Latest news with #IGF-1R
Business Wire
30-07-2025
- Business
- Business Wire
Viridian Therapeutics Announces Collaboration and License Agreement with Kissei Pharmaceutical to Develop and Commercialize Veligrotug and VRDN-003 in Japan with an Upfront Payment of $70 Million and up to $315 Million in Milestone Payments
WALTHAM, Mass.--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases, today announced that it has entered into an exclusive collaboration and license agreement with Kissei Pharmaceutical Co., Ltd. ('Kissei') to develop and commercialize veligrotug and VRDN-003 in Japan. Both molecules are anti-insulin-like growth factor-1 receptor (IGF-1R) antibodies for the potential treatment of patients with thyroid eye disease (TED), and VRDN-003 is a potential best-in-class, subcutaneous, half-life extended anti-IGF-1R antibody with the same binding domain as veligrotug. TED is an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eye, often causing swelling, discomfort, and double vision, among other signs and symptoms. 'After running a very competitive partnering process, we are thrilled to partner with Kissei to bring these potential best-in-class medicines to TED patients in Japan,' said Steve Mahoney, Viridian's President and CEO. 'Kissei has an established strong track record of successfully developing and commercializing in-licensed, rare disease medicines. Kissei shares our enthusiasm and commitment to these programs, and we believe Kissei is an ideal partner for us in Japan. Both companies look forward to moving quickly to advance these novel treatment options for patients.' 'As we seek to further expand our pipeline in rare and intractable diseases, we are very excited by the potential of veligrotug and VRDN-003 to address the significant unmet needs of TED patients in Japan, based on veligrotug's strong and consistent phase 3 clinical data in THRIVE and THRIVE-2,' said Mutsuo Kanzawa, Chairman and CEO of Kissei. 'This collaboration reinforces our mission to contribute to the health of people around the world through innovative pharmaceutical products, and we are committed to bringing important treatment options to Japanese patients as rapidly as possible.' Under the terms of the agreement, Viridian will grant Kissei an exclusive license to develop and commercialize veligrotug and VRDN-003 in Japan. Viridian will receive an upfront cash payment of $70 million, with the potential to receive an additional $315 million in development, regulatory, and commercial milestone payments, as well as tiered royalties on net sales in Japan with percentages ranging from the 20s to mid-30s. Kissei will be responsible for all development, regulatory, and commercialization activities, and associated costs, in Japan. Renexes LLC served as an advisor to Viridian in connection with the transaction. About Viridian Therapeutics Viridian is a biopharmaceutical company focused on discovering, developing and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian's expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas. Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit Follow Viridian on LinkedIn and X. About Kissei Pharmaceutical Co., Ltd. Kissei is a Japanese pharmaceutical company based on the management philosophy 'contributing to society through high-quality, innovative pharmaceutical products' and 'serving society through our employees.' As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide. Kissei is engaged in bringing new drugs into the world through drug discovery and licensing activities in its focus fields of rare/intractable diseases, urology, and nephrology/dialysis. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, 'anticipate,' 'believe,' 'become,' 'continue,' 'could,' 'design,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'on track,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' or 'would' or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: Viridian's partnership with Kissei; Viridian's ability to achieve development, regulatory, and commercial milestone payments and receive royalties on the commercial sale of our product candidates pursuant to the agreement with Kissei; clinical development and anticipated commercialization of Viridian's product candidates, including veligrotug (formerly VRDN-001) and VRDN-003; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug and VRDN-003; Viridian's product candidates potentially being best-in-class; whether veligrotug and VRDN-003 will serve an unmet need; and Viridian's expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including under the agreement with Kissei. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian's product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; expectations and changes regarding the timing for regulatory filings; regulatory interactions; uncertainty and potential delays related to clinical drug development; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; competition from other therapies or products; estimates of market size; our future operating results and financial performance; Viridian's intellectual property position; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the 'Risk Factors' section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date hereof.
