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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): October 5, 2023

 

Longeveron Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40060   47-2174146
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

1951 NW 7th Avenue, Suite 520, Miami, Florida 33136

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (305) 909-0840

 

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))

 

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

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Class A Common Stock, $0.001 par value per share   LGVN   The Nasdaq Capital Market
Transferable Subscription Rights   LGVNR   The Nasdaq Capital Market

 

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

 

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.

 

 

 

 

 

 

Item 8.01. Other Events.

 

On October 5, 2023, Longeveron Inc. (the “Company”) issued a press release announcing positive top-line results for Lomecel-BTM in its CLEAR-MIND Phase 2a Clinical Trial in the Treatment of Mild Alzheimer’s Disease. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.

 

During a conference call and webcast scheduled to be held at 8:00 AM ET on October 5, 2023, the Company’s management will discuss the results from its CLEAR-MIND Phase 2a Clinical Trial in the Treatment of Mild Alzheimer’s Disease. The slide presentation for the conference call and webcast is furnished as Exhibit 99.2 hereto and is incorporated by reference herein.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

The exhibits listed in the following Exhibit Index are furnished as part of this Current Report on Form 8-K.

 

Exhibit No.   Description
99.1   Press Release issued by the Company on October 5, 2023
99.2   Company Slide Presentation
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

SIGNATURE

 

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

 

  LONGEVERON INC.
   
Date: October 5, 2023 /s/ Wa’el Hashad 
  Name:  Wa’el Hashad
  Title: Chief Executive Officer

 

 

2

 

Exhibit 99.1

 

 

Longeveron Announces Positive Top-Line Results for Lomecel-BTM in its CLEAR MIND Phase 2a Clinical Trial in the Treatment of Mild Alzheimer’s Disease

 

Company to Hold Conference Call & Webcast Today, October 5 at 8:00am ET

 

Primary Endpoint of Safety Met Across all Study Groups

 

Statistical Significance Met for Secondary Endpoint Composite Alzheimer’s Disease Score (CADS) for Lomecel-BTM Low-Dose and for the Pooled Lomecel-BTM Treatment Group Relative to Placebo

 

Other Doses Demonstrated Numerical Slowing/Prevention of Disease Worsening Relative to Placebo

 

Additional Biomarker Data Expected to be Announced in the Coming Weeks

 

MIAMI, October 5, 2023 (GLOBE NEWSWIRE) – Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, today announced positive top-line results from its Phase 2a trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer’s disease. The Company is hosting a conference call and webcast today at 8:00 AM ET to discuss the results.

 

“We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-BTM in the treatment of Alzheimer’s disease and provide a robust foundation for additional clinical trials in this and other indications,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We look forward to announcing additional biomarker data from this trial, anticipated to be later this month, which may further characterize the clinical effects of Lomecel-BTM in this study population. With our Phase 2 ELPIS II trial in HLHS moving toward anticipated completion in 2024, and our Phase 2 program in Aging-related Frailty progressing in Japan as well, we look forward to meaningful milestones in the near term and to fully realizing the therapeutic potential of Lomecel-BTM.”

 

“These study results with Lomecel-BTM are encouraging,” added Dr. Jeffrey Cummings, MD, Vice Chair of Research, UNLV Department of Brain Health. “The study met its primary safety endpoint and is supported by lack of deterioration in cognitive or atrophy signals. The efficacy observations are encouraging, and these results should be used as a foundation for further studies.”

 

“We are encouraged by these results, which appear to be further supported by their consistency with the findings from Longeveron’s earlier Phase I study on Alzheimer’s disease,” concluded Dr. Nataliya Agafonova, Chief Medical Officer of Longeveron.”

 

An estimated 6.7 million Americans are living with Alzheimer’s disease. Of the total U.S. population, about 1 in 9 people aged 65 and older has Alzheimer’s disease. The percentage of people with Alzheimer’s disease increases with age. Despite progress for new anti-amyloid treatment, there remains a high unmet medical need.

