Simcere Zaiming Pharmaceutical Co., Ltd.

Reported two positive readouts for rademikibart, the Company’s lead asset, from the Global Phase 2b trial in moderate-to-severe persistent asthma and from the China pivotal trial in moderate-to-severe atopic dermatitis (AD) Type C meeting in AD and End-of-Phase 2 (EoP2) meeting in asthma have been scheduled with the U.S. Food and Drug Administration (FDA) in Q2 2024 to discuss trial results and proposed registrational programs Granted Simcere the exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China. Simcere is actively engaged with China’s Center for Drug Evaluation (CDE) regarding the potential NDA filing for marketing approval in China for treatment with rademikibart in patients with AD Cash, cash equivalents and short-term investments of $118.7 million expected to support planned operations into at least 2026 SAN DIEGO, CA and TAICANG, China, April 16, 2024 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma,” “Connect” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today reported financial results for the year ended December 31, 2023, and provided a business update. “2023 marked an achievement-filled year for Connect highlighted by two positive readouts with our lead asset rademikibart from the global Phase 2b trial in asthma and the pivotal trial in China in AD. The clinical data we shared from these two trials demonstrated the potential for fast onset of relief, impressive maintenance effect and strong durable efficacy, even with every 4 weeks dosing, and no significant safety concerns. Taken together, the results further underscore rademikibart’s best-in-biologics potential,” said Zheng Wei, Ph.D., Co-Founder and Chief Executive Officer of Connect Biopharma. “Connect is well positioned for another important year in 2024, as we look forward to the scheduled meetings with the FDA to discuss rademikibart registrational programs in AD and asthma in the second quarter of 2024.” Full Year 2023 and Recent Highlights Clinical Programs Highlights Rademikibart Program Reported positive topline data in the Global Phase 2b trial in adult patients with moderate-to-severe asthma in December 2023. The trial met its primary endpoint showing both doses of rademikibart treatment significantly improved lung function at Week 12. Moreover, the improvement in lung function was seen as early as Week 1 and was sustained through Week 24 with both doses. Significant improvements were also observed in asthma control symptoms early and were sustained through Week 24. Rademikibart was generally well tolerated with no unexpected safety signals. Announced positive long-term data from the China pivotal trial in patients with moderate-to-severe AD in November 2023. Clinical response (IGA0/1 and EASI-75) achieved at Week 16 (Stage 1) with rademikibart treatment was maintained through Week 52 (Stage 2) with both every two weeks (Q2W) and every four weeks (Q4W) dosing regimens, with about 90% of the patients on Q4W dose maintaining both IGA0/1 and EASI-75 through Week 52. Additionally, the percentage of patients achieving IGA 0/1 and EASI-75 continued to increase over the 36 weeks of Stage 2 of the study. Rademikibart continued to be well tolerated over 52 weeks of treatment. Icanbelimod Program Reported positive long-term data from the maintenance period through Week 48 of CN002 phase 2 icanbelimod trial in patients with moderate-to-severe ulcerative colitis (UC) in June 2023. Icanbelimod demonstrated sustained clinical remission through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period. There were no new safety signals in the maintenance period and icanbelimod continued to be well-tolerated, consistent with the observed safety data in the induction period. Publications Silverberg JI, et al. Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). J Allergy Clin Immunol. 2024 Apr;153(4):1040-1049.e12. Wang J, et al. Rademikibart (CBP-201), a next-generation monoclonal antibody targeting human IL-4Rα: Two phase I randomized trials, in healthy individuals and patients with atopic dermatitis. Clin Transl Sci. 2023 Dec;16(12):2614-2627. Silverberg JI, et al. A Mini Review of the Impact of Baseline Disease Severity on Clinical Outcomes: Should We Compare Atopic Dermatitis Clinical Trials?Dermatol Ther (Heidelb). 2023 Dec;13(12):3019-3029. Zhang L, et al. Preclinical immunological characterization of rademikibart (CBP-201), a next-generation human monoclonal antibody targeting IL-4Rα, for the treatment of Th2 inflammatory diseases. Sci Rep. 2023 Jul 31;13(1):12411. Presentations Poster presentation at the 2023 Advances in Inflammatory Bowel Diseases Meeting in December 2023 on the Phase 2 trial of icanbelimod showing that patients with UC would likely derive greater clinical benefit with higher doses than icanbelimod 0.2 mg QD, the maximum administered in this Phase 2 dose-ranging trial, which will thus be investigated in the Phase 3 trial program. Four posters at the 2023 World Congress of Dermatology in July 2023 on data from the initial 16-week treatment period with rademikibart of the pivotal trial in China in patients