UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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).
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Item 7.01 Regulation FD Disclosure.
On May 19, 2023, Candel Therapeutics, Inc. (the “Company”) will present a corporate presentation at the American Society of Gene & Cell Therapy (“ASGCT”) 26th annual meeting (the “Presentation”) entitled, “Safety and survival outcomes in recurrent high-grade glioma patients treated with CAN-3110, a first-in-class ICP34.5 expressing oncolytic HSV1.” The Presentation is posted on the “Media” section of the Company’s website at www.candeltx.com, and includes updates from the Company’s ongoing phase 1 clinical trial of CAN-3110.
A copy of the Presentation is attached as Exhibit 99.1 to this Item 7.01 of this Current Report on Form 8-K and incorporated herein by reference.
The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K are 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. The information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in any such filing.
Item 8.01 Other Events.
On May 19, 2023,the Company announced the release of new data from its ongoing phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma. The new data will be presented on May 19, 2023 at the ASGCT 26th annual meeting.
A copy of the press release (the “Press Release”) is filed as Exhibit 99.2 hereto and is incorporated herein by reference
Forward-looking Statements
The information in this Item 8.01 of this Current Report on Form 8-K and in the Press Release filed as Exhibit 99.2 hereto include certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, include key data readout milestones; expectations regarding the therapeutic benefit of its programs; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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99.1 |
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99.2 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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 thereunto duly authorized.
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Candel Therapeutics, Inc. |
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Date: May 19, 2023 |
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By: |
/s/ Paul Peter Tak |
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Paul Peter Tak, M.D., Ph.D., FMedSci |
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President and Chief Executive Officer |
Safety and survival outcomes in recurrent high-grade glioma patients treated with CAN-3110, a first-in-class ICP34.5 expressing oncolytic HSV1 Francesca Barone, MD, PhD Chief Scientific Officer, Candel Therapeutics, Inc. Exhibit 99.1
CAN-3110 a novel oncolytic virus engineered for enhanced activity and safety HSV-1 engineered for immunogenic potency and specificity ICP34.5-null viruses have shown safety, but replicate poorly CAN-3110: ICP34.5 expression under control of Nestin promoter Nestin overexpressed in gliomas (and tumors outside of the brain) Improves replication Provides tumor-specific oncolytic activity Designed for safety Disruption of ICP6 limits virus replication to dividing cells or cells with p16 tumor suppressor pathway defects Remains sensitive to anti-herpetic drugs Nestin provides tumor specificity
CAN-3110 induces tumor cell death and reprograms the highly immunosuppressive microenvironment of HGG Cold tumor Highly immunosuppressive TME Cancer cell proliferation Hot tumor Inflamed TME Cancer cell necrosis Tumor cell death Release of tumor antigens Expansion of T cell repertoire Activation of local microenvironment
Phase 1b clinical trial of CAN-3110 in recurrent high-grade glioma Primary Endpoints Safety Determine maximum tolerated dose Secondary Endpoints Immunological biomarkers MRI assessment of disease and progression free survival MRI alteration of permeability and flow at injection site Patients with recurrent high-grade glioma Lesions ≥ 1.0 cm Dose escalation (Cohort I-IX) Single stereotactic injection of CAN-3110 3+3 dose escalation 1 x 106 to 1 x 1010 PFU in half-log increments 30 patients dosed Dose expansion (Cohort X) 1 x 109 PFU 11 patients dosed PI: Dr. E. Antonio Chiocca (Brigham & Women’s) Pre-Administration of Cytoxan +1 x 108 PFU 3 patients dosed +1 x 109 PFU 6 patients dosed Repeat Dosing (up to 6) +1 x 108 PFU x 6 doses +1 x 109 PFU x 6 doses 12 patients targeted Arm A Arm B NCT03152318 Arm C