 

 

 

 

 

Conference Call and Webcast Details
Investors Dial-In 1-877-407-0789
International Investors Dial-In 1-201-689-8562
Conference ID# 13741797
Call me™ Feature Click Here
Webcast Click Here

 

Results:

 

The primary endpoint of safety was met based on statistical and medical assessment. There was one Serious Adverse Event (SAE) reported on each Lomecel-B™ treatment group and none on placebo. Each SAE was reviewed and assessed by the Data and Safety Monitoring Board (DSMB) with no safety issues raised.

 

The study safety data were consistent with an established safety profile with no incidence of hypersensitivity, no cases of Alzheimer Related Imagine Abnormalities (ARIA), no clinically asymptomatic microhemorrhages as revealed by Magnetic Resonance Imaging (MRI), and no notable changes in laboratory evaluations and electrocardiogram (EKG).

 

The secondary endpoint of change from baseline to week 39 in CADS, demonstrated positive results, at the prespecified statistical level of p<0.1, 2-tailed:

 

Statistically significant improvement at Week 39 in CADS was observed for the Lomecel-BTM 25 x 106 cells (25M) x 1 dose (p=0.091) versus placebo and for the pooled Lomecel-BTM Groups (25M x 1 dose, 25M x 4 doses, 100 x 106 cells (100M) x 4 doses) (p=0.099).

 

In terms of the specific components of the CADS score, evaluated at p<0.05, 2-tailed:

 

Lomecel-BTM (25M x 1 dose) demonstrated statistically significant slowing of disease progression in left hippocampal volume (p=0.015) relative to placebo

 

ADCS-ADL and left hippocampal volume at Week 39 were statistically significant for the pooled Lomecel-BTM treatment groups (25M x 1 dose, 25M x 4 doses, 100M x 4 doses) relative to placebo (p=0.047) and (p=0.038), respectively

 

Other doses demonstrated numerical slowing and prevention of disease worsening relative to placebo in CADS, ADAS-cog13, CDR-SB, ADCS-ADL and left hippocampal volume at Week 39

 

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About The CLEAR MIND Study

 

The trial was designed to study Lomecel-BEffects on mild Alzheimer’s disease: A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial (NCT05233774), named the CLEAR MIND trial. The trial included a total of 50 patients who were 60-85 years old and had a diagnosis of mild Alzheimer’s disease in accordance with National Institutes of Health – Alzheimer’s Association (NIA-AA) criteria, Mini-Mental State Examination (MMSE) score of 18-24, and a brain MRI and positron emission tomography (PET) scan consistent with Alzheimer’s disease. The trial was designed to test three different dosing regimens of Lomecel-B™ vs. placebo, and patients were randomized in a 1:1:1:1 ratio. The following doses were studied: Lomecel-B™ at a dose of 25 x 106 cells (25M) on Day 0, followed by placebo infusions at Week 4, Week 8 and Week 12; Lomecel-B™ at a dose of 25M administered on Day 0, Week 4, Week 8, and Week 12 for a total of 4 doses; and at a dose of 100 x 106 cells (100M) administered on Day 0, Week 4, Week 8, and Week 12, for a total of 4 doses.

 

The trial randomized 50 patients (49 were treated) and was conducted at 10 centers in the US. The primary endpoint of the trial is safety as measured by the occurrence of serious adverse events (SAEs) within the first 30 days after each administration of Lomecel-B™.

 

In consideration of the study sample size (N=49 patients), the study employed a novel global statistical test approach known as a Composite Alzheimer’s Disease Score (CADS, which is accepted and increasingly used by the scientific community for AD clinical trials). The CADS served as the secondary outcome measure of the trial and combined information across cognitive, functional capacity, and brain MRI domains.

 

The Secondary Endpoint definition is the change from baseline to Week 39 in the CADS. This score comprised of ADAS-cog-13, ADCS-ADL, CDR-SB, and left hippocampal volume (normalized for intercranial volume).

 

For efficacy analysis, testing of the secondary endpoint proceeded using a pre-specified, two-sided alpha of 0.1. If statistical significance was achieved at this level for any dose comparison, the study was considered positive and supportive of further study of Lomecel-B™ in a larger, higher-powered study. The individual components of the CADS were evaluated at two-sided alpha of 0.05.

