On February 10, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported consolidated financial results for the first quarter of fiscal 2022, ended December 31, 2021.

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"Applied DNA had an excellent start to fiscal 2022 as we continued to capitalize on the demand for enterprise-scale COVID-19 testing while making meaningful progress in developing LinearDNA, our long-term, biotherapeutic growth platform," stated Dr. James A. Hayward, president and CEO. "Following record-high revenues in fiscal 2021, we are pleased to deliver another quarter of record revenues. Growth in our top-line was driven principally by higher demand for COVID-19 testing that was further catalyzed by the emergence of the Omicron variant, and due to the final shipment of molecular taggant under a previously awarded $1.6 million order to tag textile fibers.

"The first quarter was also noteworthy for progress in positioning our LinearDNA platform as an alternative to plasmid DNA (pDNA) in the manufacture of nucleic acid-based therapeutics," continued Dr. Hayward. "Data generated from the ongoing animal clinical trials of our initial LinearDNA therapeutic candidate, our vaccine against SARS-CoV-2 in domestic felines and ferrets, as well as the application of LinearDNA constructs in a non-viral CAR-T manufacturing system alongside a European Union-based client, have been highly encouraging. With clinical development pipelines industrywide focused on therapies that require DNA for production and growing interest in pDNA alternatives with early- to late-stage manufacturing capacity that can allow therapeutic programs to evolve efficiently, we believe we are building a very compelling case for LinearDNA as a viable alternative to pDNA."

Continued Dr. Hayward, "Looking ahead, we believe we are well-positioned for continued growth as investments in our clinical testing and services offering continue to yield growth. Testing momentum continued into the second quarter and contributed most of unaudited January revenues of approximately $2.0 million, and we anticipate higher demand from our largest testing client to ensure a safe start to the Spring semester for a larger on-campus population. We are also broadening the base of prospective testing clients nationwide upon authorization of our Linea 2.0 COVID-19 Assay (the "Linea 2.0 Assay") and Linea Unsupervised At-Home Sample Collection Kit (the "Collection Kit") EUA request. Existing clients have also expressed an interest in the Collection Kit as it enhances safeCircle’s operational flexibility to end-users. Longer-term, we are working to ensure that our investments to support COVID-19 testing serve as the foundation for a stable and profitable clinical lab business based on a more diversified offering of molecular and genetic tests that parallel the therapeutic objectives for LinearDNA.

"The next steps for our LinearDNA platform center on initiatives to optimize the design and delivery of LinearDNA, including the deployment of a Lipid Nanoparticle (LNP) system that we believe makes our platform more attractive to potential contract development and manufacturing company (CDMO) customers and enhances the development of our therapeutic pipeline. Our clinical development priorities align with our contract research organization (CRO) customers as we seek to mature these relationships into CDMO customers. With nearly one-half of our customers utilizing LinearDNA to manufacture preclinical CAR-T cells, we are working under the auspices of European Medicines Agency regulations with a European Union-based customer to define the first-ever Phase 1 LinearDNA CAR T clinical trial. Another substantial portion of our customers use LinearDNA as a template to manufacture preclinical mRNA therapeutics. Thanks to the success of COVID-19 vaccines, we believe the regulatory pathway for mRNA-based vaccines and therapeutics is well established, and developers are pursuing mRNA therapeutics for numerous indications beyond COVID-19. We believe that LinearDNA is well suited to supplant pDNA as the template for in vitro transcription, the process by which mRNA therapeutics are manufactured. In parallel, we expect to advance our veterinary COVID-19 vaccine candidate for its clinical data, its potential commercial utility, and its value as the prelude to LinearDNA vaccines for humans."

