Shasqi, Inc.

SAN FRANCISCO, April 5, 2024 /PRNewswire/ -- Shasqi, Inc. ("Shasqi"), a biotech company whose mission is to make cancer drugs more effective with click chemistry, today announced it will present five posters on the company's novel tumor-targeted drug activation approach at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, April 5-10, 2024. The posters will describe data generated with Shasqi's CAPAC® (Click Activated Protodrugs Against Cancer) approach. CAPAC uses 2022 Nobel Prize winning technology, click chemistry, to selectively activate high doses of cancer drugs directly at the tumor, minimizing toxicity to healthy cells and potentially improving the therapeutic index by dramatically altering the exposure. This approach overcomes many limitations of antibody-drug conjugates (ADCs). "We are looking forward to sharing new data from the Shasqi pipeline at AACR," said Shasqi Vice President of Research, Travis Biechele, Ph.D. "It is exciting to see data showing that we can effectively activate cancer drugs at the tumor using antigen-bound activators, resulting in sustained tumor regression." Shasqi is advancing a pipeline of assets based on validated targets and payloads. The posters presented at the AACR meeting will show preclinical efficacy and safety data for assets targeting HER2, TROP2, and NECTIN-4, each paired with either an MMAE or exatecan payload. Presentations Abstracts are available and can be viewed on the AACR website. Monday, April 8 between 9 AM - 12:30 PM PST Click chemistry enabled selective activation of highly cytotoxic MMAE payload at tumors using TROP2 targeting agent Lead Author: George Coricor, Ph.D. Poster Section 28, Poster Board: 13 Wednesday, April 10 between 9 AM - 12:30 PM PST Tumor targeted activation of an attenuated exatecan protodrug through Click Chemistry demonstrates efficacy in murine tumor studies Lead Author: Sangeetha Srinivasan, Ph.D. Poster Section 26, Poster Board: 1 A click chemistry-based HER2 targeting agent activates a decoupled MMAE payload making it highly differentiated in efficacy and safety than ADCs Lead Author: Sangeetha Srinivasan, Ph.D. Poster Section 26, Poster Board: 2 Nectin-4 targeted therapy with MMAE protodrug results in anti-tumor efficacy mediated by click chemistry Lead Author: George Coricor, Ph.D. Poster Section 26, Poster Board: 3 Improving anti-tumor efficacy by modulating a separate HER2 activator and an MMAE payload and reuniting both through click chemistry Lead Author: Stefanie Wagner Poster Section 26, Poster Board: 4 About Shasqi and CAPAC® Shasqi's unique CAPAC® (Click Activated Protodrugs Against Cancer) platform uses Nobel Prize winning technology, click chemistry, to selectively activate high doses of cancer drugs directly at the site of the tumor, minimizing toxicity to healthy cells and potentially improving the therapeutic index by dramatically altering the exposure. CAPAC builds on the advances achieved by antibody-drug conjugates (ADCs), changing what's possible with antigen targeted drug activation. Shasqi has developed an expansive and diverse library of antigen targeting activators and cancer therapeutic protodrugs. These two components are decoupled from each other and united at the site of the tumor via a click chemistry reaction. We are the first company to use click chemistry in humans. Shasqi is advancing the development of new tumor targeting activators and protodrugs on an ongoing basis and is in active collaboration with partners in the biopharmaceutical industry to expand the CAPAC library of antigen targeting activators and protodrugs. For more information, please visit: and follow Shasqi on LinkedIn.