Patient demographics and baseline characteristics 41 unique patients were dosed; one patient was treated twice, in cohort IX and X A total of 50 unique patients * See below Arm A (n=41*) Arm B (n=9) Total (n=50*) Age, Median (range) 54 years (27 - 74) 54 years (41 - 70) 55 years (27 - 74) Sex, n (%) Female 21 (51%) 3 (33%) 24 (48%) Male 20 (49%) 6 (67%) 26 (52%) Race, n (%) White 38 (93%) 8 (89%) 46 (92%) Black or African American 1 (2%) 0 (0%) 1 (2%) Asian 2 (5%) 1 (11%) 3 (6%) Ethnicity, n (%) Non-Hispanic 40 (98%) 8 (89%) 48 (96%) Hispanic or Latino 0 (0%) 1 (11%) 1 (2%) Unknown 1 (2%) 0 (0%) 1 (2%) IDH Status, n (%) Wild-Type 32 (78%) 7 (78%) 39 (78%) Mutant 9 (18%) 2 (22%) 11 (25%) MGMT Status, n (%) Methylated 16 (39%) 2 (22%) 18 (36%) Unmethylated 23 (56%) 7 (78%) 30 (60%) Unknown 2 (5%) 0 (0%) 2 (4%) Grade, n (%) III 7 (17%) 0 (0%) 7 (14%) IV 34 (83%) 9 (100%) 43 (86%) KPS Score, Median (range) 90 (70 - 100) 90 (80 - 100) 90 (70 - 100)
CAN-3110 related SAEs in rHGG (arms A and B) Cohort (arm) Number of treated patients Dose Level (PFU) Number of patients with DLT Number of patients with related SAE Case # Time (days) 1 (A) 3 1x106 0 0 NA NA 2 (A) 3 3x106 0 0 NA NA 3 (A) 3 1x107 0 0 NA NA 4 (A) 3 3x107 0 0 NA NA 5 (A), 1 (B) 6 1x108 0 0 NA NA 6 (A) 3 3x108 0 0 NA NA 7 (A), 10 (A), 2 (B) 21 1x109 0 1 046(IDHmut) 2 8 (A) 3 3x109 0 1 033(IDHmut) 16 9 (A) 6 1x1010 0 0 NA NA TOTAL 50* 0 2 Time range (days) 2 to 16 DLT: dose limiting toxicity, SAE: serious adverse event * Total includes one patient who received two injections, one in cohort 9 (A) and one in cohort 10 (A) As of cutoff date 25 Apr 2023
Arm A (n=41) n (%) General disorders and administration site conditions Fever 3 (7%) Musculoskeletal and connective tissue disorders Muscle weakness 3 (7%) Nervous system disorders Seizure 3 (7%) Safety summary: related adverse events* (AEs) in rHGG Arm B (n=9) n (%) Nervous system disorders Edema Cerebral 1 (11%) Hemianopia 1 (11%) Hypoesthesia 1 (11%) * events manifesting in ≥5% of patients
No patients experienced a DLT in Cohorts I-X All patients (n=41) experienced at least 1 AE 27% of patients (n=11) experienced at least 1 related AE 59% of patients (n=24) experienced at least 1 serious AE Most Serious AEs: Edema Cerebral (n=8 [20%]) and Seizure (n=5 [12%]) 5% of patients (n=2) experienced at least 1 serious related AE 001-033: Grade 3 – Seizure, Cerebral hematoma 001-046: Grade 2 - Seizure, muscle weakness , facial paresis Most *TEAEs were Grade 1-3 Most common Grade 3 AEs include Edema Cerebral (n=8 [20%]), Seizure (n=5 [12%]) and Muscle weakness (n=5 [12%]). One patient experienced a grade 5 cardiac arrest, non-related No grade 4 AEs All patients (n=9) experienced at least 1 AE 11% of patients (n=1) experienced at least 1 related AE 001-060: Grade 2 – Edema cerebral, left leg numbness, left visual field defect 22% of patients (n=2) experienced at least 1 serious AE 001-061: Grade 3 – Edema cerebral, muscle weakness 001-065: Grade 3 – Cerebrospinal fluid leakage, left hemiparesis, pseudo-meningocele and muscle weakness No patient (n=0) experienced a serious related AE All *TEAEs were grade 1-3 Most common Grade 3 AEs include Muscle Weakness (n=2 [22%]) No grade 4 or 5 AEs Arm A (n=41*) Safety summary: adverse events in rHGG Arm B (n=9) * 41 unique patients were dosed; 00030 was treated twice, Cohort IX and X * Treatment Emergent Adverse Events (TEAEs)
Encouraging overall survival in rHGG after single injection (arm A) N = 30 Median overall survival: 11.8 months Cutoff date: 20 Apr 2023 Expected median overall survival: <6-9 months 41 unique patients were dosed; one patient was treated twice, in cohort IX and X A total of 50 unique patients
Overall survival data rHGG arm B confirms data in arm A N = 9 patients pretreated with cyclophosphamide Median overall survival: 12 months Cutoff date 20 Apr 2023 Expected median overall survival: <6-9 months
Day 56 Reduction in contrast area with no additional treatment Day 111 Patient back to work Baseline Clinical effect on injected tumor and uninjected tumor Day 168 Day 280 Day 0 Black hole within tumor image is injection site 106 PFU dose 56 YOM, IDH wild-type, MGMT partially methylated, right frontal mesial lesion initially treated with GTR, chemoradiation. Recurrences at two sites. Monotherapy activity of CAN-3110 in rHGG (arm A)