 

Additional exploratory endpoints including brain volumetry by MRI, biomarkers relevant to inflammation and endothelial/vascular systems, and measures of cognitive function will be reported in the future.

 

Assessment Scales

 

ADAS-cog-13 — Alzheimer’s Disease Assessment Scale-Cognitive 13

CDR-SB — Clinical Dementia Rating Scale Sum of Boxes

ADCS-ADL — Alzheimer’s Disease Cooperative Study Activity of Daily Living

 

3

 

 

 

About Lomecel-B

 

Lomecel-B™ is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as medicinal signaling cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that Lomecel-B™ may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.

 

About Longeveron Inc.

 

Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™ an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently advancing Lomecel-B™ through clinical trials in three indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. Additional information about the Company is available at www.longeveron.com.

 

Forward-Looking Statements

 

Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “believe,” “expects,” “may,” “looks to,” “will,” “should,” “plan,” “intend,” “on condition,” “target,” “see,” “potential,” “estimates,” “preliminary,” or “anticipates” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, statements about the ability of Longeveron’s clinical trials to demonstrate safety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product candidates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s plans relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’s plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain such personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s need to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on its investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash and cash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

 

Investor Contact

 

Mike Moyer

LifeSci Advisors

Tel: 617-308-4306

Email: [email protected]

 

 

4

 

 

Exhibit 99.2

 

Cell - Based Therapies 05 October 2023 CLEAR MIND Phase 2a Proof Of Concept Topline Results

 

 

• Certain statements in this presentation that are not historical facts are forward - looking statements made pursuant to the safe h arbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estim ate s of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to diffe r m aterially from those anticipated by the statements made herein. Forward - looking statements are generally identifiable by the use of forward - looking t erminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "e stimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events , c ircumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward - looking sta tements in this presentation include, but are not limited to, statements about the ability of Longeveron’s clinical trials to demonstrate saf ety and efficacy of the Company’s product candidates, and other positive results; the timing and focus of the Company’s ongoing and future preclinica l s tudies and clinical trials and the reporting of data from those studies and trials; the size of the market opportunity for the Company’s product can didates, including its estimates of the number of patients who suffer from the diseases being targeted; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of the Company’s product candidates; the Com pany’s ability to obtain and maintain regulatory approval of its product candidates in the U.S., Japan and other jurisdictions; the Company’s p lan s relating to the further development of its product candidates, including additional disease states or indications it may pursue; the Company’ s p lans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and its ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and the Company’s ability to attract and retain su ch personnel; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’ s n eed to raise additional capital, and the difficulties it may face in obtaining access to capital, and the dilutive impact it may have on i ts investors; the Company’s financial performance and ability to continue as a going concern, and the period over which it estimates its existing cash an d c ash equivalents will be sufficient to fund its future operating expenses and capital expenditure requirements. Further information relating to fac tor s that may impact the Company's results and forward - looking statements are disclosed in the Company's filings with the Securities and Exchange Com mission, including Longeveron’s Annual Report on Form 10 - K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 14, 2023 and its Quarterly Report on Form 10 - Q for the second quarter of 2023 filed with the SEC on August 11, 2023. The f orward - looking statements contained in this presentation are made as of the date of this presentation, and the Company disclaims any in tention or obligation, other than imposed by law, to update or revise any forward - looking statements, whether as a result of new informatio n, future events, or otherwise. Forward - Looking Statements 2

 

 

Study Schema 3 Screening Baseline Randomization 1:1:1:1 Infusion 1 - 4: Placebo Group 1 (n=12) Infusion 1: 25M Lomecel - B Infusions 2 - 4: Placebo Group 2 (n=12) Infusions 1 - 4: 25M Lomecel - B Group 3 (n=12) Infusions 1 - 4: 100M Lomecel - B Group 4 (n=12) Infusions: Day 0, Week 4, Week 8 & Week 12 Follow - up Day 0 Wk 4 Wk 8 Wk 12 Wk 16 Visits Wk 26 Wk 39 / Study Completion • Age 60 - 85 • Dx of Mild AD • MMSE 18 - 24 • Brain MRI • PET Scan • CADS • Biomarkers • CADS • Biomarkers • Neuro Assessments • QOL & ADR • Brain MRI • Endothelial Function Testing Wk - 6 Wk - 4 45 weeks • Secondary Endpoint - CADS - A c omposite AD score calculated using z - scores for the ADCS - ADL, CDR - SB, ADAS - Cog - 13, and left hippocampal volume (normalized for intracranial volume) via MRI. • Primary Endpoint - Safety