with moderate-to-severe AD. The posters provided detailed and new information on the achievement of primary and secondary endpoints, and highlighted that consistent improvements were observed in both investigator-rated outcomes and patient reported outcomes. Poster presentation at the 2023 Revolutionizing Atopic Dermatitis (RAD) Annual Meeting in April 2023 on the meaningful improvements observed in patients with either moderate or severe AD with 16 weeks of rademikibart treatment at either two- or four-week dosing from the global Phase 2 trial in AD. Late breaking oral presentation and an e-poster with an oral presentation on rademikibart clinical development program in patients with moderate-to-severe AD at the American Academy of Dermatology (AAD) Annual Meeting in March 2023. Data presented showed that patients treated with rademikibart were observed to demonstrate rapid and sustained improvements at Week 16 in the primary population from the China pivotal trial and show rapid and sustained improvement across all body regions in a post-hoc analyses from the Global Phase 2b trial. Given the highly compelling therapeutic potential observed with rademikibart in multiple therapeutic areas, the Company announced the strategic prioritization of rademikibart development program to further support near-term and long-term value drivers. To maximize resources and extend its cash runway, the Company has decided to terminate, effective May 2024, the in-license agreement for CBP-174 with Pfizer (originally licensed from Arena Pharmaceuticals) and postpone the advancement of all pre-clinical and discovery programs. The Company’s overall partnership strategy remains unchanged and the Company will continue to actively seek a development and commercialization partner for rademikibart and development partner for icanbelimod at a global or a regional level. Corporate Development Highlights Signed an exclusive licensing and collaboration agreement with Simcere in November 2023. The agreement granted Simcere the exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, while Connect retains all the rights to develop and commercialize rademikibart in all other markets. As part of the agreement, the Company received a ¥150 million ($21 million) upfront payment and will receive up to ¥875 million ($120 million) upon achieving certain development and commercial milestones, in addition to royalties up to low double-digit percentages of net sales. Appointed James Zuie-chin Huang, M.B.A., a successful entrepreneur, investor, and key opinion leader in the healthcare sector, in February 2024 to the Company’s Board of Directors. Anticipated Upcoming Milestones The Company has scheduled two meetings with the FDA in Q2 2024, including a Type C meeting to discuss the potential U.S. registrational path for rademikibart in AD, followed by an EoP2 meeting to discuss a U.S. registrational program for rademikibart in asthma. Simcere, Connect’s partner in Greater China who holds responsibility for future development, including for additional indications and NDA submission, is progressing its regulatory discussion with China’s CDE ahead of a planned NDA filing for rademikibart for patients with AD. Connect expects to receive an update from Simcere as early as Q2 2024 on these next steps. 2023 Financial Results Cash, cash equivalents and short-term investments were $118.7 million as of December 31, 2023, compared with $161.9 million on December 31, 2022. The $43.2 million decrease was mainly due to cash used to advance the Company’s clinical programs and fund its operations, offset by the upfront partnership payment received from Simcere. Based on its current operating plans, management believes the Company has sufficient cash and investments to support planned operations into at least 2026. R&D expenses for the year ended December 31, 2023, totaled $51.9 million, compared with $96.6 million for the year ended December 31, 2022, a decrease of $44.7 million primarily due to fewer clinical trials, less drug product manufacturing activity, and lower personnel costs due to fewer research and development headcount compared to prior year. Administrative expenses totaled $14.5 million for the year ended December 31, 2023, compared with $20.8 million for the year ended December 31, 2022. The decrease in administrative expenses was primarily due to lower professional fees, including accounting, insurance, legal, and other consulting costs, and lower share-based compensation expense compared to the prior year. Net loss totaled $59.5 million for the year ended December 31, 2023, compared with a net loss of $118.1 million for the year ended December 31, 2022. Connect Biopharma Holdings Ltd. Condensed Consolidated Statements of Loss For the Year Ended December 31, (in USD thousands) 2022 2023 Research and development expenses $ (96,630) $ (51,913) Administrative expenses (20,806) (14,515) Net impairment losses (4,698) - Other income 929 1,580 Other (losses)/gains - net 1,889 2,774 Operating loss (119,316) (62,074) Finance income 1,544 2,714 Finance cost (21) (23) Finance income – net 1,523 2,691 Net