UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

________________________________

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported)

 

May 14, 2020

________________________________

 

CAPRICOR THERAPEUTICS, INC.

(Exact name of Registrant as Specified in its Charter)

 

Delaware   001-34058   88-0363465
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

8840 Wilshire Blvd., 2nd Floor, Beverly Hills, CA

(Address of principal executive offices)

 

90211

(Zip Code)

 

(310) 358-3200

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol(s)   Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share   CAPR   The Nasdaq Capital Market

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On May 14, 2020, Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), provided an update in the form of a slide presentation during its quarterly earnings call. The slide presentation is located on the “Investors” section of the Company’s website at www.capricor.com. A copy of the slide presentation is also attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.

 

The information contained in this Form 8-K (including Exhibit 99.1 attached hereto) is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.  

 

(d) Exhibits

 

  99.1 Capricor Therapeutics, Inc. slide presentation dated May 14, 2020.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

 

  CAPRICOR THERAPEUTICS, INC.  
       
Date:  May 14, 2020 By: /s/ Linda Marbán, Ph.D.  
    Linda Marbán, Ph.D.  
    Chief Executive Officer  

 

 

 

 

Exhibit 99.1

 

Capricor Q1 Earnings Call and Corporate Update 1 May 14, 2020 Earnings Call NASDAQ: CAPR

 
 

Capricor Therapeutics, Inc. Developing Transformative Therapies from Bench to Bedside Forward - Looking Statements 2 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 to obtain regulatory approvals or otherwise bring products to market ; plans regarding current and future collaborative activities and the ownership of commercial rights ; scope, duration, validity and enforceability of intellectual property rights ; future royalty streams, revenue projections ; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward - looking statements . There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward - looking statements . More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10 - K for the year ended December 31 , 2019 as filed with the Securities and Exchange Commission on March 27 , 2020 . All forward - looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward - looking statements . CAP - 1002 is an Investigational New Drug and is not approved for any indications . None of Capricor’s exosome - based candidates have been approved for clinical investigation .

 
 

Capricor Therapeutics, Inc. Developing Transformative Therapies from Bench to Bedside Immunomodulatory Effects of CAP - 1002 CDCs: Cardiosphere - derived cells Macrophages Effector T - cells Proinflammatory Cytokines IFN - γ , TNF α , IL - 1 β , IL - 6, IL - 8, CXCL10, CCL2, CCL3, CCL5 Systemic Inflammation Multiorgan dysfunction 1. Cardiac inflammation 2. Lung inflammation 3. Cardiomyocyte death 4. Cardiac dysfunction 5. Skeletal muscle injury 6. Tissue Fibrosis 1. Cardiomyogenesis 2. Cardiomyocyte survival 3. Anti - inflammatory 4. Immunomodulatory 5. Angiogenic 6. Anti - fibrotic CDCs: Mechanism of Action 1. Enhanced cell debris 2. Decreased TNF α , IL - 1 β , CCL5 production 3. Increased levels of IL - 10 by macrophages CDCs: Pro - inflammatory cellular targets 1. Myocardial ischemia (CADUCEUS, Phase I/II ALLSTAR, DYNAMIC Phase IIa ) 2. Myocarditis 3. Muscular dystrophy (HOPE - Duchenne, HOPE - 2) 4. Heart failure with preserved ejection fraction (REGRESS, Phase I) 5. Senescence 6. Non - ischemic dilated cardiomyopathy 7. Pulmonary arterial hypertension (ALPHA, Phase I) CDCs: Efficacy (Pre - clinical and Clinical) 3

 
 

Capricor Therapeutics, Inc. Developing Transformative Therapies from Bench to Bedside HOPE - 2 Top - Line 12 - month Data Summary 4 ▪ Upper Limb Function: ▪ Full PUL 2.0 – change observed of 2.4 points (p=0.05) ▪ Mid Level PUL 1.2 – change observed of 2.8 points (p=0.08) ▪ Full PUL 1.2 – change observed of 4.1 points (p=0.03) ▪ Cardiac Function: ▪ LV Ejection Fraction (%) – change observed of 1.56% (p=0.004) ▪ LVESV – improvements observed (p=0.01) ▪ LVEDV – improvements observed (p=0.07) ▪ CK - MB (% of total CK) – improvements observed (p=0.006) ▪ Respiratory Function: ▪ Trends towards improvements in IFR and PEF (% predicted) 4 4

 
 

Capricor Therapeutics, Inc. Developing Transformative Therapies from Bench to Bedside PUL 1.2 (mid) MONTH 12/ET C A P - 1 0 0 2 P L A C E B O -15 -10 -5 0 5 M e a n C h a n g e f r o m B a s e l i n e + / - S E M p=0.0974 (t test; two-tailed) 5 Primary Efficacy Endpoint - Performance of the Upper Limb ( Mid PUL 1.2) Comparisons treated vs. placebo using mixed model repeated measures ANOVA with covariates at baseline, 3 months, 6 months, 9 months and 12 months P - values are nominal values unadjusted for multiple testing Post - hoc analysis -6 -5 -4 -3 -2 -1 0 PUL 1.2 (mid) MONTH 12/ET M e a n C h a n g e f r o m B a s e l i n e + / - S E M CAP-1002 PLACEBO p=0.0005 Excludes non - responder (n=1) Complete data set 5

 
 

Capricor Therapeutics, Inc. Developing Transformative Therapies from Bench to Bedside -6 -5 -4 -3 -2 -1 0 PUL 2.0 (full) MONTH 12/ET M e a n C h a n g e f r o m B a s e l i n e + / - S E M CAP-1002 PLACEBO p=0.004 PUL 2.0 (full) MONTH 12/ET C A P - 1 0 0 2 P L A C E B O -8 -6 -4 -2 0 2 4 p=0.0201 (t test; two-tailed) M e a n C h a n g e f r o m B a s e l i n e + / - S E M Performance of the Upper Limb ( Full PUL 2.0) Excludes non - responder (n=1) Complete data set 6 Comparisons treated vs. placebo using mixed model repeated measures ANOVA with covariates at baseline, 3 months, 6 months, 9 months and 12 months P - values are nominal values unadjusted for multiple testing Post - hoc analysis