Y-mAbs Therapeutics, Inc. Announces Closing of Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

On February 22, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the closing of its public offering of 2,804,878 shares of its common stock, at a public offering price of $41.00 per share, which includes the exercise in full of the underwriters’ option to purchase 365,853 additional shares of common stock (Press release, Y-mAbs Therapeutics, FEB 22, 2021, View Source [SID1234575385]). The aggregate gross proceeds to Y-mAbs, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, were approximately $115 million. All of the shares of common stock were offered by the Company. Y-mAbs’ common stock is listed on The Nasdaq Global Select Market under the ticker symbol "YMAB."

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J.P. Morgan, Morgan Stanley and BofA Securities acted as the joint book-running managers for the offering. H.C. Wainwright & Co. and Kempen & Co acted as lead co-managers for the offering.

A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the Securities and Exchange Commission ("SEC") on February 16, 2021. A final prospectus supplement relating to the offering was filed with the SEC on February 18, 2021. Copies of the final prospectus supplement relating to the offering are available on the SEC’s website at www.sec.gov. The final prospectus supplement and prospectus relating to the offering may be obtained from: J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, or by telephone at (866) 803-9204; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014 or BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by emailing [email protected].

The shares of common stock described above are being offered by Y-mAbs pursuant to its shelf registration statement on Form S-3 (Reg. No. 333-234034), including a base prospectus, that was filed with the SEC on October 1, 2019 and declared effective by the SEC on October 15, 2019. The securities are being offered only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. This press release shall 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Vaccinex Announces Licensing of Anti-CCR8 Antibody to Surface Oncology

On February 22, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that Surface Oncology will be exercising its option to license the anti-CCR8 antibody discovered via Vaccinex’s ActivMAb antibody discovery and novel viral display platform (Press release, Vaccinex, FEB 22, 2021, View Source [SID1234575384]). The antibody, SRF114, is a fully human IgG1 anti-CCR8 antibody that selectively depletes immuno-suppressive tumor T regulatory cells (Tregs) while sparing peripheral Tregs. The terms of agreement with Surface Oncology provided that Surface Oncology pay technology access and licensing fees in addition to research funding, and that Vaccinex will qualify for development milestone payments and royalties.

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"We are thrilled to continue building on the recent success of our ActivMAb platform with the announcement of our licensing deal with Surface Oncology," said Ernest Smith, chief scientific officer of Vaccinex. "The presence of Treg in human tumors is associated with resistance to immunotherapy and blocking CCR8 has been demonstrated to potentiate inhibition of tumor growth in animal studies. Data presented at SITC (Free SITC Whitepaper) 2020 demonstrated that SRF114 specifically binds to human CCR8 and induces Treg destruction through antibody-dependent cellular cytotoxicity. We are pleased to have played a part in the development of this promising drug candidate and look forward to following continuing development of SRF114 and further interactions with Surface Oncology."

About ActivMAb
ActivMAb was developed by Vaccinex and is a proprietary mammalian cell-based antibody discovery and novel viral display platform. The technology has multiple applications, including discovery of antibodies specific for complex membrane antigens, discovery of antibodies with optimized developability, and protein optimization for expression and activity. Its novel capabilities enable selection of unique antibody drugs against difficult high-value targets, including multi-pass membrane proteins against which small molecule drugs have demonstrated low efficacy or high toxicity.

Syros to Participate in Upcoming Investor Conferences in March

On February 22, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that members of its management team will participate in panel discussions and present a corporate overview at upcoming investor conferences. Details are as follows (Press release, Syros Pharmaceuticals, FEB 22, 2021, View Source [SID1234575383]):

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Cowen and Company 41st Annual Health Care Conference
Date: Monday, March 1
Panel Title: Novel Oncology Targets
Panel Time: 1:20 p.m. ET

33rd Annual Roth Conference
Date: Monday, March 15
Panel Title: Navigating Clinical Development in RARE Hematologic & Inflammatory Disease
Panel Time: 10:00 a.m. ET

Oppenheimer 31st Annual Healthcare Conference
Date: Tuesday, March 16
Presentation Time: 8:40 a.m. ET

Live webcasts of the Roth and Oppenheimer presentations will be available on the Investors & Media section of the Syros website at www.syros.com. Archived replays of the webcasts will be available for approximately 30 days following each presentation.