loss before income tax (117,793) (59,383) Income tax expense (298) (120) Net loss $ (118,091) $ (59,503) Net loss attributable to： Owners of the Company $ (118,091) $ (59,503) Net loss per share Basic and diluted $ (2.15) $ (1.08) Connect Biopharma Holdings Ltd. Selected Consolidated Balance Sheet Data December 31, (in USD thousands) 2022 2023 Cash, cash equivalents, short-term and long-term investments $ 161,857 $ 118,653 Total assets 174,013 125,892 Total liabilities 16,521 24,849 Accumulated losses (479,844) (539,347) Total shareholders' equity 157,492 101,043 About Connect Biopharma Holdings Limited Connect Biopharma is a global, clinical-stage biopharmaceutical company applying its expertise in T cell biology and deep knowledge of the drug discovery industry to develop innovative therapies to treat chronic inflammatory diseases with the goal of improving the lives of millions of those affected around the world. The Company is building a rich pipeline of proprietary small molecules and antibodies, using functional T cell assays, to screen and discover potent product candidates against validated immune targets. The Company’s lead product candidate, rademikibart (formerly known as CBP-201), is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) in development for the treatment of atopic dermatitis (AD) and asthma. The Company’s second product candidate, icanbelimod (formerly known as CBP-307), is a modulator of S1P1 T cell receptors and is in development for the treatment of ulcerative colitis (UC). For more information, please visit: Forward-Looking Statements Connect Biopharma cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may”, “could”, “will”, “would”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, “intend”, “predict”, “seek”, “contemplate”, “look forward”, “potential”, “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s plans to advance the development of its product candidates, the timing of achieving any development, regulatory or commercial milestones or reporting data or whether such milestones or data will be achieved or generated, including whether any new drug application will be submitted or accepted and the timing thereof, and the potential of such product candidates, including to achieve any benefit, improvement, differentiation, trend or pro any product approval or be effective, the Company’s ability to identify and enter into any strategic partnership, whether the Company’s Greater China partnership will meet expectations, and the sufficiency of the Company’s cash and investments to support planned operations. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its plans will be achieved. Actual data may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on April 11, 2023, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Connect Biopharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Connect Biopharma’s filings with the SEC which are available from the SEC’s website ( ) and on Connect Biopharma’s website ( ) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. INVESTOR CONTACT: Tim McCarthy LifeSci Advisors tim@lifesciadvisors.com

- Achieved $46.3 Million in Net Revenue from Sales of COSELA® (trilaciclib) for Full Year 2023, Representing 48% Growth Over 2022; Provided 2024 Net COSELA Revenue Guidance of $60 to $70 Million - - Net COSELA Revenue Grew 29% in the Fourth Quarter of 2023 to $13.9 Million - - Announced That Final Analysis of Phase 3 PRESERVE 2 Trial Evaluating Overall Survival in Metastatic Triple Negative Breast Cancer is Estimated to Occur in the Third Quarter of 2024 - - Presented New Analyses Indicating that Patients Who Previously Received Trilaciclib in a Clinical Trial Setting Experienced Improved Overall Survival with Subsequent Anticancer Therapies - - Provided Initial Results from Phase 2 Trial in Combination with a TROP2 Antibody-Drug Conjugate Indicating Improvements in Overall Survival for Patients Receiving Trilaciclib - - Management to Host Webcast and Conference Call today at 8:30 AM ET - RESEARCH TRIANGLE PARK, N.C., Feb. 28, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today provided a corporate and financial update for the fourth quarter and full year ended December 31, 2023. “The strong fourth quarter 2023 vial volume growth of COSELA, which has continued through the beginning of 2024, highlights not only the importance of this unique drug to oncologists treating people living with extensive-stage small cell lung cancer, but also the significant addressable market still available to us as we drive continued penetration and growth,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “Looking ahead, our primary clinical focus is on completing our ongoing trials of trilaciclib in metastatic triple negative breast cancer, including our pivotal PRESERVE 2 trial. We remain confident in the potential of trilaciclib in this trial given the robust long term survival benefit observed in prior trials and the increased statistical power for the final analysis. If successful, we would work closely with the U.S. Food and Drug Administration to expeditiously file for label expansion