Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q4 2020 Earnings Conference Call March 11, 2021 4:30 PM ET Company Participants AJ Bergmann – Chief Financial Officer Linda Marbán – Chief Executive Officer Stephen Gould – Executive Consultant Conference Call Participants Michael Okunewitch – Maxim Group Emanuela Branchetti – H.C. Wainwright Alan Leong – BioWatch News Operator Greetings, and welcome to Capricor Therapeutics Fourth Quarter Full Year 2020 Earnings and Corporate Update Call. At this time, all particip ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2020 or ¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) Delaware 88-0363465 (State or other jurisdict ...

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q3 2020 Earnings Conference Call November 12, 2020 4:30 PM ET Company Participants A.J. Bergmann - Chief Financial Officer Linda Marbán - President, Chief Executive Officer and Director Steve Gould - Executive Consultant Conference Call Participants Emanuela Branchetti - H.C. Wainwright Jason McCarthy - Maxim Group Alan Leong - BioWatch News Operator Greetings, and welcome to the Capricor Therapeutics Inc Third Quarter 2020 Earnings Call. [Operator Instructions]. As ...

Corporate & Investor Presentation Capricor Therapeutics, Inc. Developing Transformative Therapies from Bench to Bedside NASDAQ: CAPR August 2020 Forward-Looking Statements Statements in this presentation regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulator ...

Clinical Trials and Drug Development - Capricor Therapeutics completed the HOPE-2 Phase II clinical trial for CAP-1002, showing statistically significant improvements in upper limb, cardiac, and respiratory function with p-values less than 0.05[203] - The 12-month data from the HOPE-2 trial indicated a mean change of 2.4 points in the PUL 2.0 for CAP-1002 treated patients compared to placebo, with a p-value of 0.05[203] - In the same trial, CAP-1002 demonstrated a reduction in CK-MB levels (p=0.006), indicating a decrease in cardiac muscle cell damage[204] - The primary efficacy endpoint of the HOPE-2 trial was the relative change in patients' abilities to perform manual tasks, measured through the Performance of the Upper Limb (PUL) test[200] - CAP-1002 was generally safe and well tolerated, with no significant safety signals identified during the HOPE-2 trial[208] - The Phase I/II HOPE-Duchenne clinical trial involved 25 patients, with a total dose of 75 million cells infused, showing significant improvement in motor function in 89% of lower-functioning patients treated with CAP-1002[216][217] - The FDA has granted CAP-1002 Orphan Drug Designation and Rare Pediatric Disease Designation, providing incentives such as tax credits and potential market exclusivity upon approval[219][220] - CAP-1002 is one of the few therapies in development for non-ambulant patients with DMD, with the FDA encouraging a Phase III study for its approval pathway[214][222] - Capricor has initiated a Phase II, randomized, placebo-controlled study for CAP-1002 in severe or critical COVID-19 patients, aiming to treat up to 60 patients[183] - The company is developing two vaccine candidates using its exosomes platform technology for potential COVID-19 prevention, with pre-clinical studies showing an antibody response[184] Financial Performance and Funding - Grant income for Q2 2020 was approximately $50,000, down from $144,000 in Q2 2019, primarily due to the timing of the DoD Grant Award expected to end in September 2020[237] - Miscellaneous income for Q2 2020 was zero, compared to approximately $300,000 in Q2 2019, attributed to delays in clinical trials sponsored by CSMC due to the COVID-19 pandemic[238] - The company has no commercial product sales to date and relies on grants and equity sales for funding its development programs[232] - The company reported a net loss of approximately $5.6 million for the six months ended June 30, 2020[249] - The company has raised approximately $20.2 million from the sale of 3,059,959 shares under the May 2020 ATM Program at an average price of approximately $6.59 per share[258] - The company has not generated any revenue from the commercial sale of its products to date and does not expect to generate revenue for several years, necessitating the need for substantial additional capital[254] - The company expects to spend approximately $4.0 million to $6.0 million in 2020 on the further development of CAP-1002 for DMD and COVID-19[244] - The company anticipates spending approximately $3.0 million to $6.0 million in 2020 on pre-clinical and other research expenses related to its exosomes program[246] Expenses and Financial Management - Research and development expenses primarily consist of clinical trial costs, personnel costs, and other related expenses, which are expected to increase as clinical development progresses[233] - General and Administrative (G&A) expenses for Q2 2020 were approximately $1.6 million, an increase of 100% compared to $0.8 million in Q2 2019, primarily due to a $0.5 million rise in stock-based compensation[240] - Research and Development (R&D) expenses for Q2 2020 were approximately $1.9 million, up 18.75% from $1.6 million in Q2 2019, driven by costs related to the COVID-19 exosome vaccine program[242] - Cash used in operating activities for the six months ended June 30, 2020, was approximately $3.2 million, a slight decrease from $3.4 million in the same period of 2019[250] - The company expects to record additional non-cash compensation expense in the future, which may be significant[292] Cash and Investments - Total cash, cash equivalents, and marketable securities as of June 30, 2020, were approximately $36.3 million, a significant increase from $9.9 million as of December 31, 2019, primarily due to net financing activities of approximately $29.7 million[249] - Cash flow from financing activities for the six months ended June 30, 2020, was approximately $29.7 million, compared to $2.0 million for the same period in 2019, reflecting a substantial increase due to the May 2020 ATM Program[253] - As of June 30, 2020, the fair value of the company's cash and cash equivalents was approximately $36.3 million[300] - The company issued a letter of credit amounting to $232,803 for its lease agreement, which was subsequently canceled and funds returned[294] Grants and Awards - The Company received a CIRM Grant Award of approximately $3.4 million for a clinical trial, requiring co-funding of approximately $2.3 million from the Company[267] - As of June 30, 2020, the liability balance for the CIRM Award was approximately $3.4 million, with all milestones completed in June 2019[269] - The Company was awarded approximately $2.4 million from the U.S. Department of Defense to develop a scalable process for manufacturing CAP-2003, with approximately $2.3 million incurred under the award as of June 30, 2020[270] - The Company accounts for the CIRM Award as a liability rather than income, as it may be required to repay some or all of the awarded amounts[283] Risk Management and Accounting - The company manages market risk by investing in highly rated credit issuers and does not hedge interest rate exposure[301] - The company's investment policy aims to limit credit exposure and improve the safety of invested funds[301] - The company calculates the fair value of stock options using the Black-Scholes option-pricing model, accounting for various assumptions[290] - Clinical trial expenses are accrued based on contracts with vendors and are adjusted as actual results differ from estimates[295] - The Company utilizes estimates for clinical trial costs based on contracts with various vendors, which may lead to significant differences between estimated and actual costs[285] - The Company has not recognized any adjustments for material changes in estimates in any presented period[287] - The company accounts for stock-based compensation expense in general and administrative or research and development expenses[292]

