactions contemplated by the Merger Agreement, including the parties’ ability to satisfy the conditions to the consummation of the Offer and the other conditions set forth in the Merger Agreement, statements about the expected timetable for completing the transactions, NGM Bio’s and Purchaser’s beliefs and expectations and statements about the benefits sought to be achieved by Purchaser’s proposed acquisition of NGM Bio, the possibility of any termination of the Merger Agreement, estimates relating to NGM Bio’s past, current or future financial condition; and other statements that are not historical fact. Because such statements deal with future events and are based on NGM Bio’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of NGM Bio could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to failure or delays in successfully initiating, enrolling, reporting data from or completing clinical studies, as well as the risks that results obtained in preclinical or clinical trials to date may not be indicative of results obtained in future trials; the lack of regulatory clarity regarding acceptable surrogate endpoints for PSC and related development uncertainty; the vulnerable patient population experiencing HG and risks associated with clinical trials on such patient population; uncertainties inherent in the preclinical development process of NGM120 in HG, including that NGM120 in HG may never reach clinical development; NGM Bio’s ability to identify, attract and engage third-party partners for BD Arrangements for its wholly-owned programs; the time-consuming and uncertain regulatory approval process; NGM Bio’s reliance on third-party manufacturers for its product candidates and the risks inherent in manufacturing and testing pharmaceutical products; the sufficiency of NGM Bio’s cash resources and expected cash runway, including the risk that NGM Bio could utilize its available capital resources sooner than it currently expects and its need for additional capital; macroeconomic conditions (such as the impacts of global geopolitical conflict, global economic slowdown, increased inflation, rising interest rates and recent and potential future bank failures); the timing of the Offer and the subsequent Merger; uncertainties as to how many of the unaffiliated stockholders will tender their shares in the Offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the Offer and the subsequent Merger may not be satisfied or waived; the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement, including in circumstances which would require NGM Bio to pay a termination fee; the effects of disruption from the transactions contemplated by the Merger Agreement; the risk that stockholder litigation in connection with the Offer or the Merger may result in significant costs of defense, indemnification and liability; and other risks and uncertainties affecting NGM Bio and its development programs, including those discussed in the section titled “Risk Factors” in NGM Bio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the SEC on November 2, 2023 and future filings and reports that NGM Bio makes from time to time with the SEC. Except as required by law, NGM Bio assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements. Investor Contact: ir@ngmbio.com Media Contact: media@ngmbio.com 1 Fejzo, M., Rocha, N., Cimino, I. et al. GDF15 linked to maternal risk of nausea and vomiting during pregnancy. Nature (2023). NGM BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022* Related party revenue $ 165 $ 18,181 $ 4,417 $ 55,333 Operating expenses: Research and development 21,890 46,722 118,040 181,067 General and administrative 7,938 9,756 37,840 40,515 Total operating expenses 29,828 56,478 155,880 221,582 Loss from operations (29,663 ) (38,297 ) (151,463 ) (166,249 ) Interest income, net 2,041 2,030 9,322 3,714 Other expense, net (48 ) (170 ) (234 ) (132 ) Net loss $ (27,670 ) $ (36,437 ) $ (142,375 ) $ (162,667 ) Net loss per share, basic and diluted $ (0.33 ) $ (0.45 ) $ (1.73 ) $ (2.03 ) Weighted average shares used to compute net loss per share, basic and diluted 82,803 81,787 82,496 79,950 ___________ * Derived from the audited consolidated financial statements. NGM BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited) December 31, 2023 December 31, 2022* ASSETS Current assets: Cash and cash equivalents $ 55,816 $ 73,456 Short-term marketable securities 88,369 198,036 Related party receivable from collaboration 58 7,580 Prepaid expenses and other current assets 9,202 9,787 Restricted cash 2,999 — Total current assets 156,444 288,859 Property and equipment, net 7,033 8,496 Operating lease right-of-use asset — 2,096 Restricted cash 2,455 3,954 Other non-current assets 2,936 3,997 Total assets $ 168,868 $ 307,402 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 2,982 $ 8,453 Accrued liabilities 17,099 33,638 Operating lease liability, current — 5,385 Contract liabilities — 366 Total current liabilities 20,081 47,842 Other non-current liabilities 149 — Total liabilities 20,230 47,842 Commitments and contingencies Stockholders' equity: Preferred stock, $0.001 par value — — Common stock, $0.001 par value 83 82 Additional paid-in capital 872,545 841,413 Accumulated other comprehensive income (loss) 18 (302 ) Accumulated deficit (724,008 ) (581,633 ) Total stockholders' equity 148,638 259,560 Total liabilities and stockholders' equity $ 168,868 $ 307,402 ___________ * Derived from the audited consolidated financial statements.