 

 

Summary of Baseline Demographics 4 All Patients (N=49) G4: 100M x 4 (N=11) G3: 25M x 4 (N=13) G2: 25M x 1 (N=13) G1: Placebo (N=12) Statistic ITT Population 74.1 (6.65) 74.5 (6.07) 70.5 (7.14) 74.9 (7.51) 76.7 (4.40) Mean (SD) Age (Years) 22 (44.9) 27 (55.1) 5 (45.5) 6 (54.5) 7 (53.8) 6 (46.2) 5 (38.5) 8 (61.5) 5 (41.7) 7 (58.3) n (%) Gender Male Female 47 (95.9) 2 (4.1) 9 (81.8) 2 (18.2) 13 (100) 0 13 (100) 0 12 (100) 0 n (%) Race White Black/African American 37 (75.5) 12 (24.5) 7 (63.6) 4 (36.4) 10 (76.9) 3 (23.1) 11 (84.6) 2 (15.4) 9 (75.0) 3 (25.0) n (%) Ethnicity Hispanic or Latino Not Hispanic or Latino 28.9 (5.492) 27.8 (4.058) 30.4 (5.387) 27.1 (5.346) 30.4 (6.629) Mean (SD) BMI (kg/m 2 ) *G3: 25M x 4 slightly younger.

 

 

Primary endpoint met based on statistical and medical evaluation Primary Endpoint – SAEs 4 Weeks After Any Infusion 5 Pooled 3 and 4 (N=24) Pooled 2, 3 and 4 (N=37) G4: 100M x 4 (N=11) G3: 25M x 4 (N=13) G2: 25M x 1 (N=13) G1: Placebo (N=12) Statistic 1 Adverse Events ITT population 2 (8.3) (1.0, 27.0) 3 (8.1) (1.7, 21.9) 1 (9.1) (0.2, 41.3) 1 (7.7) (0.2, 36.0) 1 (7.7) (0.2, 36.0) 0 (0.0, 26.5) n (%) 95% CI Number of patients with at least one SAE after any infusion CTCAE Grade Outcome Related Action Taken with Study Drug Onset After Infusion # Infusion Date Arm MedDRA PT 2 Grade 3 Resolved Not Related None Infusion 4 G4 Acute respiratory failure Grade 3 Resolved Not Related None Infusion 3 G3 Anaemia Grade 4 Resolved Not Related None Infusion 4 G2 Lumbar radiculopathy

 

 

Most Frequent TEAEs 6 All Patients N=(49) G4: 100M x 4 (N=11) G3: 25M x 4 (N=13) G2: 25M x 1 (N=13) G1: Placebo (N=12) Adverse Events ITT Population, n (%) 5 (10.2) 4 (8.2) 2 (18.2) 2 (18.2) 1 (7.7) 0 2 (15.4) 2 (15.4) 0 0 TEAEs COVID - 19 Urinary tract infection

 

 

Secondary Endpoint - CADS ( Composite Alzheimer’s Disease Score) 7 -0.45 -0.35 -0.25 -0.15 -0.05 0.05 0.15 0.25 0.35 C h a n g e i n C o m p o s i t e A l z h e i m e r ' s D i s e a s e S c o r e 0 16 26 39 Weeks (relative to first infusion) Pooled Lomecel-B (25M x 4, 100M x 4)Pooled Lomecel-B (25M x 1, 25M x 4, 100M x 4) Lomecel-B (100M x 4)Lomecel-B (25M x 4) Lomecel-B (25M x 1)Placebo (Dose x 4) CADS components: ADAS-cog-13, CDR-SB, ADCS-ADL, Left Hippocampal Volume. Statistical significance is indicated as follows: * p<0.1, ** p<0.05, *** p<0.01, **** p<0.001. *p=0.091 *p=0.099 Statistically significant improvement at Week 39 in CADS was observed for the • Lomecel - B 25 M x 1 relative to Placebo (p= 0 . 091 ) • P ooled Lomecel - B Groups ( 25 M x 1 , 25 M x 4 , 100 M x 4 ) relative to Placebo (p= 0 . 099 ) p=0.091 p=0.099 Change in Composite Alzheimer’s Disease Score Increasing line/score indicates disease improvement