First Quarter Fiscal 2022 Financial Highlights:

Revenues increased 158% for the first quarter of fiscal 2022 to $4.2 million, compared with $1.6 million reported in the same period of the prior fiscal year and increased 37% from $3.0 million for the fourth quarter of fiscal 2021. The increase in revenues year-over-year was due primarily to an increase in clinical laboratory service revenues from our safeCircle COVID-19 testing platform of $2.4 million. In addition, product revenues increased by $276 thousand due mainly to an increase in sales of DNA concentrate of approximately $308 thousand to protect a textile supply chain offset by a decrease of approximately $52 thousand in sales of our Linea 1.0 COVID-19 Assay Kit.
Gross profit for the three months ended December 31, 2021, was $1.1 million, or 27%, compared with $1.1 million and 68% for the same period in the prior fiscal year. The decline in gross margin was primarily the result of a higher portion of our clinical laboratory service revenues coming from the testing contracts where we also provide and staff the test collection centers, as these contracts have higher costs associated with them compared with our surveillance testing contracts. The Company believes that gross margin will improve with the decrease in COVID-19 positivity rates as sample pooling returns, and, if sample numbers remain at the higher levels recorded by safeCircle for January 2022, the Company expects enhanced absorption of fixed costs for the collection centers.
Total operating expenses increased to $5.7 million for the first quarter of fiscal 2022, compared with $4.1 million in the prior-year quarter. The year-over-year increase is primarily attributable to an increase in stock-based compensation expense of approximately $1.1 million relating primarily to officer stock option grants that vested immediately, as well as to the annual non-employee board of director grant that vests one year from the date of the grant. To a lesser extent, the increase was attributable to an increase in Research and Development expenses of $316 thousand.
Net loss applicable to common stockholders for the first quarter of fiscal 2022, was $4.7 million, or $0.63 per share, compared with a net loss of $4.8 million, or $0.88 per share, for the prior-year quarter.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.7 million and negative $2.4 million for the first quarters of fiscal 2022 and 2021, respectively. See below for information regarding non-GAAP measures.
Cash and cash equivalents stood at $2.7 million on December 31, 2021, compared with $6.6 million as of September 30, 2021.
First Quarter Fiscal 2022 Conference Call Information
The Company will hold a conference call and webcast to discuss its first quarter fiscal 2022 financial results today, Thursday, February 10, 2022, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

To Participate:

Participant Toll Free:1-844-887-9402
Participant Toll: 1-412-317-6798
Please ask to be joined to the Applied DNA Sciences call
Live and Replay of webcast: View Source

Telephonic replay (available 1 hour following the conclusion of the live call through February 17, 2022):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 2723913
Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

Information about Non-GAAP Financial Measures
As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On February 10, 2022 Indapta Therapeutics, Inc., a privately held biotechnology company developing an NK (natural killer) cell therapy platform for the treatment of blood and solid tumor cancers, reported it has appointed Mark W. Frohlich, M.D., chief executive officer and raised over $50 million in Series A financing and commitments co-led by RA Capital Management, LP, Vertex Ventures HC and Leaps by Bayer, the impact investment arm of Bayer AG (Press release, Indapta Therapeutics, FEB 10, 2022, View Source [SID1234607992]). The Myeloma Investment Fund, the venture philanthropy subsidiary of the Multiple Myeloma Research Foundation, and Lonza also participated in the round. In connection with the financing, Laura Stoppel, Ph.D., principal at RA Capital Management, LP, Lori Hu, managing director at Vertex Ventures HC, and Fabio Pucci, Ph.D., senior director of venture investments health at Leaps by Bayer, joined Indapta’s board of directors.

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Dr. Frohlich, who also joined the board of directors, succeeds founding chief executive officer and co-founder Guy DiPierro, who has taken on the position of chief strategy officer.

The company will use the proceeds of the financing to grow the team and continue to advance its universal, allogeneic NK cell platform toward an Investigational New Drug Application (IND) and clinical trials. The company’s platform involves the isolation and expansion of a subset of NK cells known as G-NK cells, which have increased potency relative to conventional NK cells. Because the G-NK cells have very active antibody-dependent cellular cytotoxicity, they have the potential to provide substantial clinical benefit to patients when used in combination with monoclonal antibodies. Indapta’s G-NK cells are isolated from healthy donors and do not require genetic engineering, so they can serve as an off-the-shelf treatment that can overcome the cost and inconsistency of autologous T-cell therapies.

Dr. Frohlich has more than 25 years of experience developing cellular immunotherapies to treat cancer. He previously served as executive vice president of portfolio strategy at Juno Therapeutics, which developed the FDA-approved CAR T-cell therapy Breyanzi for large B-cell lymphoma, until the company was sold to Celgene, now part of Bristol Myers Squibb. Before Juno, Dr. Frohlich was chief medical officer and executive vice president at Dendreon Corporation, a pioneer in the development of cellular immunotherapy. At Dendreon, he led the clinical team responsible for the development and U.S. and European regulatory approval of PROVENGE, one of the first commercially available cancer immunotherapies.