Encouraging findings in heavily pretreated patients in multiple solid tumor indications, including MSS colorectal cancer (CRC), in ongoing Phase 1 Part 1b study evaluating NGM707, a dual ILT2/ILT4 antagonist antibody, in combination with KEYTRUDA® (pembrolizumab) Aldafermin, an engineered FGF19 analog, has been granted Orphan Drug Designation by the FDA for the treatment of primary sclerosing cholangitis (PSC), a rare liver disease Initiating design of a potential registrational trial of aldafermin in PSC and in discussion with the FDA on utilizing proposed surrogate endpoints with the goal of obtaining accelerated approval Large body of clinical data, including from NGM Bio’s prior Phase 2 study in PSC, supports aldafermin’s differentiated potential to address the bile acid dysregulation underpinning PSC NGM120, a GDF15/GFRAL antagonist, has strong biologic rationale for the treatment of hyperemesis gravidarum Discussing design of an acceptable toxicology package to support clinical trials in hyperemesis gravidarum patients in ongoing dialogue with the FDA Recent evidence suggests this rare, devastating condition is linked to higher levels of, and greater sensitivity to, GDF15 during pregnancy NGM Bio is a long-time pioneer in elucidating GDF15 biology, including identifying its cognate receptor, GFRAL SOUTH SAN FRANCISCO, Calif., Jan. 09, 2024 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced encouraging new data from an ongoing Phase 1 Part 1b study evaluating NGM707, a dual ILT2/ILT4 antagonist antibody product candidate, in combination with KEYTRUDA® (pembrolizumab). NGM Bio also outlined its strategy to evolve clinical development of its product candidates aldafermin and NGM120 to focus on rare conditions characterized by significant unmet need. “Our priorities for 2024 center on directing our efforts and investing our resources as efficiently and effectively as possible toward select development activities that we believe have the greatest potential to deliver nearer-term impact and value creation while being fully aligned with our mission to deliver life-changing medicines for patients with significant unmet needs,” said David J. Woodhouse, PhD, Chief Executive Officer at NGM Bio. Dr. Woodhouse continued, “Our focus on the combination of NGM707 and pembrolizumab stems from encouraging responses observed in heavily pretreated patients with very advanced disease, including MSS CRC, that has been largely unresponsive to anti-PD-1/L1 monotherapy. Our interest and efforts in aldafermin in PSC are based on data that we believe supports aldafermin’s differentiated potential as an engineered FGF19 analog to address the bile acid dysregulation underpinning this rare liver disease, including our prior Phase 2 study in PSC, as well as our positive clinical study in NASH F4 patients and data from other PSC trials supporting the use of biomarkers of fibrosis, such as ELF, to predict clinical outcomes. Finally, our potential exploration of NGM120, a GDF15/GFRAL antagonist, in a proof-of-concept study for the treatment of hyperemesis gravidarum is rooted in our decade-long efforts advancing the understanding of GDF15 biology and exploring its therapeutic application in a number of disease areas. Recent landmark genetic research confirmed the link between this rare, devastating condition experienced during pregnancy to higher levels of GDF15. Given our deep expertise in GDF15 biology, we believe we are well positioned to potentially pursue this indication for NGM120. As we concurrently pursue these important development efforts, exploring partnering opportunities across our full product candidate and research portfolio, all wholly owned by NGM, remains an important priority for us in 2024.” Key Pipeline Updates NGM707 in Advanced Solid Tumors Announced encouraging new findings from the Phase 1 Part 1b dose escalation cohort of the ongoing Phase 1/2 trial evaluating NGM707 in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors. The combination of NGM707 and pembrolizumab was generally well tolerated at all four dose levels of NGM707. The maximum tolerated dose was not reached. The Phase 