and bring this therapy to patients as quickly as possible." Fourth Quarter 2023 and Recent Highlights Financial Recognized $13.9 Million and $46.3 Million in Net COSELA Revenue for the Fourth Quarter and Full Year 2023: Net COSELA revenue and vial volume grew 29% and 19%, respectively, during the fourth quarter over the third quarter of 2023 despite the impact of a platinum-based chemotherapy shortage. G1 recognized total revenues of $14.9 million and $82.5 million for the fourth quarter and full year of 2023, respectively. Cash Runway Extends into 2025: G1 ended 2023 with cash, cash equivalents, and marketable securities of $82.2 million. Clinical Final Analysis of the Phase 3 PRESERVE 2 Trial in Metastatic Triple Negative Breast Cancer (mTNBC) is Estimated to Occur in the Third Quarter of 2024: G1 announced that the Independent Data Monitoring Committee (DMC) recommended continuation of the Phase 3 PRESERVE 2 trial, evaluating trilaciclib in combination with gemcitabine and carboplatin for 1L treatment of mTNBC, to the final analysis. The DMC did not express any concerns or recommend any other changes to the study. The final analysis will be conducted on the intent-to-treat (ITT) population. G1 remains blinded to all data. (See February 12, 2024 press release here) Initial Efficacy Results from Ongoing Phase 2 Antibody-Drug Conjugate (ADC) Trial Suggest Improved Overall Survival (OS) Among Patients Receiving Trilaciclib in Combination with a TROP2 ADC: The preliminary data provided in January 2024 from the ongoing Phase 2 trial of trilaciclib in combination with the ADC sacituzumab govitecan (SG) in patients with mTNBC patients suggested clinically meaningful improvements in OS among patients receiving trilaciclib in combination with SG compared to SG alone (using historical data from the ASCENT study), including (1) median OS of 17.9 months with trilaciclib versus 12.1 months for SG alone and (2) estimated 12-month survival of 59% of patients receiving trilaciclib in combination with SG, representing a ~20% improvement over SG alone. The Company expects to provide updated OS results from this study mid-2024. (See January 8, 2024 J.P. Morgan update press release here) Medical Presented New Post Hoc Analyses Indicating that Patients Who Previously Received Trilaciclib Experienced Improved OS with Subsequent Anticancer Therapies (SACT): G1 presented new data at the 2023 San Antonio Breast Cancer Symposium (SABCS) from patients with mTNBC who participated in G1’s Phase 2 trial. These data indicate that patients who received trilaciclib with their cytotoxic chemotherapy during the trial and then received SACT after trilaciclib discontinuation exhibit statistically significant and clinically meaningful improvements in median OS (32.7 months versus 12.8 months; p=0.001). Additionally, median OS for patients who received prior trilaciclib was improved from the time they started their first SACT compared to patients who did not receive prior trilaciclib (14.0 months versus 5.8 months; p=0.001). (See December 5, 2023 SABCS press release here) Presented Four Posters During the 2023 ASCO Quality Care Symposium: These provide new real-world evidence indicating that trilaciclib administered prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC) lowers the rate of hospitalization and cytopenia events and may improve survival. (See October 27, 2023 ASCO Quality Care Symposium press release here) COSELA Recommended as a Myeloid Supportive Agent in the Updated ASCO SCLC Guidelines: The SCLC guidelines provide evidence-based recommendations to practicing clinicians on the management of patients with SCLC. (See October 18, 2023 ASCO Guidelines press release here) Fourth Quarter and Full Year 2023 Financial Results As of December 31, 2023, cash, cash equivalents and marketable securities totaled $82.2 million, compared to $145.1 million as of December 31, 2022. Total revenues for the fourth quarter of 2023 were $14.9 million, including $13.9 million in net product sales of COSELA and license revenue of $1.0 million, primarily related to supply and manufacturing services from Simcere and patent and clinical trial costs reimbursed primarily by EQRx and Simcere, compared to $10.3 million in total revenues in the fourth quarter of 2022. Total revenues for the full year 2023 were $82.5 million, including net product revenue of $46.3 million from sales of COSELA and license revenue of $36.2 million, compared to total revenues of $51.3 million in the prior year. Operating expenses for the fourth quarter of 2023 were $23.8 million, compared to $41.1 million for the fourth quarter of 2022. GAAP operating expenses include stock-based compensation expense of $3.2 million for the fourth quarter of 2023, compared to $4.4 million for the fourth quarter of 2022. Operating expenses for the full year 2023 were $122.0 million, compared to $187.5 million for the prior year. Stock-based compensation expense for the full year 2023 was $14.5 million, compared to $20.6 million for the prior year. Cost of goods sold expense for the fourth quarter of 2023 was $1.3 million, compared to $1.0 million for the fourth quarter of 2022, primarily due to an increase in product sales. Cost of goods sold expense for the full year 2023 was $7.2 million, compared to $3.7 million for the prior year. Research and development (R&D) expenses for the fourth quarter of 2023 were $7.4 million, compared to $16.6 million for the fourth quarter of 2022. The decrease in R&D expenses was primarily due to a decrease in the Company's clinical program costs. R&D expenses for the full year 2023 were $43.7 million, compared to $83.3 million for the prior year. Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2023 were $15.2 million, compared to $23.6 million for the fourth quarter of 2022. The decrease in SG&A expenses was primarily due to decreases in commercialization activities, personnel costs, and medical affairs. SG&A expenses for the full year 2023 were $71.1 million, compared to $100.4 million for the prior year. The net loss for the fourth quarter of 2023 was $10.9 million, compared to $33.6 million for the fourth quarter of 2022. Net loss for the full year 2023 was $48.0 million, compared to a net loss of $147.6 million for the prior year. The basic and diluted net loss per share for the fourth quarter of 2023 was $(0.21), compared to $(0.73) for the fourth quarter of 2022. The basic and diluted net loss per share for the full year 2023 was $(0.93) compared to $(3.38) for the prior year. 2024 Financial Guidance G1 today provided full year 2024 financial guidance. The Company expects to generate between $60 million and $70 million in COSELA net revenue in 2024. G1's product revenue guidance is based on expectations for continued acceleration of sales performance of COSELA in the U.S. Additionally, the Company believes that its current cash runway is sufficient to fund its operations into 2025. Webcast and Conference Call G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the fourth quarter and full year ended December 31, 2023. Please note the following process to access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended to join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the Company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event. About COSELA® (trilaciclib) for Injection COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021. Indication COSELA® (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer. Important Safety Information COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity. The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/ To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. About G1 Therapeutics G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1 has a deep clinical pipeline and is executing a development plan evaluating trilaciclib in a variety of solid tumors, including breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn. G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," “could”, “believe,” “goal”, “projections,” "estimate," "intend," “indicate,” “potential,” “opportunity,” “suggest,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those related to the potential of trilaciclib in the Phase 3 PRESERVE 2 trial for reasons including the robust long term survival benefit observed in prior trials and the increased statistical power for the final analysis, are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the Company’s dependence on the commercial success of COSELA (trilaciclib); the development and commercialization of new drug products is highly competitive; the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; chemotherapy shortages and market conditions. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. G1 Therapeutics Contacts: John W. Umstead VChief Financial Officer919-747-8419jumstead@g1therapeutics.com Will RobertsCommunications OfficerVice President, Investor Relations & Corporate Communications919-907-1944 wroberts@g1therapeutics.com G1 Therapeutics, Inc.Balance Sheet Data(in thousands) December 31, 2023 December 31, 2022Cash and cash equivalents and Marketable securities$82,156 $145,070 Working Capital$85,232 $143,912 Total Assets$121,540 $187,965 Accumulated deficit$(779,985) $(732,018)Total stockholders' equity$35,386 $68,747 G1 Therapeutics, Inc.Condensed Statements of Operations(in thousands, except share and per share amounts) Three Months EndedDecember 31, Twelve Months EndedDecember 31, 2023 2022 2023 2022 Revenues(unaudited) Product sales, net$13,922 $8,870 $46,344 $31,337 License revenue 951 1,380 36,167 19,964 Total revenues 14,873 10,250 82,511 51,301 Operating expenses Cost of goods sold 1,256 992 7,195 3,748 Research and development 7,380 16,587 43,711 83,316 Selling, general and administrative 15,166 23,558 71,132 100,415 Total operating expenses 23,802 41,137 122,038 187,479 Loss from operations (8,929) (30,887) (39,527) (136,178)Other income (expense) Interest income 529 478 2,473 748 Interest expense (2,124) (2,996) (10,038) (10,432)Other income (expense) 548 237 2,240 3 Total other income (expense), net (1,047) (2,281) (5,325) (9,681)Loss before income taxes (9,976) (33,168) (44,852) (145,859)Income tax expense 902 481 3,115 1,700 Net loss$(10,878) $(33,649) $(47,967) $(147,559)Net loss per share, basic and diluted$(0.21) $(0.73) $(0.93) $(3.38)Weighted average common shares outstanding, basic and diluted 51,838,834 46,279,808 51,733,487 43,626,113