"Mark is perfectly suited to lead Indapta as we move our unique G-NK cell therapy closer to clinical trials in patients with multiple myeloma and lymphoma," said Ronald Martell, co-founder and chairman of the board. "His biopharma management pedigree, successful drug development track record and scientific acumen, together with our Series A financing from such an experienced syndicate of investors, will accelerate our ability to bring this innovative therapy to patients. We look forward to Guy’s continued contributions as he transitions to the role of chief strategy officer."

Before joining Dendreon, Dr. Frohlich served as vice president and medical director at Xcyte Therapies, where he led the clinical development program for an autologous activated T-cell therapy to treat cancer. Earlier in his career, he was an assistant adjunct professor of hematology/oncology at the University of California, San Francisco, where he specialized in urologic oncology and conducted laboratory, translational and clinical research. Dr. Frohlich earned a B.S. in electrical engineering and economics from Yale College and an M.D. from Harvard Medical School. At UCSF, he served as chief resident in medicine and completed a fellowship in hematology/oncology and a Howard Hughes postdoctoral fellowship. Dr. Frohlich has served as a strategic advisor to several early-stage immuno-oncology and cell therapy companies and currently serves on the boards of NEUVOGEN and Bioeclipse Therapies.

"I joined Indapta because I believe its NK cell platform is truly differentiated and its preclinical data is particularly compelling. I’m excited to bring this off-the-shelf cell therapy to the clinic, where we have the potential to demonstrate it can benefit patients without the toxicities associated with currently approved cell therapies," said Dr. Frohlich. "I look forward to applying everything I’ve learned over the past two decades to develop this novel therapy."

SVB Leerink acted as Indapta’s exclusive financial advisor for the Series A financing.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Indapta’s G-NK Cell Therapy

Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody (mAb) therapy in multiple cancers. G-NK cells are a specific and potent subset of NK (natural killer) cells with specialized anti-tumor activity resulting from an epigenetic change rather than engineering. Indapta has further enhanced G-NK cells via specific G-NK cell subset selection and its proprietary manufacturing process, which, when combined, produce a G-NK cell therapy that demonstrates higher efficacy, persistence and enhanced cryopreservation.

When a mAb binds to the tumor target and Indapta’s G-NK cell therapy, it initiates the release of dramatically more cancer-killing compounds than conventional NK cells, allowing for increased efficacy and potentially less frequent dosing. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell banked product with low variability. In vivo studies have demonstrated the safety and efficacy of Indapta’s G-NK cell therapy.

Indapta is partnering with Lonza, a world-leading cell therapy manufacturer, to manufacture G-NK cells for use in clinical trials. Indapta will leverage Lonza’s process development capabilities and expertise to ensure robust, reproducible and scalable clinical good manufacturing processes (cGMP).

On February 10, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, reported the first published report of real-world experience utilizing the antegrade approach for Jelmyto (mitomycin) for pyelocalyceal solution administration in the Journal of Urology online on February 7, 2022 (Press release, UroGen Pharma, FEB 10, 2022, View Source [SID1234607961]). This report provides a stepwise treatment approach to low-grade Upper Tract Urothelial Cancer (LG UTUC) from initial ureteroscopy to nephrostomy placement, Jelmyto administration, and eventual nephrostomy removal.

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"While Jelmyto is approved for both retrograde and antegrade instillation, the instructions for administration address retrograde instillation, and this is the first time that data on antegrade instillation has been documented in a clinical setting for this chemoablative therapy," says Katie Murray, DO, Division of Urology, Department of Surgery, University of Missouri School of Medicine, Columbia, MO. "This report showed that antegrade instillation provided a well-tolerated and effective method of Jelmyto administration. In our experience we did not see a negative impact on patient comfort. Of note, our experience with antegrade administration in this analysis suggests that this approach, which minimizes manipulation of the ureter during instillation, may help protect against stricture formation which has been associated with repetitive instrumentation of the upper urinary tract. Given the potential benefits of antegrade versus retrograde administration of Jelmyto, we now have a replicable protocol to follow for antegrade administration using a nephrostomy tube."