Business Wire
18-06-2025
- Business
- Business Wire
Sling Therapeutics Appoints Ken Lock as Chief Commercial Officer
BUSINESS WIRE)-- Sling Therapeutics, Inc., a biopharmaceutical company focused on late-stage development of an oral small molecule for the treatment of thyroid eye disease (TED), today announced the appointment of Ken Lock as Chief Commercial Officer. Linsitinib has the potential to be a transformative oral small molecule therapy for TED patients, offering a compelling and convenient alternative to currently available treatments. 'We are delighted to welcome Ken as Sling's Chief Commercial Officer. He brings deep expertise across marketing, sales and market access in competitive markets along with a proven track record building and leading high-performing commercial organizations, which will be instrumental as we advance linsitinib to a confirmatory Phase 3 study in patients with thyroid eye disease,' said Ryan Zeidan, Ph.D., President and Chief Executive Officer of Sling Therapeutics. 'Ken shares our deep commitment to improving the lives of patients and their families, and we look forward to working alongside him to help deliver linsitinib to the people who need it most.' 'Joining Sling Therapeutics at this pivotal stage in the development of linsitinib is an exciting opportunity," shared Lock, who brings extensive U.S. and global commercial leadership experience to his role. 'Linsitinib has the potential to be a transformative oral small molecule therapy for TED patients, offering a compelling and convenient alternative to currently available treatments. I am excited to join this highly accomplished team as we work to address the significant unmet needs of TED patients.' Most recently, Lock served as Chief Commercial Officer at ACELYRIN, where he led the commercial, medical affairs, and alliance management functions in the TED market. Lock also served as Chief Commercial Officer at Arcutis Biotherapeutics, where he built and led a team of over 130 people and was responsible for the launch and brand development of ZORYVE®. Prior to that, he held sales and marketing roles of increasing responsibility at Gilead Sciences, Amgen, and Wyeth (now Pfizer). Lock holds an M.B.A. from the Cornell Johnson Graduate School of Management and a dual B.S. and B.A. in Biochemistry/Cell Biology and Psychology from the University of California, San Diego. About Thyroid Eye Disease (TED) Thyroid Eye Disease (TED) is a serious, progressive, and vision-threatening rare autoimmune disease that affects approximately 70,000 people in the U.S. and has a similar prevalence in the EU. TED often occurs in people living with Graves' disease and hyperthyroidism and is caused by dysfunction in the IGF-1R signaling pathway, which results in fibrous tissue growth behind the eyes. This leads to several negative symptoms that may have long-term, irreversible damage as the tissue growth pushes the eyes forward or causes the eyes and eyelids to become red and swollen. As the disease progresses, it can lead to pain, eye bulging (proptosis), and double vision (diplopia), thus dramatically impacting a patient's quality of life. TED predominantly affects women, and most frequently affects people with hyperthyroidism due to Graves' disease. The current standard of care typically involves either invasive orbital surgery or a lengthy series of infusions with potential adverse events like loss of hearing, hyperglycemia, or menstrual cycle changes. About Sling Therapeutics Sling Therapeutics is an innovative biopharmaceutical company whose lead product candidate, linsitinib, has the potential to be the first oral IGF-1R inhibitor to treat thyroid eye disease (TED). Linsitinib is in late-stage clinical development for TED, which is an autoimmune disease with a significant unmet need, as current treatment options are limited to invasive orbital surgery or a lengthy series of infusions. Sling aims to bring a convenient oral therapy to improve patients' quality of life and reduce physician and healthcare system burden. For more information, visit
Business Wire
07-05-2025
- Business
- Business Wire
Viridian Therapeutics Receives FDA Breakthrough Therapy Designation for Veligrotug for the Treatment of Thyroid Eye Disease (TED)
WALTHAM, Mass.--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to veligrotug ('veli'), the company's lead anti-insulin-like growth factor-1 receptor (IGF-1R) drug candidate for the treatment of TED. Breakthrough Therapy Designation is reserved for drug candidates intended to treat serious or life-threatening conditions that address an unmet need where clinical evidence has indicated they may demonstrate substantial improvement on a clinically significant endpoint over existing therapies. 'The FDA's decision to grant veli Breakthrough Therapy Designation underscores that veli may offer substantial improvement over existing therapies, and we believe it reinforces veli's potential to be a differentiated, treatment-of-choice for patients living with TED,' said Steve Mahoney, Viridian's President and CEO. 'Veli is the only therapy that has demonstrated statistically significant and clinically meaningful improvement and resolution of diplopia in both active and chronic TED. Veli also showed a rapid onset of treatment effect, including an improvement in proptosis response in as few as three weeks after just one infusion. We believe veli will be an important potential new treatment option for patients living with TED, including whose disease is unaddressed by existing therapies. We continue to execute on our planned BLA submission in the second half of 2025 and are excited that this designation supports eligibility for Priority Review as we prepare for our planned U.S. commercial launch in 2026.' THRIVE and THRIVE-2, phase 3 clinical trials in active and chronic TED respectively, comprise the largest pivotal program to date in TED. In both clinical trials, veligrotug met all of its primary and secondary endpoints and was generally well-tolerated. THRIVE-2 was the first global phase 3 clinical trial to demonstrate a statistically significant diplopia response and resolution in chronic TED patients. About Veligrotug Veligrotug is an intravenously (IV) delivered, anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease, with the potential to be the IV treatment-of-choice for active and chronic TED patients. IGF-1R is a clinically and commercially validated target for thyroid eye disease (TED) with U.S. revenues of approximately $2 billion in 2024. Veligrotug has the potential to improve patient experience with a differentiated dosing regimen that features a shorter infusion time and fewer infusions compared to the currently approved and marketed IGF-1R inhibitor. In its pivotal phase 3 clinical trials, THRIVE and THRIVE-2, veligrotug met all of its primary and secondary endpoints. Veligrotug demonstrated a rapid onset of treatment effect and statistically significant and clinically meaningful reduction and resolution of diplopia in both clinical trials. THRIVE-2 was the first demonstration in a global phase 3 clinical trial of a statistically significant diplopia response and resolution in chronic TED patients. Veligrotug was generally well tolerated. Viridian believes that the differentiated Veligrotug has the potential to establish a strong position in the TED commercial market, if approved, and may help facilitate the introduction of VRDN-003, its potential best-in-class subcutaneous IGF-1R antibody for TED. About Viridian Therapeutics Viridian is a biopharmaceutical company focused on discovering, developing and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian's expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas. Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit Follow Viridian on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, 'anticipate,' 'believe,' 'become,' 'continue,' 'could,' 'design,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'on track,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' or 'would' or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: clinical development and anticipated commercialization of Viridian's product candidates, including veligrotug (formerly VRDN-001) and VRDN-003; the impact of Breakthrough Therapy Designation, including eligibility for Priority Review, or any other FDA designations; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated BLA submission for veligrotug in the second half of 2025; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience, and number of indications of veligrotug and VRDN-003; veligrotug's potential to be a differentiated, IV treatment-of-choice for active and chronic TED or an important potential new treatment option; potential market sizes and market opportunities, including for Viridian's product candidates; Viridian's product candidates potentially being best-in-class; whether veligrotug will serve an unmet need; whether veligrotug may offer substantial improvement over existing therapies; and Viridian's expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including the potential U.S. launch of veligrotug in 2026. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of Viridian's product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; expectations and changes regarding the timing for regulatory filings; regulatory interactions; uncertainty and potential delays related to clinical drug development; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; competition from other therapies or products; estimates of market size; our future operating results and financial performance; Viridian's intellectual property position; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the 'Risk Factors' section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date hereof. Source: Viridian Therapeutics, Inc.
Associated Press
04-03-2025
- Business
- Associated Press
Lirum Therapeutics Presents Positive Data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress; Highlighting LX-101's Promise in IGF-1R Prominent Cancers
New York, NY, March 04, 2025 (GLOBE NEWSWIRE) -- Lirum Therapeutics, Inc. ('Lirum'), an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases, announced today the presentation of additional positive data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress (TAT) in Paris, France. LX-101, a novel clinical-stage payload-bearing targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), was selected for two presentations at this year's TAT conference. The first presentation, co-authored with investigators from the MD Anderson Cancer Center, showcases LX-101's strong in vivo activity in Ewing sarcoma as well as its potency in in vitro models of both Ewing sarcoma and desmoplastic small round cell tumor (DSRCT). These cancers have strong ties to IGF-1R, including DNA-level gene fusions that affect this signaling pathway. The second presentation highlights LX-101's broad potency against a host of IGF-1R-expressing cell lines from a number of additional adult cancers including lung, esophageal and stomach cancers, which represent large market opportunities. These presentations underscore LX-101's potent activity and promise in both pediatric and adult cancers with well-established ties to the IGF-1R pathway. The presentations are entitled: LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Anti-Tumor Activity in Ewing Sarcoma Animal Models and Desmoplastic Small Round Cell Tumors. LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Preclinical Anti-Tumor Activity Against Multiple Cancer Types with Elevated IGF-1R Expression. Both presentations are available on the Lirum website ( under the Investors and Media tab. Given these promising results, new clinical trials with LX-101 are planned in pediatric indications that carry strong ties to the IGF-1/IGF-1R pathway, including Ewing Sarcoma, DSRCT, rhabdomyosarcoma, and GIST. In addition, Lirum is planning trials in adult patients with cancer types that are naturally enriched for IGF-1R, including certain head and neck indications and others. In parallel, Lirum is also focused on developing LX-101 in thyroid eye disease (TED), where IGF-1R has been clinically and commercially validated. About Lirum Therapeutics, Inc. Lirum is an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases through the acquisition, development and commercialization of novel drug candidates with compelling mechanisms of action, regulatory pathways and commercial opportunities. Lirum's lead candidate, LX-101, is a novel clinical-stage targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R) with a differentiated mechanism of action. Lirum is developing LX-101 in oncology and autoimmune indications, including thyroid eye disease (TED). For more information on Lirum, please visit Forward Looking Statements This press release contains certain 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 