1 Part 1b cohort enrolled 46 patients as of a November 6, 2023 data-cutoff. Of 37 response-evaluable patients (those completing at least one on-treatment scan), there were four confirmed partial responses (PRs) across multiple indications, including one pathological complete response (CR), and 12 stable disease (SD) (11% overall response rate [ORR] and 43% disease control rate [DCR]). The pathological CR patient had significant target lesion reduction that allowed subsequent surgical resection of all gross residual disease, resulting in a confirmed pathological CR with no active tumor cells and ctDNA below detection. Three of the four responders had active liver metastases at baseline; patients with liver metastases, which are associated with immune suppression and lower survival rates, tend to have a reduced response to immunotherapy. Eight of the 37 response-evaluable patients had MSS CRC; two of these MSS CRC patients were among the confirmed PRs, including the patient with a pathological CR, and two had SD (25% ORR and 50% DCR). Anti-PD-1/L1 monotherapies have shown low or no benefit in MSS CRC patients. NGM Bio is completing enrollment in the Phase 1 Part 1b cohort and anticipates providing an update in mid-2024 on the completed cohort and subsequent next steps, including the potential for additional cohorts, which may include MSS CRC patients. Aldafermin in Primary Sclerosing Cholangitis (PSC) Announced planned further development of aldafermin for the treatment of PSC, a rare liver disease that irreparably damages the bile ducts, leading to bile acid dysregulation, which, ultimately, results in serious liver damage. There are currently no FDA-approved therapies for PSC. NGM Bio recently met with the FDA regarding the design of a potential registrational trial, including the utilization of proposed surrogate primary endpoints. NGM Bio plans to continue working with the FDA to reach agreement on a trial design in the coming months, with the goal of initiating trial enrollment by the end of 2024, contingent upon reaching agreement with the FDA on trial design and additional capital availability. NGM Bio’s decision to pursue the potential further clinical development of aldafermin as a treatment for PSC was informed by a large body of clinical data. Over 800 patients across multiple indications have been treated with aldafermin, which has repeatedly demonstrated powerful bile acid suppression in patients with PSC and NASH, and thus, NGM Bio believes aldafermin has the differentiated potential to directly address the underlying biology of PSC. NGM Bio previously reported data from a randomized, double-blind, placebo-controlled Phase 2 study of aldafermin for the treatment of PSC. While that Phase 2 study did not meet its primary endpoint of statistically significant change in alkaline phosphatase, an exploratory biomarker of PSC disease progression, from baseline to week 12, aldafermin demonstrated both statistically significant improvements in biomarkers of hepatic injury and fibrosis, as well as statistically significant reductions in biomarkers of bile acid synthesis and serum bile acids, consistent with past studies of aldafermin in other liver diseases. The Phase 2 study met the secondary endpoints and was generally well tolerated by patients. NGM120 in Hyperemesis Gravidarum Announced potential development of NGM120 for the treatment of hyperemesis gravidarum (referred to colloquially as hyperemesis), subject to the outcome of ongoing discussions with the FDA. Hyperemesis, a rare, serious condition that affects approximately 100,000 – 150,000 women in the United States each year during pregnancy, is characterized by intractable nausea and vomiting, which then results in dehydration, weight loss and malnutrition. Hyperemesis has a significant physical and psychosocial impact on patients and leads to overall higher rates of fetal loss, preeclampsia, preterm birth, low birth weight and fetal malnutrition. Hyperemesis is the second leading cause of hospitalization in pregnancy (second to preterm labor) and typically recurs in subsequent pregnancies. There are currently no FDA-approved therapies for this condition. Research published by an international team that included Marlena Fejzo, Ph.D., Clinical Assistant Professor of Population and Public Health Sciences in the Center for Genetic Epidemiology at the University of Southern California, and Sir Stephen O'Rahilly, M.D. FRS FMedSci, Professor of Clinical Biochemistry and Medicine at the University of Cambridge, found that GDF15 levels increase steadily in early pregnancy and are higher in women who experience nausea and vomiting in pregnancy and hyperemesis. The research uncovered that women with GDF15 genetic variants associated with lower levels of GDF15 in a non-pregnant state are predisposed to