In both retrograde and antegrade approaches, Jelmyto can be administered as an outpatient procedure in the clinic. Retrograde administration requires administration by a physician via a ureteral catheter, requiring fluoroscopic guidance. Antegrade administration may be performed by trained nursing professionals under clean rather than sterile conditions and does not require fluoroscopy after a nephrostogram confirms placement at the first instillation.

"Choosing the optimal treatment modality for administration of Jelmyto is very important and can have significant implications for successful treatment and recovery," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "Dr. Murray and her colleagues offer practical guidance for antegrade administration of Jelmyto, which can help reduce some of the complexity stakeholders may experience using retrograde administration."

About the Study

This single-center retrospective study reports the investigator’s technique for antegrade administration along with early outcomes from a cohort of eight patients who have undergone treatment with Jelmyto via nephrostomy tube. All patients underwent follow-up ureteroscopy with complete response in four patients. Three patients reported five adverse events. One patient had two grade-one adverse events (hematuria and fatigue); one patient had a grade-two adverse event (rash requiring oral medication, requiring one week delay of treatment); and one patient had a grade-one adverse event (a palmar rash) and a grade-three adverse event (ureteral stricture). The ureteral stricture was found in the mid-ureter at follow up ureteroscopy and required laser incision. There were no other delays in therapy. In the post hoc review, there were no other ureteral strictures.

The median follow-up was seven months after last instillation (range six weeks – 14 months). At first follow-up ureteroscopy, four patients had a complete response, four patients had a partial response, one of whom (with a history of low-grade bladder cancer) also had a bladder tumor. Four of the seven patients who have had more than one surveillance ureteroscopy had an initial complete response. At four and 14 months, two patients continue to show no evidence of disease. Two patients had a recurrence at 13 and 14 months. All patients with an initial partial response who had a follow-up ureteroscopy underwent complete endoscopic tumor ablation. One patient who could not be completely resected during their pre-instillation ureteroscopy demonstrated partial response to Jelmyto that enabled residual disease to be resected with durable response at five months after last ablation. To date, no patient has required kidney removal. Aside from the patient with bladder tumor at first ureteroscopy, no patient has experienced tumor recurrence in the bladder.

There is a need for larger studies with longer follow-up to study more conclusively any potential advantages of antegrade Jelmyto administration when compared to retrograde instillation. Despite these limitations, this study offers a replicable protocol for antegrade administration of Jelmyto.

About LG UTUC

LG UTUC is a rare disease managed by endoscopic methods and radical nephroureterectomy. Endoscopic resection and laser ablation attempt to preserve the kidney, though there is a high risk of recurrence that may eventually necessitate removal of the kidney. Although kidney removal is the gold standard for treatment of high-grade UTUC, it may be over-treatment in LG UTUC, as kidney removal offers similar five-year survival as kidney-sparing procedures but is associated with significant morbidity. Jelmyto is efficacious as a primary chemoablative therapy in patients with LG UTUC.

About Jelmyto

Jelmyto (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG UTUC in adults. It is recommended for primary treatment of biopsy-proven LG UTUC in patients deemed appropriate candidates for renal-sparing therapy. Jelmyto is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.

Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.

are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

On February 10, 2022 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the 11th Annual SVB Leerink Global Healthcare Conference on Friday, February 18, 2022 at 3:00 p.m. ET (Press release, Regulus, FEB 10, 2022, View Source [SID1234607977]).

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A live webcast of the presentation will be available under "Events and Presentations" through the investor relations section of the Company’s website at www.regulusrx.com. A replay of the webcast will be archived for 90 days following the presentation date.

On February 10, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported Gaurav Shah, M.D., Chief Executive Officer, will participate in a fireside chat at the virtual 11th Annual SVB Leerink Global Healthcare Conference on Wednesday, Feb. 16 at 10 a.m. ET (Press release, Rocket Pharmaceuticals, FEB 10, 2022, View Source [SID1234607993]).

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A live audio webcast of the presentation will be available under "Events" in the Investors section of the Company’s website at View Source The webcast replay will be available on the Rocket website following the conference.