'future,' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Lirum's current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, the following: (1) the ability of Lirum to successfully develop its product candidates, including obtaining positive results from planned clinical trials, 2) expectations for the clinical development, manufacturing, regulatory approval and commercialization of our product candidates or other products we may acquire or in-license(3) expectations for incurring capital expenditures and generating revenue, 4) estimates of the sufficiency of our existing cash and cash equivalents and investments to finance operations, 5) changes in applicable laws or regulations; (6) the possibility that Lirum may be adversely affected by other economic, business, and/or competitive factors; (7) the impact of health epidemics, including the COVID-19 pandemic, on Lirum's business and the actions Lirum may take in response thereto; and (8) other risks and uncertainties indicated from time to time. There may be additional risks that Lirum considers immaterial or which are unknown. Any forward-looking statement made by us in this press release is based only on information currently available to Lirum and speaks only as of the date on which it is made. Lirum undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law. Also, the information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company contact: Matt Hoberman Lirum Therapeutics, Inc. 1270 Ave of the Americas, 7th Floor New York, NY 10020
Yahoo
04-03-2025
- Business
- Yahoo
Lirum Therapeutics Presents Positive Data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress; Highlighting LX-101's Promise in IGF-1R Prominent Cancers
New York, NY, March 04, 2025 (GLOBE NEWSWIRE) -- Lirum Therapeutics, Inc. ('Lirum'), an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases, announced today the presentation of additional positive data on LX-101 at the 2025 ESMO Targeted Anticancer Therapies Congress (TAT) in Paris, France. LX-101, a novel clinical-stage payload-bearing targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), was selected for two presentations at this year's TAT conference. The first presentation, co-authored with investigators from the MD Anderson Cancer Center, showcases LX-101's strong in vivo activity in Ewing sarcoma as well as its potency in in vitro models of both Ewing sarcoma and desmoplastic small round cell tumor (DSRCT). These cancers have strong ties to IGF-1R, including DNA-level gene fusions that affect this signaling pathway. The second presentation highlights LX-101's broad potency against a host of IGF-1R-expressing cell lines from a number of additional adult cancers including lung, esophageal and stomach cancers, which represent large market opportunities. These presentations underscore LX-101's potent activity and promise in both pediatric and adult cancers with well-established ties to the IGF-1R pathway. The presentations are entitled: LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Anti-Tumor Activity in Ewing Sarcoma Animal Models and Desmoplastic Small Round Cell Tumors. LX-101, a Novel, Clinical Stage, Payload-Bearing Targeted Therapy Directed to the Insulin-Like Growth Factor Receptor (IGF-1R), Demonstrates Potent Preclinical Anti-Tumor Activity Against Multiple Cancer Types with Elevated IGF-1R Expression. Both presentations are available on the Lirum website ( under the Investors and Media tab. Given these promising results, new clinical trials with LX-101 are planned in pediatric indications that carry strong ties to the IGF-1/IGF-1R pathway, including Ewing Sarcoma, DSRCT, rhabdomyosarcoma, and GIST. In addition, Lirum is planning trials in adult patients with cancer types that are naturally enriched for IGF-1R, including certain head and neck indications and others. In parallel, Lirum is also focused on developing LX-101 in thyroid eye disease (TED), where IGF-1R has been clinically and commercially validated. About Lirum Therapeutics, is an innovative clinical-stage biopharmaceutical company focused on the treatment of debilitating diseases through the acquisition, development and commercialization of novel drug candidates with compelling mechanisms of action, regulatory pathways and commercial opportunities. Lirum's lead candidate, LX-101, is a novel clinical-stage targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R) with a differentiated mechanism of action. Lirum is developing LX-101 in oncology and autoimmune indications, including thyroid eye disease (TED). For more information on Lirum, please visit Forward Looking StatementsThis press release contains certain 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: 'target,' 'believe,' 'expect,' 'will,' 'may,' 'anticipate,' 'estimate,' 'would,' 'positioned,' 'future,' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Lirum's current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, the following: (1) the ability of Lirum to successfully develop its product candidates, including obtaining positive results from planned clinical trials, 2) expectations for the clinical development, manufacturing, regulatory approval and commercialization of our product candidates or other products we may acquire or in-license(3) expectations for incurring capital expenditures and generating revenue, 4) estimates of the sufficiency of our existing cash and cash equivalents and investments to finance operations, 5) changes in applicable laws or regulations; (6) the possibility that Lirum may be adversely affected by other economic, business, and/or competitive factors; (7) the impact of health epidemics, including the COVID-19 pandemic, on Lirum's business and the actions Lirum may take in response thereto; and (8) other risks and uncertainties indicated from time to time. There may be additional risks that Lirum considers immaterial or which are unknown. Any forward-looking statement made by us in this press release is based only on information currently available to Lirum and speaks only as of the date on which it is made. Lirum undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law. Also, the information found on our website is not incorporated by reference into this press release and is included for reference purposes only. Company contact: Matt HobermanInvestor RelationsIR@ Phone: (646) 389-6015 Lirum Therapeutics, Inc.1270 Ave of the Americas, 7th FloorNew York, NY 10020 Sign in to access your portfolio
