Chronic phase chronic myeloid leukemia

Interim data from initial dose escalation cohorts from Phase 1 trial of TERN-701 (allosteric BCR-ABL) for treatment of CML expected in second half of 2024 Top-line data from Phase 1 trial of TERN-601 (oral GLP-1) for obesity expected in second half of 2024 Cash, cash equivalents and marketable securities of $263 million, expected to provide runway into 2026 FOSTER CITY, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided corporate updates. “I joined Terns last month at a pivotal stage in the company’s growth as we advance towards initial data readouts from our Phase 1 clinical programs for TERN-601, our oral small molecule GLP-1 agonist for obesity, and TERN-701, our allosteric BCR-ABL inhibitor for CML. Importantly, our global Phase 1 trial of TERN-701 allows for the enrollment of second line CML patients, which makes the study attractive for participants given that there is no allosteric inhibitor currently approved for 2L CML patients,” said Amy Burroughs, chief executive officer of Terns. “Terns made meaningful progress throughout 2023, as highlighted by the initiation of these two clinical programs, the positive Phase 2 data readout from our potentially best in class THR-β and the advances in discovery for our small-molecule GIPR modulators for obesity.” Recent Pipeline Developments and Anticipated Milestones TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML) Global Phase 1 CARDINAL trial initiated in fourth quarter 2023 and is progressing CARDINAL is a global, multicenter, open-label, two-part Phase 1 clinical trial to evaluate the safety, pharmacokinetics (PK) and efficacy of TERN-701 in patients with previously treated CMLThe study design leverages insights from the ongoing Phase 1 trial in China, which support a starting dose that appears safe and clinically active based on emerging early clinical data The CARDINAL trial design provides multiple opportunities to potentially differentiate TERN-701 in the CML treatment landscape Opportunity to efficiently develop TERN-701 as a dose-optimized allosteric inhibitor for CMLInclusion of second-line (2L) chronic phase CML patients, which better positions Terns to potentially move directly into a 2L (or earlier line) pivotal studyReduced competition for trial enrollment as no allosteric inhibitor is currently approved for 2L CML patients Interim data from initial CARDINAL dose escalation cohorts expected in the second half of 2024In March 2024, the United States Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of chronic myeloid leukemiaTerns plans to host a virtual KOL event in mid-2024 to focus on the interpretation of early CML datasets TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity Phase 1 clinical trial of Terns’ lead oral GLP-1 receptor agonist in healthy obese or overweight participants is ongoing Primary endpoints include safety and tolerability assessmentsSecondary and exploratory endpoints include PK and change in body weight over 28 days Top-line data, including 28-day body weight loss, expected in the second half of 2024Terns continues preclinical efforts to identify promising oral, small-molecule combination candidates for obesity (e.g., GLP-1 + THR-β, GLP-1 + GIPR agonist / antagonist) TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist Terns continues to evaluate opportunities for TERN-501 in metabolic diseases Based on non-clinical studies, THR-β is an orthogonal mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight lossNon-clinical data suggests that TERN-501 may augment the weight loss effects of a GLP-1 receptor agonist, as demonstrated in a diet-induced obese mouse model Terns has decided to limit spend in MASH given the current regulatory and clinical development requirements for the indication TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulators Discovery efforts are ongoing for the TERN-800 series of small molecule GIPR modulators for obesityGIPR modulators (agonists and antagonists) have the potential for combination with GLP-1 receptor agonists, such as TERN-601 Corporate Updates In February 2024, Terns announced the appointment of Amy Burroughs as chief executive officer and board member of Terns Fourth Quarter and Full Year 2023 Financial Results Cash Position: As of December 31, 2023, cash, cash equivalents and marketable securities were $263.4 million, as compared with $283.1 million as of December 31, 2022. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026. Research and Development (R&D) Expenses: R&D expenses were $17.5 million and $63.5 million for the quarter and year ended December 31, 2023, respectively, as compared with $10.7 million and $39.6 million for the quarter and year ended December 31, 2022, respectively. General and Administrative (G&A) Expenses: G&A expenses were $6.6 million and $39.1 million for the quarter and year ended December 31, 2023, respectively, as compared with $6.2 million and $22.4 million for the quarter and year ended December 31, 2022, respectively. Net Loss: Net loss was $21.0 million and $90.2 million for the quarter and year ended December 31, 2023, respectively, as compared with $15.8 million and $60.3 million for the quarter and year ended December 31, 2022, respectively. Financial Tables Terns Pharmaceuticals, Inc. Consolidated Statements of Operations (Unaudited; in thousands except share and per share amounts) Quarter Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development $17,459 $10,658 $63,497 $39,617 General and administrative 6,599 6,170 39,061 22,412 Total operating expenses 24,058 16,828 102,558 62,029 Loss from operations (24,058) (16,828) (102,558) (62,029)Interest income 3,333 1,328 12,901 2,110 Other expense, net (245) (4) (314) (68)Loss before income taxes (20,970) (15,504) (89,971) (59,987)Income tax expense (49) (318) (239) (358)Net loss $(21,019) $(15,822) $(90,210) $(60,345) Net loss per share, basic and diluted $(0.29) $(0.29) $(1.27) $(1.67)Weighted average common stock outstanding, basic and diluted 72,333,196 54,696,352 71,259,239 36,033,045 Terns Pharmaceuticals, Inc. Selected Balance Sheet Data (Unaudited; in thousands) December 31, 2023 2022Cash, cash equivalents and marketable securities $263,440 $283,114Total assets 268,517 287,026Total liabilities 13,150 10,083Total stockholders’ equity 255,367 276,943 About Terns PharmaceuticalsTerns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline includes three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator program. For more information, please visit: www.ternspharma.com. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements about the Company within the meaning of the federal securities laws, including those related to expectations, timing and potential results of the clinical trials and other development activities of the Company and its partners; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company’s small-molecule product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the Company’s clinical development plans and activities, including the results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile of its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company’s plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; the Company’s plans and expectations around the addition of key personnel; and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Contacts for Terns InvestorsJustin Nginvestors@ternspharma.com MediaJenna UrbanBerry & Company Public Relationsmedia@ternspharma.com

TERN-701 is an oral allosteric BCR-ABL tyrosine kinase inhibitor (TKI). Image Credit: crystal light / Shutterstock. The US Food and Drug Administration (FDA) has granted an orphan drug designation to Terns Pharmaceuticals’s TERN-701 for the treatment of chronic myeloid leukaemia (CML). The orphan drug status gives sponsors tax credits from clinical trials, exemption from user fees, and a potential seven years of market exclusivity for the therapy after approval. TERN-701 is an oral allosteric BCR-ABL tyrosine kinase inhibitor (TKI) and is one of the two therapies that Terns plans to focus its resources on this year. The treatment is being evaluated in a Phase I CARDINAL trial (NCT06163430) in participants with chronic phase CML who experienced treatment failure on at least one prior second-generation TKI. Interim data from the trial is expected in H2 2024. The other drug, TERN-601, which is being developed as a treatment for obesity, is in a Phase I first-in-human trial, with topline data expected in H2. CML therapies are expected to generate $3.5bn in sales across eight major pharmaceutical markets (the US, France, Germany, Italy, Spain, UK, Japan, and Canada), as per a GlobalData report . The current market leaders in the field include Bristol Myers Squibb ’s Sprycel (dasatinib) and Novartis ’ Tasigna (nilotinib). Sprycel and Tasigna generated $1.4bn and $1.8bn in global sales in 2023, according to the companies’ financials. See Also: Pearl Bio and Merck partner for discovery of cancer therapies Selecta Biosciences files patent for enhanced gene therapy using viral vectors and immunosuppressants GlobalData is the parent company of Pharmaceutical Technology . Earlier this year, Terns paused the development of its most advanced candidate, the oral thyroid hormone receptor-beta (THR-β) agonist, TERN-501, as a treatment for nonalcoholic steatohepatitis (NASH), despite reporting positive data from the Phase IIa DUET trial (NCT05415722). The company cited the current regulatory and developmental MASH landscape for limiting funding for the NASH therapy. Meanwhile, Terns said it plans to evaluate TERN-501, as a combination therapy for obesity. The company also has additional early-stage candidates in the pipeline for obesity. TERN-800, an oral small molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulator, is currently in the discovery stage as an obesity treatment.