Durable response for 2Yrs after CAN-3110 in rHGG (arm A) Day -47 Tumor recurrence Day -30 2nd subtotal resection Day -262 Initial presentation Day -14 Rapid progression Day -259 Initial resection 61 YOF, IDH wild-type, MGMT methylated glioblastoma, right temporal lesion initially treated with surgery, chemoradiation and temozolomide CAN-3110 dose: 108 PFUs. Patient passed away as passenger in a motor vehicle accident on day 717. Day 91 Tumor recurrence with TIL Day 96 After resection, histology shows TILs Day 0 CAN-3110 Injection Day 630 No visible tumor Needle visible on MRI Initial lesion Tumor bed injection site
Continued improvement for >12Mos after CAN-3110 monotherapy (arm B) Day 0 CAN-3110 injection Day 64 Day 106 Pre-op Day -4 52 YO RH WF, IDH mutant, MGMT methylated grade IV astrocytoma (left frontal, invading corpus callosum in a butterfly fashion and lobulating into lateral and third ventricle). Recurrent disease, 1Yr after original resection. Enrolled in arm B: Cytoxan (24 mg/kg; day -2) & CAN-3110. Since injection KPS remains between 90 and 100, pt. independent at home with family, without other therapies. Day 180 Day 350 Initial lesion CAN-3110 Injection cavity Stable disease Day 280 Reduction in enhancement with tumor involution Cytoxan (day-2) Progressive reduction in enhancement Increased enhancement
Biomarker Analysis
Persistent HSV antigen expression associated with CD8+ T cell infiltration after CAN-3110 treatment Patient A (6 weeks post-HSV 10e6 PFUs) HSV1 Ag Day 253 Preoperative Intraoperative injection Anti HSV CD8+ Recurrence Patient B (9 mos post-HSV 10e9 PFUs) 13/27 patients presented positive oHSV antigen in post-injection samples collected in a range of 24 to 801 days post treatment
Injected lesion Uninjected lesion Uninjected lesion Pre-treatment Post-treatment* *8 Mos Persistent HSV antigen expression in uninjected lesion 8 Mos after CAN-3110 injection in multifocal rHGG HSV-1 Uninjected lesion
P<0.0001 P<0.0001 P<0.0005 P<0.0001 21/29 tumors p =0.0016 24/29 tumors p <0.0001 14/29 tumors CD8 CD4 CD20 Increased infiltration by immune cells at the site of the tumor after CAN-3110 treatment in rHGG Post-injection necrotic tumor areas surrounded by T cells anti HSV H&E 3 x107 PFU d 24 1 x108 PFU d 91 3 x107 PFU d 140 # necrosis; * immune cell infiltrate # * # * # * * # H&E
Changes in tumor microenvironment after CAN-3110 are associated with improved survival in rHGG 17 paired samples bioinformatic analyses by BostonGene, Inc.
Changes in protein biomarkers in peripheral blood after CAN-3110 injection in rHGG From 96 protein panel biomarkers, 53 showed statistically significant changes compared to baseline at the 1st or 2nd time points after treatment; those include IL-6, PTN, MMP12, CCL19, CD40L
T cell receptor (TCR) analysis interpretation tool Relationship between clonality and diversity/entropy
Increases in T cell density, entropy, and clonality are observed in long survivors after CAN-3110 injection Short survivor CAN-3110 injection Long survivors
Conclusions Treatment with CAN-3110 in rHGG is well tolerated with no dose-limiting toxicity observed Persistence of HSV antigen expression associated with tumor necrosis and increased immune cell infiltration after CAN-3110 injection in both injected and uninjected lesions Evidence of abscopal effect Increase in pro-inflammatory mediators after CAN-3110 injection in rHGG Immunological changes in the tumor microenvironment after CAN-3110 injection in rHGG are associated with improved survival Increases in T cell density, entropy, and clonality are observed in long survivors after CAN-3110 injection Next, we will evaluate the effects of repeat injections with CAN-3110, supported by the Break Through Cancer foundation
Acknowledgements Alexander Ling Isaac H. Solomon Ana Montalvo Landivar Hiroshi Nakashima Andres Santos Nafisa Masud Patrick Wen Keith Leigon David Reardon Sengupta Soma E. A. Chiocca Andrea Manzanera Maria Lucia Silva Polanco Garrett Nichols Paul Peter Tak
Exhibit 99.2
Candel Therapeutics Announces New Data from Ongoing Phase 1 Clinical Trial of CAN-3110 in Recurrent High-Grade Glioma at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting
NEEDHAM, Mass., May 19, 2023 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, today announced new data from an ongoing phase 1 investigator-sponsored clinical trial of its herpes simplex virus-1 (HSV-1) replication-competent viral immunotherapy candidate, CAN-3110, in patients with high-grade glioma that has recurred after standard of care (SoC) treatment. The data were presented today in an Oral Presentation Session at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) taking place in Los Angeles, CA and virtually from May 16 – 20, 2023.