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q2 2020 Earnings Conference Call August 6, 2020 4:30 PM ET Company Participants Anthony Bergmann - CFO & Corporate Treasurer Linda Marbán - Co-Founder, President, CEO & Director Conference Call Participants Naureen Quibria - Maxim Group Alan Leong - BioWatch Operator Greetings, and welcome to the Capricor Therapeutics Second Quarter 2020 Earnings Call. [Operator Instructions]. As a reminder, this conference is being recorded Thursday, August 6, 2020. I would now lik ...

Capricor Therapeutics Inc. (NASDAQ:CAPR) Q1 2020 Earnings Conference Call May 14, 2020 4:30 PM ET Corporate Participants AJ Bergmann - CFO Linda Marban - CEO Conference Call Participants Emanuela Branchetti - H.C. Wainwright Alan Leong - BioWatch Operator Greetings and welcome to the Capricor Therapeutics Inc. First Quarter 2020 Earnings Conference Call. During the presentation, all participations will be in a listen-only mode. Afterward, we will conduct a question-and-answer session. [Operator Instructions ...

1 Capricor Q1 Earnings Call and Corporate Update May 14, 2020 Earnings Call NASDAQ: CAPR Forward-Looking Statements Statements in this presentation regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q þ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended March 31, 2020 or o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) Delaware 88-0363465 (State or other jurisdiction ...