SAN FRANCISCO, March 5, 2024 /PRNewswire/ -- Shasqi, Inc. ("Shasqi") a biotech company whose mission is to make cancer drugs more effective with click chemistry, today announced that Founder & Chief Executive Officer José M. Mejía Oneto, MD, PhD, will present at the 14th Annual World ADC Conference in London, United Kingdom on Tuesday March 12th at 11:00am GMT. The session titled "CAPAC: A Modular Platform for Tumor-Targeted Drug Activation Using Click Chemistry In Vivo" will be part of the "Supercharging ADC Efficacy & Conquering Toxicity Through Transformative Emerging Conjugation Technologies" track as part of the 2nd Generation Conjugates Day. "We are honored to be an invited speaker at the 2nd Next-Generation Conjugation Day during World ADC Europe—an event synonymous with innovation." said Dr. Mejía Oneto. "We're excited to share more about our technology and present new data demonstrating how our unique approach has the potential to meaningfully increase the therapeutic index of cancer drugs." As part of the session, Shasqi will share background on its novel Click Activated Protodrugs Against Cancer (CAPAC®) platform, which leverages click chemistry for tumor-targeted drug activation. Shasqi will also share clinical proof-of-concept data and unveil preclinical data from the pipeline, showcasing the ability to use antibody fragments to activate high potency payloads at the tumor. Shasqi has developed a novel approach to activating drugs at the tumor. First, an antigen targeting activator is infused, which binds to the tumor. Then, an inert version of a cancer therapeutic, called a protodrug, is infused. The protodrug finds the activator at the tumor and the active drug is released via a click chemistry reaction. Separation of payload from tumor targeting confers several advantages over antibody-drug conjugates (ADCs) including selective activation at the tumor and the ability to optimize the ratio of each component throughout development, including in the clinic. Together, this allows the therapeutic index of cancer drugs to be maximized. About Shasqi and CAPAC® Shasqi's unique CAPAC® (Click Activated Protodrugs Against Cancer) platform uses Nobel Prize winning technology, click chemistry, to selectively activate high doses of cancer drugs directly at the site of the tumor, minimizing toxicity to healthy cells and potentially improving the therapeutic index by dramatically altering the exposure. CAPAC builds on the advances achieved by antibody-drug conjugates (ADCs), changing what's possible with antigen targeted drug activation. Shasqi has developed an expansive and diverse library of antigen targeting activators and cancer therapeutic protodrugs. These two components are decoupled from each other and united at the site of the tumor via a click chemistry reaction. We are the first company to use click chemistry in humans. Shasqi is advancing the development of new tumor targeting activators and protodrugs on an ongoing basis and is in active collaboration with partners in the biopharmaceutical industry to expand the CAPAC library of antigen targeting activators and protodrugs. For more information, please visit: and follow Shasqi on LinkedIn. SOURCE Shasqi, Inc.

--Jean-Frédéric Viret, Ph.D., has been appointed as Chief Financial Officer effective November 3, 2023-- --Continued to progress myeloid checkpoint solid tumor programs: NGM707, NGM831 and NGM438-- --Selected for an oral plenary presentation of data from Phase 2b ALPINE 4 trial of aldafermin in compensated cirrhosis (F4) due to NASH at upcoming AASLD The Liver Meeting®-- --Reported $166.0 million in cash, cash equivalents and marketable securities as of September 30, 2023, with expected cash runway into mid-2025-- SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc., (NGM Bio) (Nasdaq: NGM), a clinical-stage biotechnology company focused on discovering and developing transformative therapeutics for patients, today reported financial results for the quarterly period ended September 30, 2023 and provided business highlights. “In the third quarter, we continued to advance our efforts to develop novel medicines for cancer and other grievous diseases. This includes steady progress across our clinical-stage solid tumor oncology portfolio,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. “We also announced that comprehensive data from our completed Phase 2b 48-week ALPINE 4 trial of aldafermin in compensated cirrhosis, or F4, patients due to NASH was selected for an oral plenary presentation at the upcoming AASLD The Liver Meeting in November. We are pleased that the ALPINE 4 trial achieved its primary endpoint with positive, statistically significant results across multiple measures, demonstrating clinical impact in this very advanced, difficult-to-treat patient population. This is an important milestone as we seek to partner aldafermin for continued, late-stage development.” Key Third Quarter and Recent Highlights Solid Tumor Oncology In the Phase 1/2 trial evaluating NGM707, an ILT2/ILT4 antagonist antibody product candidate, as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) for the treatment of patients with advanced or metastatic solid tumors, completed enrollment in the Phase 1, Part 1a (monotherapy dose escalation) cohort. Enrollment in the Phase 1, Part 1b (combination dose escalation with pembrolizumab) cohort is ongoing. In the Phase 1/1b trial evaluating NGM438, a LAIR1 antagonist antibody product candidate, as a monotherapy and in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors, completed enrollment in the Phase 1, Part 1a (monotherapy dose escalation) cohort and the Phase 1, Part 1b (combination dose escalation with pembrolizumab) cohort is nearing completion of enrollment. NGM438, alone and in combination with pembrolizumab, has been well-tolerated and there have been no dose limiting toxicities to date. In the Phase 1/1b trial evaluating NGM831, an ILT3 antagonist antibody product candidate, as a monotherapy and in combination with pembrolizumab for the treatment