FDA Approves Libtayo® (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-small Cell Lung Cancer with PD-L1 Expression of ?50%

On February 22, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi reported that the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test (Press release, Regeneron, FEB 22, 2021, View Source [SID1234575382]). Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.

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"The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease," said Naiyer Rizvi, M.D., Price Family Professor of Medicine, Director of Thoracic Oncology and Co-director of Cancer Immunotherapy at Columbia University Irving Medical Center, as well as a steering committee member of the trial. "Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation. This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice."

This is the third approval for Libtayo and follows a Priority Review by the FDA, which is reserved for medicines that represent significant improvements in safety or efficacy in treating serious conditions. Earlier this month, Libtayo was approved as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, with full approval granted for locally advanced disease and accelerated approval granted for metastatic disease. In 2018, Libtayo was the first systemic treatment approved for adults with advanced cutaneous squamous cell carcinoma (CSCC) that is locally advanced or metastatic and who are not candidates for curative surgery or curative radiation. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo.

"Libtayo has demonstrated an impressive level of efficacy in advanced NSCLC with at least 50% PD-L1 expression in its pivotal trial," said Ahmet Sezer, M.D., Professor in the Department of Medical Oncology at Başkent University in Adana, Turkey and a trial investigator. "As published in The Lancet, in a prespecified analysis in the subset of patients proven to have PD-L1 expression of at least 50%, Libtayo reduced the risk of death by 43% compared to chemotherapy. This was achieved with a greater than 70% crossover rate to Libtayo following disease progression on chemotherapy, as well as the largest population of patients with pretreated and clinically stable brain metastases among advanced NSCLC pivotal trials to date."

The data supporting the Libtayo approval are based on an analysis of 710 patients who were randomized to receive treatment in a Phase 3 trial; eligible patients were intended to have PD-L1 expression of ≥50%. In this patient population, Libtayo reduced the risk of death by 32% compared to chemotherapy, with additional efficacy results as follows:

Endpoints

Libtayo

350 mg every 3 weeks

N=356

Chemotherapy

N=354

Overall Survival (OS)

Median (95%
Confidence Interval
[CI])a

22 months

(18 months to not evaluable)

14 months

(12 to 19 months)

Hazard ratio (95% CI)b

0.68 (0.53-0.87)

p-value

0.0022

Progression-free Survival (PFS) per Blinded Independent Central Review (BICR)

Median (95% CI)a

6.2 months

(4.5 to 8.3 months)

5.6 months

(4.5 to 6.1 months)

Hazard ratio (95% CI)b

0.59 (0.49-0.72)

p-value

<0.0001

a Based on Kaplan-Meier method
b Based on stratified proportional hazards model

Due to PD-L1 testing issues, an additional prespecified analysis was performed in 563 patients with proven PD-L1 expression of ≥50%, according to the FDA-approved assay, and is described in the updated labeling of the FDA-approved assay (and also recently published in The Lancet). This analysis showed that Libtayo reduced the risk of death by 43% compared to chemotherapy, with additional efficacy results as follows:

Endpoints

Libtayo

350 mg every 3 weeks

N=283

Chemotherapy

N=280

OS

Median (95% CI)a

not reached

(18 months to not evaluable)

14 months

(11 to 18 months)

Hazard ratio (95% CI)b

0.57 (0.42-0.77)

p-value

0.0002

PFS

Median (95% CI)a

8 months

(6 to 9 months)

6 months

(5 to 6 months)

Hazard ratio (95% CI)b

0.54 (0.43-0.68)

p-value

<0.0001

NOTE: The analysis was conducted in a subset of the randomized population that excluded 147 patients whose tumors could not be retested or were later found to have <50% PD-L1 expression.
a Based on Kaplan-Meier method
b Based on stratified proportional hazards model

Safety was assessed in 355 patients in the Libtayo group (median duration of exposure: 27 weeks; range: 9 days to 115 weeks) and 342 patients in the chemotherapy group (median duration of exposure: 18 weeks; range: 18 days to 87 weeks). Adverse reactions that occurred more commonly in the Libtayo group and in at least 10% of patients were rash (15% Libtayo, 6% chemotherapy) and cough (11% Libtayo, 8% chemotherapy). The most frequent serious adverse reactions in at least 2% of patients were pneumonia (5% Libtayo, 6% chemotherapy) and pneumonitis (2% Libtayo, 0% chemotherapy). Treatment was permanently discontinued due to adverse reactions in 6% of Libtayo patients; adverse reactions resulting in permanent discontinuation in at least 2 patients were pneumonitis, pneumonia, ischemic stroke and increased aspartate aminotransferase. No new Libtayo safety signals were observed.