Clinical Trials and Efficacy - The company is conducting the HOPE-2 Phase II clinical trial for CAP-1002, focusing on Duchenne muscular dystrophy (DMD), with 20 patients randomized to date [436]. - Interim results from the HOPE-2 trial showed meaningful improvements in skeletal assessments, with CAP-1002 demonstrating a mean change of 0.5 in shoulder and mid-level dimensions at 3 months compared to a -1.2 change in placebo (p-value 0.0549) [442]. - At 6 months, CAP-1002 showed a mean change of -0.3 in mid-level dimensions compared to -2.3 in placebo (p-value 0.0299), indicating significant efficacy [442]. - The primary efficacy endpoint of the HOPE-2 trial is the Performance of the Upper Limb (PUL) test, which assesses manual task performance critical to patients' daily living [437]. - The company plans to report final 12-month results from the HOPE-2 trial in the second quarter of 2020, which will inform the decision to conduct a Phase III trial [435]. - The FDA has indicated support for conducting a Phase III trial of CAP-1002 for DMD treatment, although it did not support an accelerated approval pathway based on interim data [449]. - CAP-1002 has been administered to approximately 150 human subjects across several clinical trials, demonstrating its potential in cardiac and skeletal muscle regeneration [425]. - The HOPE-Duchenne Phase I/II trial showed that 25 million cells of CAP-1002 were infused into each of the three main coronary arteries, totaling 75 million cells per patient, with a focus on safety and exploratory efficacy [451]. - CAP-1002 showed significant improvement in motor function, with 89% of lower-functioning patients maintaining or improving function at 12 months compared to 0% in the control group (p=0.007) [452]. Financial Performance and Funding - Grant income decreased from approximately $1.0 million in 2018 to $0.5 million in 2019, primarily due to the completion of the pre-clinical phase of the NIH grant [473]. - General and Administrative expenses decreased from approximately $4.9 million in 2018 to $3.6 million in 2019, a reduction of about $1.3 million [475]. - Research and Development expenses decreased significantly from approximately $12.1 million in 2018 to $5.1 million in 2019, a reduction of about $7.0 million [476]. - The company expects to spend approximately $2.0 million to $4.0 million on the clinical development of CAP-1002 during 2020 [478]. - The company anticipates spending approximately $2.0 million to $3.0 million on pre-clinical and research expenses related to its exosomes program in 2020 [479]. - Investment income decreased from $135,991 in 2018 to $94,791 in 2019 due to reduced capital [477]. - As of December 31, 2019, the company had cash, cash equivalents, and marketable securities totaling approximately $9.9 million, an increase from approximately $7.3 million as of December 31, 2018, primarily due to net financing activities of approximately $9.2 million [483][485]. - The company reported a net loss of approximately $7.6 million for the year ended December 31, 2019, a decrease of approximately $7.1 million compared to a net loss of $13.9 million in 2018 [486]. - Cash used in operating activities was approximately $6.8 million for the year ended December 31, 2019, compared to $13.9 million in 2018, reflecting improved operational efficiency [486]. - The company experienced cash flow from financing activities of approximately $9.2 million for the year ended December 31, 2019, an increase from $6.9 million in 2018, primarily due to net proceeds from the sale of common stock [488]. - The company initiated an at-the-market offering in August 2019, resulting in gross proceeds of approximately $1.1 million from the sale of 360,316 shares at an average price of approximately $3.07 per share [494]. - The company completed a public offering in December 2019, raising approximately $5.1 million, with net proceeds of approximately $4.4 million after fees [493]. - The company has not generated any revenue from the commercial sale of its products to date and does not expect to do so for several years, necessitating substantial additional capital to fund operations and research [490]. - The company received a CIRM grant award of approximately $3.4 million to fund its Phase I/II clinical trial for CAP-1002, with a co-funding requirement of approximately $2.3 million from its own capital [498]. - As of December 31, 2019, the company had approximately $4.3 million in total liabilities and $9.6 million in net working capital [485]. - The company anticipates continuing to incur substantial losses as it develops its product candidates and expands its technology portfolio [486]. - As of December 31, 2019, Capricor's liability balance for the CIRM Award was approximately $3.4 million [501]. - Capricor was approved for a NIH grant of up to approximately $4.2 million for studying CAP-2003, with $0.7 million incurred as of June 30, 2019 [502]. - Capricor received a DoD grant award of approximately $2.4 million for developing a scalable process to manufacture CAP-2003, with $2.2 million incurred as of December 31, 2019 [503]. - Capricor completed all milestones associated with the CIRM Award and expended all funds received by June 2019 [501]. - The company accounts for the CIRM Award as a liability rather than income due to potential repayment obligations [511]. Expenses and Financial Management - R&D expenses primarily consist of salaries, clinical trial costs, and other related expenses, which are expensed as incurred [512]. - Stock-based compensation expense is recorded over the vesting period, with significant future non-cash compensation expected [520]. - The company has not recognized any adjustments for material changes in estimates in any period presented [515]. - Capricor has entered into a letter of credit for lease security, amounting to $232,803, which was subsequently cancelled [522]. - The adoption of ASU 2016-02 on leases did not have a material impact on the company's financial statements [525]. - As of December 31, 2019, the fair value of the company's cash, cash equivalents, and marketable securities was approximately $9.9 million [530]. - The investment policy aims to limit credit exposure by investing in highly rated credit issuers [531]. - The company does not hedge interest rate exposure and believes a hypothetical 100 basis point change in interest rates would not significantly impact the fair value of its investment portfolio [531]. Regulatory Designations - CAP-1002 received Orphan Drug Designation from the FDA in April 2015, providing incentives such as tax credits and potential seven-year market exclusivity upon approval [454]. - In July 2017, CAP-1002 was granted Rare Pediatric Disease Designation, allowing eligibility for a Priority Review Voucher upon approval of a qualifying application [456]. - CAP-1002 received Regenerative Medicine Advanced Therapy (RMAT) designation in February 2018, expediting development and review processes [457].