hyperemesis. NGM120, a GFRAL antagonist antibody, is designed to block GDF15 signaling and, thereby, may have therapeutic benefit for treating patients suffering from hyperemesis. Dr. Fejzo, who experienced hyperemesis in her own pregnancies and subsequently dedicated her professional life to uncovering the biology underpinning the condition, is serving as an advisor to NGM Bio. Key 2023 Highlights Solid Tumor Oncology Continued enrollment in a Phase 1 Part 1b cohort of the ongoing Phase 1/2 trial evaluating NGM707 in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors. This cohort is anticipated to complete enrollment in the first half of 2024. Completed enrollment in Phase 1 Part 1b cohorts of Phase 1/1b trials evaluating NGM831 and NGM438, respectively, in combination with pembrolizumab in patients with solid tumors. NGM831 is an ILT3 antagonist antibody product candidate, and NGM438 is a LAIR1 antagonist antibody product candidate. Initiated an ongoing Phase 1 Part 1c dose finding cohort evaluating the triplet combination of NGM831, NGM438 and pembrolizumab. This cohort is anticipated to complete enrollment in the first half of 2024. Completed a Phase 2 randomized, single-blind (investigator-blinded), placebo-controlled, multi-center expansion trial of NGM120 in combination with gemcitabine and Nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer (referred to as the PINNACLES trial). NGM120 was well tolerated in the trial. A clear signal of response was not detected, and further development of NGM120 in oncology has been paused. Liver and Metabolic Diseases Presented positive, comprehensive results from the Phase 2b ALPINE 4 trial of aldafermin in patients with compensated cirrhosis (liver fibrosis stage 4 or F4) due to NASH at AASLD The Liver Meeting® in November 2023. ALPINE 4 met its primary endpoint, with aldafermin 3 mg demonstrating a statistically significant reduction in ELF score compared to placebo at 48 weeks of treatment. Although ALPINE 4 was not statistically powered for the secondary endpoint of histological fibrosis improvement of ≥1-stage (NASH Clinical Research Network, or CRN, criteria), a dose-dependent trend in fibrosis improvement was observed. Announced positive data from a Phase 2 investigator-sponsored trial of aldafermin for the treatment of patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and bile acid malabsorption (BAM) in May 2023 at Digestive Disease Week 2023. Aldafermin demonstrated statistically significant reductions in serum 7αC4 (a marker of bile acid synthesis) and fecal bile acids versus placebo in patients with idiopathic BAM with IBS-D. Key 2024 Priorities and Anticipated Milestones Complete enrollment in the Phase 1 Part 1b cohort evaluating the combination of NGM707 and pembrolizumab; provide an update in mid-2024. Continue discussions with the FDA on the design of a potential registrational trial of aldafermin for the treatment of PSC and provide an update in the first half of 2024; plan to initiate enrollment by the end of 2024, contingent upon reaching agreement with the FDA on trial design and additional capital availability. Plan to initiate a reproductive toxicology study of NGM120 for the treatment of hyperemesis in 2024, subject to ongoing discussions with the FDA. Continue exploring partnering opportunities across the full NGM Bio product candidate and research portfolio. NGM Bio may further develop other product candidates in its pipeline, pending partnering and/or the availability of additional capital. NGM Bio plans to post an updated corporate presentation on the Investor Relations section of NGM Bio’s website at . About NGM Bio NGM Bio is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. NGM Bio’s biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates and enable their rapid advancement into proof-of-concept studies. All therapeutic candidates in the NGM Bio pipeline have been generated by its in-house discovery engine, always led by biology and motivated by unmet patient need. Visit us at for more information. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA Abbreviations (in Alphabetical Order) F4=Fibrosis stage 4; ILT2=Immunoglobin-Like Transcript 2; ILT3=Immunoglobin-Like Transcript 3; ILT4=Immunoglobin-Like Transcript 4; LAIR1=Leukocyte-Associated Immunoglobulin-Like Receptor 1; MSS=Microsatellite stable; NASH=nonalcoholic steatohepatitis Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “support”, “aims,” “anticipates,” “believe,” “may,” “plans,” “potential,” “promising,” “proposed” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to: NGM Bio’s evolved strategy for aldafermin and NGM120 and focus on rare conditions with unmet needs, and NGM Bio’s belief that this strategy has the greatest potential to deliver nearer-term impact and value creation; discussions