"We developed Libtayo to deliver clinically meaningful benefits to patients suffering from a diverse range of cancers and to establish a foundation for potential future immunotherapy combinations. Today’s approval continues to support this vision," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "Libtayo has already changed the treatment paradigm for certain patients with advanced cutaneous squamous cell carcinoma and is poised to do the same for advanced basal cell carcinoma. Now, Libtayo has the opportunity to make a meaningful difference for the many U.S. patients battling advanced non-small cell lung cancer. Libtayo is being investigated in a variety of settings, and we hope to share updates later this year on our pivotal trials in cervical cancer and in combination with chemotherapy in advanced non-small cell lung cancer."

Lung cancer is the leading cause of cancer death worldwide. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed worldwide and in the U.S, respectively. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages and an estimated 25% to 30% of cases expected to test positive for PD-L1 in ≥50% of tumor cells.

"With this third approval for Libtayo, we are proud to deliver on our ambition to bring our PD-1 inhibitor to patients in need with difficult-to-treat cancers, such as advanced non-small cell lung cancer," said Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi. "As the leading cause of cancer deaths globally, the need for additional therapeutic options in advanced NSCLC is clear. Libtayo allows physicians to further optimize treatment of these patients whose tumors have high expression of PD-L1. We thank all of the trial investigators, patients and their caregivers who helped make this milestone possible."

About the Phase 3 Trial Supporting Approval
The open-label, randomized, multi-center Phase 3 trial, called EMPOWER-Lung 1, was designed to investigate the first-line treatment of Libtayo monotherapy compared to platinum-doublet chemotherapy in patients with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1 aberrations. PD-L1 expression was confirmed using the Agilent Dako PD-L1 IHC 22C3 pharmDx kit. The primary endpoints were OS and PFS, and secondary endpoints included overall response rate, duration of response and quality of life.

The trial randomized 710 patients with either previously untreated metastatic NSCLC (Stage IV) or locally advanced NSCLC (Stage IIIB/C) who were not candidates for surgical resection or definitive chemoradiation or who had progressed after treatment with definitive chemoradiation. Enrolled patients included those with disease characteristics frequently underrepresented in pivotal advanced NSCLC trials. Among them, 12% had pre-treated and clinically stable brain metastases and 16% had locally advanced NSCLC that was not a candidate for definitive chemoradiation.

Importantly, patients whose disease progressed in the trial were able to change their therapy: those assigned to chemotherapy were allowed to crossover to Libtayo treatment following disease progression, while those assigned to Libtayo monotherapy were allowed to combine Libtayo treatment with 4 to 6 cycles of chemotherapy following disease progression. There was a >70% crossover rate to Libtayo following disease progression on chemotherapy.

About Libtayo
Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

Across all of its approved indications, the recommended dose of Libtayo is 350 mg administered as an intravenous infusion over 30 minutes every three weeks, until disease progression or unacceptable toxicity. Libtayo is available as a single-dose 350 mg vial.

In the U.S., the generic name for Libtayo in its approved indication is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the FDA. Outside of the U.S., the generic name for Libtayo in its approved indication is cemiplimab.

Libtayo was invented using Regeneron’s VelocImmune technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. When Regeneron’s co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically-humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Yancopoulos and his team have used VelocImmune technology to create multiple antibodies including Dupixent (dupilumab), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb), Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) and Regeneron’s antibody cocktail for COVID-19, which was recently granted Emergency Use Authorization (EUA) in the U.S.

About the Libtayo Development Program
The European Medicines Agency is assessing regulatory submissions for Libtayo in advanced NSCLC with ≥50% PD-L1 expression and locally advanced BCC following treatment with an HHI. Decisions by the European Commission on these submissions are expected by mid-2021.