Company to pursue eleven indications for IkT-001Pro; all previously approved for treatment with imatinib mesylateBOSTON and ATLANTA, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced preliminary outcomes of the Company’s discussion with the U.S. Food and Drug Administration (FDA) on the path to approval of IkT-001Pro in blood and stomach cancers, the Company’s prodrug of the anticancer agent imatinib mesylate. “With the full meeting minutes from the FDA Review Team in hand, we are confident in our approach as we develop the NDA for IkT-001Pro,” said Dr. Milton Werner, President and Chief Executive Officer of Inhibikase. “Of note, we may not need to complete a formal risk analysis of the possibility of medication errors following discussion of alternative dosage forms with the FDA, but we will have to provide justification for the selected dosage forms to be proposed in the NDA. Further, we are not restricted from use in children nor restricted to just blood cancer-related approved indications. This opens-up the opportunity to seek all 11 approved indications for IkT-001Pro that were previously approved for imatinib mesylate. We are pleased with the discussions we’ve had so far with the FDA and look forward to the work ahead of us needed for the NDA submission.” On February 12, 2024, the FDA Review Team from the Division of Hematologic Malignancies issued final meeting minutes from the pre-NDA video conference that took place January 19, 2024. In the minutes, the FDA noted that it may not be necessary to conduct a formal use-related risk analysis of medication errors due to the Company proposing dosage forms that would not overlap with those of imatinib mesylate. In the NDA package, the Company will have to justify why its alternate dosage forms could overcome the risk of dosing errors by physicians and patients. Following the discussion with the Review Team about possible differences in the way IkT-001Pro and imatinib mesylate are absorbed in the gut, the FDA agreed with the Company’s assertion that a pre-clinical analysis of gut absorption should be performed to determine whether a food effect clinical study is warranted, since the Company’s clinical measures were all performed using an FDA-approved meal prior to taking IkT-001Pro or imatinib mesylate. While the Company will have to supply data and/or rationale for use of IkT-001Pro in any indication for which imatinib mesylate is approved, use in children will need to be accompanied by a statutory planning document related to dose adjustments and use in children of different ages and/or weights. This planning document is required for any product in which use in children is proposed. All other elements of the pre-NDA meeting remain unchanged from those reported on February 7, 2024. The Company continues to explore additional indications for which imatinib delivered by IkT-001Pro could be useful and has an upcoming meeting with the FDA to discuss cardiopulmonary applications of IkT-001Pro in April, 2024. About IkT-001ProIkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, imatinib (marketed as Gleevec®). Imatinib is commonly taken for hematological and gastrointestinal cancers that arise from Abl kinase mutations found in the bone marrow or for gastrointestinal cancers that arise from c-Kit and/or PDGFRa/b mutations in the stomach; c-Kit, PDGFRa/b and Abl are all members of the Abelson Tyrosine Kinase protein family. IkT-001Pro has the potential to be a safer alternative for patients and may improve the number of patients that reach and sustain major and/or complete cytogenetic responses in Stable-Phase Chronic Myelogenous Leukemia (“Stable-Phase CML”) and/or reduce the relapse rate for these patients. In preclinical studies, IkT-001Pro was shown to be as much as 3.4 times safer than imatinib in primates, reducing burdensome gastrointestinal side effects that occur following oral administration. Imatinib delivered as IkT-001Pro was granted Orphan Drug Designation for Stable-Phase CML in September, 2018. About Inhibikase (www.inhibikase.com) Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics for Parkinson's disease and related disorders. Inhibikase's multi-therapeutic pipeline has a primary focus on neurodegeneration and its lead program risvodetinib, an Abelson Tyrosine Kinase (c-Abl) inhibitor, targets the treatment of Parkinson's disease inside and outside the brain as well as other diseases that arise from Ableson Tyrosine Kinases. Its multi-therapeutic pipeline is pursuing Parkinson's-related disorders of the brain and GI tract, orphan indications related to Parkinson's disease such as Multiple System Atrophy, and drug delivery technologies for kinase inhibitors such as IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate that the Company believes will provide a better patient experience with fewer on-dosing side-effects. The Company's RAMP™ medicinal chemistry program has identified a number of follow-on compounds to IkT-148009 to be potentially applied to other cognitive and motor function diseases of the brain. Inhibikase is headquartered in Atlanta, Georgia with an office in Lexington, Massachusetts. Social Media DisclaimerInvestors and others should note that we announce material financial information to our investors using our investor relations website, press releases, SEC filings and public conference calls and webcasts. The Company intends to also use X, Facebook, LinkedIn and YouTube as a means of disclosing information about the Company, its services and other matters and for complying with its disclosure obligations under Regulation FD. Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as "believes," "expects," "may," "will," "should," "anticipates," "plans," or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Inhibikase's current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase's actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to enroll and complete the 201 Trial evaluating risvodetinib in untreated Parkinson’s disease and our ability to successfully apply for and obtain FDA approval for IkT-001Pro in blood and stomach cancers or other indications. Additional factors include our ability to successfully conduct pre-clinical and clinical studies, and whether results of our animal studies translate to a clinical benefit in humans, as well as our need for additional financing and other such factors that are discussed in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contacts: Company Contact:Milton H. Werner, PhDPresident & CEO678-392-3419info@inhibikase.com Investor Relations:Alex LoboStern Investor Relations, Inc.alex.lobo@sternir.com