with the FDA regarding the design of a potential registrational trial of aldafermin in PSC, including the proposed use of surrogate endpoints for potential accelerated approval; NGM Bio’s belief that the large body of clinical data supports aldafermin’s differentiated potential to address the bile acid dysregulation underpinning PSC; the potential of aldafermin as an engineered FGF19 analog to address the bile acid dysregulation underpinning PSC; the potential of biomarkers of fibrosis, like ELF, to predict clinical outcome in patients with PSC; the potential of NGM120 to treat hyperemesis; NGM Bio’s potential exploration of NGM120 in a planned proof-of-concept study for the treatment of hyperemesis, including ongoing discussions with the FDA on an acceptable toxicology package; the therapeutic potential of, potential indications for and/or planned and continued development of the product candidates in NGM Bio’s pipeline, including NGM707, aldafermin, NGM120, NGM831 and NGM438; the planned timing of initiation, enrollment, data readouts and results of NGM Bio’s clinical trials; NGM Bio’s continued pipeline development, including identification and engagement of third-party partners for potential future business development arrangements (“BD Arrangements”) to determine further development of programs across the full NGM Bio product candidate and research portfolio; and other statements that are not historical fact. Because such statements deal with future events and are based on NGM Bio’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of NGM Bio could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with: the shift in NGM Bio’s strategy and investor perception thereof; the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to failure or delays in successfully initiating, enrolling, reporting data from or completing clinical studies, as well as the risks that results obtained in preclinical or clinical trials to date may not be indicative of results obtained in future trials and that interim topline and preliminary results of clinical trials may change as more participant data becomes available and are subject to audit and verification procedures, which could result in material changes in the final data and such interim topline and preliminary results may not be predictive of final results or results obtained in future trials; the lack of regulatory clarity regarding acceptable surrogate endpoints for PSC and related development uncertainty; the vulnerable patient population experiencing hyperemesis and risks associated with clinical trials on such patient population; uncertainties inherent in the preclinical development process of NGM120 in hyperemesis, including that NGM120 in hyperemesis may never reach clinical development; NGM Bio’s ability to identify, attract and engage third-party partners for BD Arrangements; the time-consuming and uncertain regulatory approval process; NGM Bio’s reliance on third-party manufacturers for its product candidates and the risks inherent in manufacturing and testing pharmaceutical products; the sufficiency of NGM Bio’s cash resources and anticipated cash runway, including the risk that NGM Bio could utilize its available capital resources sooner than it currently expects, and its need for additional capital to pursue further development of its product candidates, including the additional capital necessary for NGM Bio to pursue further development of aldafermin in PSC and NGM120 in hyperemesis; macroeconomic conditions (such as the impacts of global geopolitical conflict, global economic slowdown, increased inflation, high interest rates and recent and potential future bank failures); and other risks and uncertainties affecting NGM Bio and its development programs, including those discussed in the section titled “Risk Factors” in NGM Bio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 filed with the United States Securities and Exchange Commission (“SEC”) on November 2, 2023 and future filings and reports that NGM Bio makes from time to time with the SEC. Except as required by law, NGM Bio assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements. Investor Contact: Media Contact: ir@ngmbio.com media@ngmbio.com