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. In skin cancer, this includes trials in adjuvant and neoadjuvant CSCC. Libtayo is also being investigated in pivotal trials in NSCLC (in combination with chemotherapy) and cervical cancer, as well as in trials combining Libtayo with either conventional or novel therapeutic approaches for both solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is Libtayo?
Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI.

Libtayo is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that has spread (metastatic BCC) and have received treatment with a hedgehog pathway inhibitor (HHI), or cannot receive treatment with a HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.

Libtayo is a prescription medicine used to treat people with a type of lung cancer called non-small cell lung cancer (NSCLC). Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR"," ALK "or "ROS1" gene.

It is not known if Libtayo is safe and effective in children.

What is the most important information I should know about Libtayo?
Libtayo is a medicine that may treat certain cancers by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, or chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), or bleeding or bruising more easily than normal
Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite
Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Libtayo. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling.
Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Libtayo. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Libtayo if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Libtayo can harm your unborn baby
Females who are able to become pregnant:
Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.

Pulse Biosciences Reports Fourth Quarter and Full Year 2020 Financial Results

On February 22, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing its Nano-Pulse Stimulation (NPS) technology, reported financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Pulse Biosciences, FEB 22, 2021, View Source [SID1234575381]).

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Recent Highlights

Received U.S. Food and Drug Administration (FDA) clearance for the CellFX System for dermatologic procedures requiring ablation and resurfacing of the skin
Received CE mark approval for the CellFX System
Initiated the CellFX System Controlled Launch program in the U.S. and Europe, including system implementations and completion of the first procedures performed by participating Key Opinion Leader (KOL) aesthetic dermatologists
Continued preparation to make an FDA 510(k) submission for a sebaceous hyperplasia (SH) specific indication for the CellFX System as early as the end of the first quarter of 2021
Enrolled and treated the first patients in an IDE pivotal comparison study to evaluate the treatment of cutaneous non-genital warts using the CellFX System
"Our diligent efforts throughout 2020 resulted in regulatory clearances for the CellFX System in the U.S. and Europe. We believe these achievements highlight the safety and efficacy of our CellFX System for use in aesthetic dermatology. Along with our clinical investigators, we have built a strong foundation from which we intend to expand CellFX System indications for use, first in aesthetic dermatology and subsequently for other applications over time, as we execute on our stepwise regulatory strategy," said Darrin Uecker, President and CEO of Pulse Biosciences. "The detailed and thoughtful preparation by our team has enabled the immediate implementation of our Controlled Launch program of the CellFX System integrated with CellFX CloudConnect services. In both the U.S. and in Europe, we now have KOLs performing CellFX procedures. This measured approach is our top focus in 2021 and will lay the groundwork for long term adoption of the CellFX System with CellFX CloudConnect and growth for Pulse Biosciences."

Fourth Quarter 2020 Results

Cash, cash equivalents and investments totaled $20.5 million as of December 31, 2020, compared to $29.6 million as of September 30, 2020. Cash used in the fourth quarter of 2020 totaled $9.1 million. Excluding net proceeds received in our June 2020 rights offering, cash use for the full year ended December 31, 2020 totaled $34.6 million, compared to $34.2 million for the full year 2019.

Operating expenses for the three months ended December 31, 2020 were $13.8 million, compared to $13.9 million for the prior year period. Fourth quarter 2020 operating expenses included stock-based compensation expense of $2.4 million, compared to $3.5 million in the fourth quarter of 2019.

Operating expenses for the twelve months ended December 31, 2020 were $50.0 million, compared to $48.0 million for the prior year period. Stock-based compensation expense for the twelve months ended December 31, 2020 was $10.1 million, compared to $11.3 million in the prior year period. The increase in operating expenses was primarily driven by the expansion of operational infrastructure and increased headcount to support preparations for commercialization.

Net loss for the three months ended December 31, 2020 was ($13.8) million in line with the same ($13.8) million for the three months ended December 31, 2019. Net loss for the twelve months ended December 31, 2020 was ($49.9) million, compared to ($47.0) million for the twelve months ended December 31, 2019.

Impact of COVID-19

The COVID-19 pandemic had minimal impact on our operations in the fourth quarter of 2020. Product development, execution of clinical trials, regulatory timelines and controlled commercial launch have not been materially affected at this time but due to the uncertain scope and duration of the pandemic, future impact to our operations and financial results cannot be reasonably estimated.

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call today, February 22, 2021 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source