NANJING, China, Feb. 20, 2024 /PRNewswire/ -- On February 19, 2024, the Journal of American Medical Association•Neurology (JAMA NEUROLOGY, IF: 29.0) published online the key findings of a phase III clinical study (NCT04950920) (the "TASTE-SL Study") investigating Sanbexin® (a combination of edaravone and dexborneol) sublingual tablets for the treatment of acute ischemic stroke (the "AIS"). The findings indicate that Sanbexin® sublingual tablets has substantially enhanced neurological functions and independence in daily living activities among AIS patients following the treatment. Continue Reading JAMA-Neurology paper published online Feb.19 TASTE-SL study design TASTE-SL study primary end point Sanbexin® sublingual tablets is an innovative drug jointly developed by Simcere Pharmaceutical Group Ltd. ("Simcere") and Neurodawn Pharmaceutical Co., Ltd. ("Neurodawn"). The Sanbexin® sublingual tablets is expected to become a sequential therapy with Simcere's marketed Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) and allow patients to receive a complete course of treatment both in and outside of the hospital. On June 28, 2023, the New Drug Application (NDA) of the Sanbexin® sublingual tablets was accepted by the National Medical Products Administration of China (the "NMPA"). The first indication is for the improvement of neurological symptoms, activities of daily living, and functional disabilities caused by AIS. Sanbexin® sublingual tablet offers a novel approach to stroke treatment, leveraging the power of edaravone and dexborneol. The two active ingredients dissolve quickly under the tongue and are rapidly absorbed into the bloodstream via the sublingual venous plexus, providing unparalleled anti-inflammatory and free radical scavenging capabilities. By minimizing the cascading damage caused by AIS and protecting brain cells, this innovative formulation has the potential to expand treatment options and improve patient compliance. With its innovative sublingual delivery system, Sanbexin® is poised to revolutionize stroke care. The TASTE-SL study, published in JAMA Neurology, is a Phase III clinical trial that evaluated the safety and efficacy of Sanbexin® sublingual tablets in AIA patients. This multi-center, randomized, double-blind, placebo-controlled study enrolled 914 AIS patients within 48 hours of onset at 33 research sites in China from June 28, 2021, to August 10, 2022. Of these, 450 patients in the Sanbexin® sublingual tablets group received 36mg dose of sublingual edaravone dexborneol (edaravone 30mg, dexborneol 6mg) twice a day for 14 consecutive days), while 464 patients in the placebo group received a sublingual placebo (edaravone 0mg, dexborneol 60μg) twice a day for 14 consecutive days. The findings from the clinical trial suggest that the Sanbexin® sublingual tablets offer significant benefits for the treatment of AIS. The study, which included 302 patients, showed that those taking Sanbexin® sublingual tablets had a higher proportion of good functional outcomes (mRS score 0-1) on day 90 post-randomization compared to the placebo group: – 64.4% vs. 54.7%. The odds ratio was 1.50 (95% CI 1.15-1.95, p=0.003). Subgroup analyses of different demographic and clinical characteristics revealed consistent improvements in neurological function for the Sanbexin® sublingual tablet, regardless of age (≤65 or >65), gender, time from stroke onset to treatment (≤24 hours or >24 hours), presence of hypertension, hyperlipemia, diabetes, heart disease, or renal dysfunction. The Sanbexin® sublingual tablets demonstrated a favorable safety profile, with comparable rates of adverse events (AEs) and treatment-related AEs within 90 days between the two groups. This data strengthens Sanbexin® sublingual tablets' position as an effective and well-tolerated treatment option for AIS patients. Prof. Wang Yongjun, President of Beijing Tiantan Hospital of Capital Medical University, said, "In the field of stroke treatment, the continued exploration of brain cell protection therapy is beginning to show promise. Following the TASTE study, which validated the clinical benefit of edaravone dexamethasone injection, the TASTE-SL study further confirmed the efficacy and safety of the sublingual dosage form in the AIS population, and a more convenient way of administering the drug is expected to push the brain cell protection to home treatment." Prof. Fan Dongsheng from the Peking University Third Hospital said, "Sanbexin® sublingual tablets is effective in improving neurological function recovery and independent living ability of ischemic stroke patients after treatment and apply to a variety of treatment scenarios. This Phase III study of Sanbexin® sublingual tablet also provides a high-quality evidence-based basis for clinical brain cell protection, which provides a strong guarantee for stroke treatment." SOURCE Simcere Pharmaceutical Group Limited