New Brunswick, N.J., (November 7, 2023) – The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced today the submission of a Type II Variation application to the European Medicines Agency (EMA) for the Company’s medicine SIRTURO® (bedaquiline). A supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) was also submitted in August 2023. SIRTURO® is indicated in adults and pediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) as part of combination therapy of pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis. The approved indication may vary per country.i,ii These submissions reflect the Company’s longstanding commitment to patients affected by multidrug-resistant TB (MDR-TB), one of the world’s most significant global health challenges.The applications include data from the Phase 3 STREAM Stage 2 study (NCT02409290), which is a Post-Marketing Requirement in the U.S., a Specific Obligation in the EU and a Post-Marketing Commitment in several other countries. STREAM Stage 2 is the first large-scale, randomized, multi-country clinical study to evaluate the efficacy and safety of an all-oral bedaquiline-containing regimen for MDR-TB. The study compared an all-oral, nine-month bedaquiline-containing regimen to the control regimen of a nine-month injectable-based regimen for the treatment of MDR-TB. The results were published in The Lancet in November 2022.iiiSIRTURO®, a product of Janssen Pharmaceutica NV, part of the Janssen Pharmaceutical Companies of Johnson & Johnson, was first granted accelerated approval by the FDA in December 2012 and conditional approval by the EMA in March 2014 following positive Phase 2 study data.iv,v If approved, these new applications will support the traditional approval in the U.S. and full approval in the European Union.Johnson & Johnson’s Commitment in the Fight Against TBThe traditional/full approval of SIRTURO® would mark the latest milestone in Johnson & Johnson’s efforts to make the medicine available to people with MDR-TB around the world.When Johnson & Johnson introduced SIRTURO®, it was the first targeted medicine for TB with a novel mechanism of action to be introduced in over 40 years. Today, it is a core component of World Health Organization-recommended treatment guidelines for drug-resistant TB, and three of every four MDR-TB patients on treatment are receiving a bedaquiline-containing regimen. To date, more than 700,000 courses of the medicine have been delivered to 159 countries around the world, including the 30 countries with the highest burdens of TB.Earlier this year, Johnson & Johnson granted the Stop TB Partnership's Global Drug Facility (GDF) a license that enabled GDF to tender, procure and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries. In September 2023, the Company confirmed its intent not to enforce patents it owns and controls for SIRTURO® in 134 low- and middle-income countries, building on two decades of collaborative work in the fight against TB.In collaboration with many others, the Company has spent the past decade, since introducing its medicine, investing in critical TB systems capacity, such as healthcare professional training, resistance testing and surveillance, and supply chain security, to help ensure the medicine is accessible, while not compromising its effectiveness as drug resistance increases globally.To learn more about Johnson & Johnson’s efforts in the fight against TB, visit www.jnj.com/TB.About SIRTURO®EUFor a full list of adverse events and information on dosage and administration, contraindications and other precautions when using bedaquiline please refer to the Summary of Product Characteristics.▼In line with EMA regulations for new medicines and those given conditional approval, bedaquiline is subject to additional monitoring.USSIRTURO® (bedaquiline) is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary MDR-TB. Reserve SIRTURO® for use when an effective treatment regimen cannot otherwise be provided.This indication is approved under accelerated approval based on time to sputum culture conversion. Continued approval for this indication has been submitted for approval.Limitations of UseDo not use SIRTURO for the treatment of latent, extrapulmonary or drug-sensitive tuberculosis or for the treatment of infections caused by non-tuberculous mycobacteria. Safety and efficacy of SIRTURO in HIV-infected patients with MDR-TB have not been established, as clinical data are limited.IMPORTANT SAFETY INFORMATIONBOXED WARNINGS: INCREASED MORTALITY AND QT PROLONGATIONINCREASED MORTALITYQT PROLONGATIONWarnings and PrecautionsIncreased Mortality: An increased risk of death was seen in the SIRTURO® treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in one placebo-controlled trial in adults (based on the 120 week visit window). One death occurred during the 24 weeks of administration of SIRTURO®. The imbalance in deaths is unexplained. No discernible pattern between death and sputum culture conversion, relapse, sensitivity to other drugs used to treat tuberculosis, HIV status, or severity of disease could be observed. Only use SIRTURO® in patients 5 years of age and older when an effective treatment regimen cannot otherwise be provided.QT Prolongation: SIRTURO® prolongs the QT interval. Obtain an ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment with SIRTURO®. Obtain serum potassium, calcium, and magnesium at baseline and correct if