“After one dose of CAN-3110, we observed encouraging responses in individual patients with recurrent high-grade glioma, including responses in both injected and uninjected lesions,” said Francesca Barone, MD, PhD, Chief Scientific Officer of Candel. “We are encouraged by the increased survival of treated patients in two independent cohorts observed to date. We believe the responses are notable, given that recurrent high-grade gliomas are fast-growing, spread quickly and are treatment-resistant.”
Dr. Barone continued, “Results demonstrated that CAN-3110 was well tolerated without dose-limiting toxicities and significantly increased the median overall survival rate to 12.0 months in nine patients from arm B. These findings support the median overall survival rate observed in 41 patients from arm A who received CAN-3110 and exceeded
the historical median overall survival rates of less than 6 to 9 months achieved by standard of care. In arm C, we look forward to investigating whether multiple doses of CAN-3110 can further increase survival rates for these patients who desperately need new treatment options.”
“We believe data from the first 50 patients with recurrent high-grade glioma who received a single intratumoral injection of CAN-3110 supports the notion that this approach is generally well tolerated and may provide clinical improvement and survival benefit,” said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. “Sadly these patients have extremely limited treatment options, which makes these data even more encouraging.”
Dr. Tak continued, “In arm C, we and our collaborators are studying a repeat dosing regimen of CAN-3110 for up to six injections over four months in patients with recurrent high-grade glioma to evaluate whether we can further improve our current results. CAN-3110 is designed to replicate specifically in tumor cells expressing Nestin. This specificity allows us to test this asset in the future in other indications that are characterized by Nestin expression, potentially allowing for a pipeline expansion opportunity into new diseases.”
Highlights from the Oral Presentation Session at ASGCT
An ongoing phase 1 clinical trial, which includes arms A, B, and C, is evaluating the safety and activity of CAN-3110 in patients with recurrent high-grade glioma who have experienced disease progression following prior treatment with SoC therapies. Based on historical clinical data, overall survival in this patient population is < 6-9 months. The Company previously announced data from arm A (n=41), which demonstrated that treatment with a single dose of CAN-3110 was generally well tolerated and resulted in median overall survival (mOS) rate of 11.6 months as of the data cutoff date on July 22, 2022. This has now been updated to 11.8 months as of the data cutoff date on April 20, 2023. New clinical data from arm B (n=9) and updated data from arm A demonstrated the following results as of the data cutoff date:
About CAN-3110 evaluated in the phase 1 clinical trial
CAN-3110 is a first-in-class HSV-1 viral immunotherapy candidate engineered to express one copy of the ICP34.5 gene under the transcriptional control of the Nestin-specific promoter. This modification is designed to largely restrict CAN-3110 replication and oncolytic activity to Nestin+ tumor cells. The phase 1 clinical trial is evaluating the safety and activity of CAN-3110 in patients with recurrent high-grade glioma who have experienced disease progression following prior treatment with SoC therapies.
This investigator-sponsored study is led by E. Antonio Chiocca, MD, PhD, Head of the Department of Neurosurgery at Brigham & Women’s Hospital and Professor at Harvard Medical School. The clinical trial comprises three arms. In arm A, 41 patients with recurrent high-grade glioma were treated by a single intratumoral injection of CAN-3110 (dose ranging from 1x106 plaque forming units (pfu) to 1x1010 pfu), including nine patients with multifocal/multicentric, deep or bilateral tumors associated with poor survival. After showing tolerability of this regimen without dose-limiting toxicity, patients in arm B (n=9) were treated with a single high dose of cyclophosphamide (24 mg/kg), two days before CAN-3110 injection at doses of 1 x 108 pfu (n=3) and 1 x 109 pfu (n=6). The rationale is based on findings in mouse models, where cyclophosphamide improved viral persistence in injected tumors. In arm C, supported by the Break Through Cancer foundation, two cohorts of 12 patients with recurrent high-grade glioma will receive up to six injections of CAN-3110 over a four-month period.
Details of the oral presentation are as follows:
About Candel Therapeutics
Candel is a clinical stage biopharmaceutical company focused on developing viral immunotherapies that elicit a systemic anti-tumor immune response to help patients fight cancer. Candel’s engineered viruses are designed to induce immunogenic cell
death through direct viral-mediated cytotoxicity in cancer cells, thus releasing tumor neo-antigens while creating a pro-inflammatory microenvironment at the site of injection. Candel has established two clinical stage viral immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform and CAN-3110 is the lead product candidate from the HSV platform. Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.
For more information about Candel, visit www.candeltx.com.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, include key data readout milestones; expectations regarding the therapeutic benefit of its programs; and expectations regarding cash runway and expenditures. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, and strategic plans for the Company’s business and product candidates, and other risks identified in the Company’s SEC filings, including the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC, and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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