of patients with advanced or metastatic solid tumors, completed enrollment in both a Phase 1, Part 1a and a Phase 1, Part 1b cohort. NGM831, alone and in combination with pembrolizumab, has been well-tolerated and there have been no dose limiting toxicities to date. Aldafermin Upcoming oral plenary presentation of data from Phase 2b ALPINE 4 trial of aldafermin in compensated cirrhosis (F4) due to NASH to be presented at AASLD The Liver Meeting taking place November 10–14, 2023, in Boston, MA. Corporate Jean-Frédéric Viret, Ph.D., has been appointed as Chief Financial Officer (CFO) effective November 3, 2023. Dr. Viret brings a wealth of experience to this role, having previously served for seven years (2014–2021) as CFO of Coherus BioSciences, Inc., a commercial-stage, publicly traded, biopharmaceutical company focused on the research, development and commercialization of biosimilars and biologics to treat cancer, and more recently as CFO of Shasqi, Inc. and Blade Therapeutics, Inc., two privately held biotechnology companies focused on oncology and fibrotic disease, respectively. Earlier in his career, Dr. Viret was CFO at diaDexus, Inc., XDx, Inc. (now CareDx, Inc.) and Anesiva, Inc. and worked in a variety of finance roles at Tularik Inc. and PricewaterhouseCoopers LLP (now PwC). Third Quarter 2023 Financial Results NGM Bio reported a net loss of $28.8 million for the quarter ended September 30, 2023, compared to a net loss of $47.3 million for the same period in 2022. Related party revenue from our collaboration with Merck Sharp & Dohme LLC, or Merck, was $0.6 million for the quarter ended September 30, 2023, compared to $7.9 million for the same period in 2022. Our related party revenue from Merck will continue to decrease in 2023 and we expect minimal funding from Merck from October 1, 2023 through March 31, 2024. Research and development expenses were $22.9 million for the quarter ended September 30, 2023, compared to $46.1 million for the same period in 2022. General and administrative expenses were $8.7 million for the quarter ended September 30, 2023, compared to $10.1 million for the same period in 2022. Cash, cash equivalents and short-term marketable securities were $166.0 million as of September 30, 2023, compared to $271.5 million as of December 31, 2022. NGM Bio expects its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into mid-2025. NGM Bio has based this estimate on plans and assumptions that may prove to be insufficient or inaccurate (for example, with respect to anticipated costs, timing or success of certain activities), and NGM Bio could utilize its available financial resources sooner than it currently expects. 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; ILT2=Immunoglobin-Like Transcript 2; ILT3=Immunoglobin-Like Transcript 3; ILT4=Immunoglobin-Like Transcript 4; LAIR1=Leukocyte-Associated Immunoglobulin-Like Receptor 1; NASH=non-alcoholic 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 “will,” “could,” “expect,” “expected,” “promising,” “aspires,” “aims” 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 (“BD Arrangements”) to determine further development of programs currently without significant resource allocation, including aldafermin, and research and development and discovery engine output; NGM Bio’s expectation of continued decreasing revenue from Merck; the sufficiency of NGM Bio’s cash resources to fund its planned operations into mid-2025; 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; NGM Bio’s reliance on its amended collaboration with Merck; NGM Bio’s ability to identify, attract and engage third-party partners for BD Arrangements, if any, relating to its programs currently without significant resource allocation, including NGM621, aldafermin, NGM313 (MK-3655) and NGM936, or otherwise; 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 the ongoing COVID-19 pandemic, global geopolitical conflict, global economic slowdown, increased inflation, rising 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 June 30, 2023 filed with the United States Securities and Exchange Commission (“SEC”) on August 3, 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 NGM BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Related party revenue $ 582 $ 7,911 $ 4,252 $ 37,152 Operating expenses: Research and development 22,942 46,106 96,150 134,345 General and administrative 8,671 10,109 29,902 30,759 Total operating expenses 31,613 56,215 126,052 165,104 Loss from operations (31,031 ) (48,304 ) (121,800 ) (127,952 ) Interest income, net 2,249 965 7,281 1,684 Other (expense) income, net (15 ) 78 (186 ) 38 Net loss $ (28,797 ) $ (47,261 ) $ (114,705 ) $ (126,230 ) Net loss per share, basic and diluted $ (0.35 ) $ (0.59 ) $ (1.39 ) $ (1.59 ) Weighted average shares used to compute net loss per share, basic and diluted 82,707 80,623 82,393 79,331 NGM BIOPHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share amounts) (Unaudited) September 30, 2023 December 31, 2022* ASSETS Current assets: Cash and cash equivalents $ 51,476 $ 73,456 Short-term marketable securities 114,569 198,036 Related party receivable from collaboration — 7,580 Prepaid expenses and other current assets 7,994 9,787 Restricted cash 2,999 — Total current assets 177,038 288,859 Property and equipment, net 7,281 8,496 Operating lease right-of-use asset 538 2,096 Restricted cash 2,455 3,954 Other non-current assets 4,838 3,997 Total assets $ 192,150 $ 307,402 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 4,690 $ 8,453 Accrued liabilities 16,167 33,638 Operating lease liability, current 1,381 5,385 Contract liabilities 107 366 Total current liabilities 22,345 47,842 Total liabilities 22,345 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 866,138 841,413 Accumulated other comprehensive loss (78 ) (302 ) Accumulated deficit (696,338 ) (581,633 ) Total stockholders' equity 169,805 259,560 Total liabilities and stockholders' equity $ 192,150 $ 307,402 ___________ * Derived from the audited consolidated financial statements.