abnormal. Monitor electrolytes if QT prolongation is detected. SIRTURO® has not been studied in patients with ventricular arrhythmias or recent myocardial infarction.The following may increase the risk for QT prolongation when patients are receiving SIRTURO®: use with other QT prolonging drugs including fluoroquinolones and macrolide antibacterial drugs and the antimycobacterial drug, clofazimine; a history of Torsade de Pointes; a history of congenital long QT syndrome; a history of or ongoing hypothyroidism; a history of or ongoing bradyarrhythmias; a history of uncompensated heart failure; serum calcium, magnesium, or potassium levels below the lower limits of normal.If necessary, bedaquiline treatment initiation could be considered in these patients after a favorable benefit risk assessment and with frequent ECG monitoring.Discontinue SIRTURO® and all other QT prolonging drugs if the patient develops clinically significant ventricular arrhythmia or a QTcF interval of greater than 500 ms (confirmed by repeat ECG).If syncope occurs, obtain an ECG to detect QT prolongation.Risk of Development of Resistance to Bedaquiline: A potential for development of resistance to bedaquiline in Mycobacterium tuberculosis exists. Bedaquiline must only be used in an appropriate combination regimen for the treatment of pulmonary MDR-TB to reduce the risk of development of resistance to bedaquiline.Hepatotoxicity: In clinical trials, more hepatic-related adverse reactions were reported in adults with the use of SIRTURO® plus other drugs to treat tuberculosis compared to other drugs used to treat tuberculosis without the addition of SIRTURO®. Alcohol and other hepatotoxic drugs should be avoided while on SIRTURO®, especially in patients with impaired hepatic function. Hepatic-related adverse reactions have also been reported in pediatric patients 5 years of age and older.Monitor symptoms (such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, and hepatomegaly) and laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin) at baseline, monthly while on treatment, and as needed. Test for viral hepatitis and discontinue other hepatotoxic medications if evidence of new or worsening liver dysfunction occurs. Discontinue SIRTURO® if:Drug InteractionsCYP3A4 Inducers/Inhibitors: Bedaquiline is metabolized by CYP3A4 and its systemic exposure and therapeutic effect may therefore be reduced during co-administration with inducers of CYP3A4. Avoid co-administration of strong CYP3A4 inducers such as rifamycins (ie, rifampin, rifapentine, and rifabutin) or moderate CYP3A4 inducers such as efavirenz, during treatment with SIRTURO®. Co-administration of SIRTURO® with strong CYP3A4 inhibitors may increase the systemic exposure to bedaquiline, which could potentially increase the risk of adverse reactions. Therefore, avoid the use of strong CYP3A4 inhibitors used for more than 14 consecutive days while on SIRTURO®, unless the benefit of treatment with the drug combination outweighs the risk. Appropriate clinical monitoring for SIRTURO®-related adverse reactions is recommended.Use in Specific PopulationsPregnancyRisk Summary: Available data from published literature of SIRTURO® use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks associated with active tuberculosis during pregnancy. Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due to oral administration of bedaquiline to pregnant rats and rabbits during organogenesis at exposures up to 6 times the clinical dose based on AUC comparisons.Clinical Considerations: Disease-associated Maternal and/or Embryo/Fetal Risk Active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including maternal anemia, caesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death.LactationRisk Summary: Data from a published clinical lactation study demonstrate higher bedaquiline concentrations in breast milk compared to maternal plasma, suggesting that bedaquiline accumulates in breast milk (see Data). Data are insufficient to determine effects of the drug on the breastfed infants. No data are available on the effects of the drug on milk production. Because of the potential for serious adverse reactions in a breastfed infant, including hepatotoxicity, advise patients that breastfeeding is not recommended during treatment with SIRTURO and for 27.5 months (5 times the half-life) after the last dose unless infant formula is not available.Clinical Considerations: If an infant is exposed to bedaquiline through breast milk, monitor for signs of bedaquiline-related adverse reactions, such as hepatotoxicity [see Adverse Reactions (6)].Data: A clinical lactation study was conducted in two lactating women who were approximately 7 weeks’ postpartum. Bedaquiline and M2, its active metabolite, levels were measured between approximately 27 and 48 hours after the