 

 

Secondary Endpoint – Left Hippocampal Volume* 8 • Statistically significant slowing of disease progression in left hippocampal volume at Visit 9 (Week 39) was observed in • Lomecel - B (25Mx1) treatment group relative to Placebo (p=0.015) • Pooled Lomecel - B treatment group (25Mx1, 25Mx4, 100Mx4) relative to Placebo (p=0.038) • At Visit 9 (Week 39), numerical slowing of disease worsening in left hippocampal volume was observed in all Lomecel - B treatment groups relative to Placebo. -0.075 -0.050 -0.025 0.000 0.025 C h a n g e i n L e f t H i p p o c a m p a l V o l u m e 0 16 26 39 Weeks (relative to first infusion) Pooled Lomecel-B (25M x 4, 100M x 4)Pooled Lomecel-B (25M x 1, 25M x 4, 100M x 4) Lomecel-B (100M x 4)Lomecel-B (25M x 4) Lomecel-B (25M x 1)Placebo (Dose x 4) Statistical significance is indicated as follows: * p<0.1, ** p<0.05, *** p<0.01, **** p<0.001. **p=0.048 **p=0.015 **p=0.038 *Left hippocampal volume was normalized by dividing the left hippocampal volume by the intracranial volume p=0.015 P=0.038 Change in Left Hippocampal Volume Increasing line/score indicates disease improvement

 

 

Secondary Endpoint – ADCS - ADL 9 • Statistically significant improvement at Visit 9 (Week 39) in ADCS - ADL was observed in the • Lomecel - B (100Mx4) treatment group relative to Placebo (p=0.040) • Pooled Lomecel - B treatment group (25Mx4, 100Mx4) relative to Placebo (p=0.034) • Pooled Lomecel - B treatment group (25Mx1, 25Mx4, 100Mx4) relative to Placebo (p=0.047) • A dose response in improvement in ADCS - ADL at Visit 9 (Week 39) was observed • All Lomecel - B treatment groups experienced greater improvement relative to Placebo -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 C h a n g e i n A D C S - A D L T o t a l S c o r e 0 16 26 39 Weeks (relative to first infusion) Pooled Lomecel-B (25M x 4, 100M x 4)Pooled Lomecel-B (25M x 1, 25M x 4, 100M x 4) Lomecel-B (100M x 4)Lomecel-B (25M x 4) Lomecel-B (25M x 1)Placebo (Dose x 4) Statistical significance is indicated as follows: * p<0.1, ** p<0.05, *** p<0.01, **** p<0.001. **p=0.040 **p=0.047 **p=0.034 p=0.040 p=0.047 p=0.034 Change in ADCS - ADL Total Score Increasing line/score indicates disease improvement

 

 

Secondary Endpoint – CDR - SB and ADAS - cog - 13 10 • CDR - SB - all Lomecel - B treatment groups experienced greater benefit than placebo (not statistically significant) At Visit 9 (Week 39) • ADAS - cog - 13 - No statistically significant differences were observed between any Lomecel - B dose and Placebo

 

 

• Primary endpoint met based on statistical and medical evaluation ▪ Lomecel - B is safe, well tolerated and comparable to Placebo ▪ Lomecel - B demonstrated benefit over Placebo by preventing deterioration in cognitive and atrophy signals ▪ We are encouraged by the finding from the CLEAR MIND study on both safety and secondary endpoints ▪ Additional exploratory and biomarker data will be available in a few weeks ▪ The results of CLEAR MIND study provide a strong foundation for further development in mild Alzheimer's disease patients' population Conclusions 11