last bedaquiline dose, and concentrations of bedaquiline and M2 ranged from 2.61 to 8.11 mg/L and 0.27 to 0.81 mg/L, respectively. The milk:plasma ratios for bedaquiline and M2 at 27 to 48 hours after the last dose of bedaquiline ranged from approximately 19 to 29 and 4 to 6, respectively.Pediatric Use: The safety, effectiveness and dosage of SIRTURO® in pediatric patients less than 5 years of age and/or weighing less than 15 kg have not been established.Renal Impairment: SIRTURO® has mainly been studied in adult patients with normal renal function. Renal excretion of unchanged bedaquiline is not substantial (less than or equal to 0.001%). No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment or end stage renal disease requiring hemodialysis or peritoneal dialysis, SIRTURO® should be used with caution. Monitor adult and pediatric patients for adverse reactions of SIRTURO® when administered to patients with severe renal impairment or end stage renal disease requiring hemodialysis or peritoneal dialysis.Adverse ReactionsAdult: Adverse reactions that occurred more frequently than placebo during treatment with SIRTURO® included: nausea (38% vs 32%), arthralgia (33% vs 22%), headache (28% vs 12%), hemoptysis (18% vs 11%), chest pain (11% vs 7%), anorexia (9% vs 4%), transaminases increased (9% vs 1%), rash (8% vs 4%), and blood amylase increased (3% vs 1%).Pediatric: The safety assessment of bedaquiline is based on the Week 24 analysis from 30 pediatric patients in an ongoing, single-arm, open-label, multi-cohort trial, (Study 4).Pediatric Patients (12 years to less than 18 years of age): The first cohort was designed to enroll patients 12 years to less than 18 years of age (fifteen patients 14 years to less than 18 years of age were enrolled) with confirmed or probable pulmonary MDR-TB infection who received SIRTURO® (400 mg once daily for the first 2 weeks and 200 mg 3 times/week for the following 22 weeks) in combination with a background regimen.The most common adverse reactions were arthralgia in 6/15 (40%) patients, nausea in 2/15 (13%) patients, and abdominal pain in 2/15 (13%) patients. Among the 15 patients, no deaths occurred during treatment with SIRTURO®. Observed laboratory abnormalities were comparable to those in adults.Pediatric Patients (5 years to less than 12 years of age): The second cohort was designed to enroll patients 5 years to less than 12 years of age (fifteen patients aged 5 years to less than 11 years of age were enrolled) with confirmed or probable pulmonary MDR-TB infection who received SIRTURO® (200 mg once daily for the first 2 weeks and 100 mg 3 times/week for the following 22 weeks) in combination with a background regimen.The most common adverse reactions were related to elevations in liver enzymes (5/15, 33%), and led to discontinuation of SIRTURO® in three patients. Elevations in liver enzymes were reversible upon discontinuation of SIRTURO® and some of the background regimen drugs. Among these 15 pediatric patients, no deaths occurred during treatment with SIRTURO®.Please read full Prescribing Information, including Boxed Warnings and Medication Guide for more details.About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we are creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.Learn more at www.jannsen.com. Follow us at @JNJInnovMed and @JanssenUS. Janssen Pharmaceutical NV, Inc. and EU Janssen-Cilag International NV are Johnson & Johnson companies.About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Cautions Concerning Forward-Looking StatementsThis press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements as they are based on current expectations of future events. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from current expectations and projections of Janssen Pharmaceutica NV, EU Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Pharmaceutica NV, EU Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.ReferencesiEuropean Medicines Agency. SIRTURO Summary of Product Characteristics. May 2023. Available at: SIRTURO, INN- bedaquiline (europa.eu). Accessed: November 2023.iihttps://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204384s017lbl.pdfiiiGoodall, Ruth LAdilaa, Oyunchimeg et al. “Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial.” The Lancet, Volume 400, Issue 10366, 1858 – 1868. Available at: https://www-thelancet-com.libproxy1.nus.edu.sg/journals/lancet/article/PIIS0140-6736(22)02078-5/fulltext.ivhttps://www.jnj.com/media-center/press-releases/fda-grants-accelerated-approval-for-sirturo-bedaquiline-as-part-of-combination-therapy-to-treat-adults-with-pulmonary-multi-drug-resistant-tuberculosisvhttps://www.jnj.com/media-center/press-releases/sirturo-bedaquiline-receives-conditional-approval-in-the-european-union-for-the-treatment-of-multi-drug-resistant-tuberculosis