On March 30, 2021 Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, reported financial and corporate results for the fourth quarter ended December 31, 2020 (Press release, Aridis Pharmaceuticals, MAR 30, 2021, View Source [SID1234577389]).

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Fourth Quarter Highlights and Recent Developments

Announced positive preclinical efficacy data for AR-711, a potential inhaled, self-administered, at-home monoclonal antibody treatment ("mAb") for non-hospitalized mild-to-moderate COVID-19 patients. A clinical Phase 1/2 study is expected to be launched in 2H 2021.
Received concurrence from the U.S. Food and Drug Administration ("FDA") to streamline AR-501’s Phase 2 clinical trial design and to expand the originally planned Phase 2a protocol design into a Phase 2a/2b study for treating chronic lung infections in patients with cystic fibrosis (CF). Enrollment completion is expected in late 2021.
Continued enrolling global Phase 3 clinical trial of AR-301 in patients with ventilator associated pneumonia (VAP) including patients who presented with S. aureus VAP as a secondary infection to COVID-19. Interim futility analysis is expected in 2H 2021 and top-line data expected in 1H 2022.
Entered into a ʎPEX out-licensing and product discovery agreement with Kermode Biotechnologies, Inc. on vaccines and mAbs for zoonotic viruses, which are animal viruses that have the ability to infect humans.
Licensed the CRISPR gene editing technology from the Broad Institute of MIT and Harvard. CRISPR is a key component of the APEX mAb discovery and production platform technology.
Executed a Registered Direct offering with gross proceeds of approximately $8.5 million in the fourth quarter and approximately $7.0 million in March 2021.
"During the fourth quarter and over the recent months, we achieved multiple important milestones that impact our clinical and corporate profile, highlighted by the addition of an inhaled at-home COVID-19 treatment (AR-712) to our portfolio of product candidates and entering into an ʎPEX out-licensing and product discovery agreement with Kermode Biotechnologies for zoonotic viruses," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "Additionally, we reached concurrence with the FDA to streamline and thus expedite the clinical and regulatory process for AR-501’s Phase 2 program in cystic fibrosis, and bolstered our balance sheet with the $15.5 million financing. These important achievements have helped position us for continued growth as we head into 2021."

COVID-19 Program Update

AR-712: During the quarter, Aridis announced the development of a highly potent fully human mAb against SARS-CoV-2 virus. AR-712 is a cocktail of two mAbs, AR-711 and AR-713, designed to lower the barrier to treatment coverage of non-hospitalized COVID-19 patients by using a convenient, self-administered inhaled dosage presentation. The two mAbs that comprise AR-712 were discovered from convalescent COVID-19 patients and target the receptor-binding domain (RBD) region of the spike protein of the original SARS-CoV2 virus and its newly emerging variants including the currently prevalent strain ‘E484K’ associated with the South Africa, Brazil, and Japan variants.

In an animal challenge study with golden Syrian hamsters, inhaled AR-711 successfully eliminated all detectable SARS-CoV-2 virus at substantially lower doses than parenterally administered (injected) COVID-19 mAb. The AR-712 mAbs are engineered to be long-acting in blood for up to six to twelve months and are stabilized using a proprietary formulation designed to protect the mAbs from the physical stresses imparted by commercial nebulizer delivery devices on protein drugs. The potency of AR-712 and its direct delivery to the lungs by inhaled administration may facilitate significant dose sparing not achievable by parenteral administration. A proprietary formulation enables AR-712 to be deliverable using a variety of commercially available nebulizers that can be self-administered on an outpatient basis, thus lowering the barrier to COVID-19 therapeutic treatment. Clinical trials for AR-712 are expected to commence 2H 2021.

AR-701: During the quarter, Aridis continued to characterize this cocktail of fully human mAbs discovered from its in-house ʎPEX mAb discovery platform that is directed at multiple envelope proteins of the SARS-CoV-2 virus. AR-701 is intended to treat hospitalized, moderate to severe patients, which complements AR-712’s focus on milder non-hospitalized patients.

Clinical Program Update

AR-301: AR-301 is being evaluated in Phase 3 clinical study as an adjunctive treatment to standard of care antibiotics in S. aureus infected ventilator associated pneumonia (VAP) patients. Thus far, the pace of the trial has continued to be impacted by the protracted COVID-19 pandemic. The Phase 3 interim futility analysis from the ongoing pivotal trial is now expected to be reported in 2H 2021 and top line data by 1H 2022. It’s important to note that COVID-19 patients on prolonged mechanical ventilation in the intensive care unit (ICU) are prone to secondary infections (also called ‘superinfections’) by opportunistic pathogens such as bacteria. Superinfection is a reported complication in COVID-19 patients, which exacerbates morbidity and the rate of mortality. The AR-301 Phase 3 study allows for the enrollment of patients with baseline characteristics which are inclusive of certain COVID-19 patients. While AR-301 is not an agent to treat SARS-CoV-2 virus itself, it can potentially reduce the morbidity associated with secondary S. aureus pneumonia, which is a coronavirus complication and a contributing cause of death in such patients.

The trial, which was initiated in the first quarter of 2019, is expected to enroll 240 patients at approximately 160 clinical centers in 22 countries. Participating clinical centers that are activated continue to follow standard stringent clinical protocols and procedures for critically ill VAP patients, as is standard in the U.S. and Europe. The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute pneumonia in the intensive care unit setting. Details of the study can be viewed on www.clinicaltrials.gov using identifier NCT03816956.

AR-501: During the quarter, the Company announced an agreement with the FDA to simplify AR-501’s Phase 2 trial design for the treatment of chronic lung infections associated with cystic fibrosis (CF). After reporting (June 2020) positive Phase 1 safety data in healthy adults who were exposed to a single ascending dose (SAD) or a multiple ascending dose (MAD) regimen, Aridis proposed, and the FDA has now agreed, to streamline AR-501’s forthcoming Phase 2a clinical trial in CF patients by removing the SAD and only conducting a MAD regimen. The FDA also concurred with the Company’s proposal to expand the originally planned Phase 2a protocol design into a Phase 2a/2b study. This Phase 2a/2b design will enable seamless and efficient advancement of the study from Phase 2a into Phase 2b using the same clinical study protocol. The data from the Phase 2a will inform the dose selection and sample size expansion to achieve statistical significance in efficacy in Phase 2b.

AR-501 is being developed in collaboration with the CF Foundation and has been granted Orphan Drug Designation (ODD), Fast Track and Qualified Infectious Disease Product (QIDP) designations by the FDA. In addition, the European Medicines Agency (EMA) granted ODD to AR-501. The original Phase 1/2a clinical trial was a randomized, double-blinded, placebo-controlled SAD and MAD trial investigating the safety and PK of inhaled AR-501 in healthy volunteers and cystic fibrosis patients with chronic bacterial lung infections. Details of the original Phase 1/2a clinical trial can be viewed on www.clinicaltrials.gov using identifier NCT03669614. The new Phase 2a/b study design will be available on clinicaltrials.gov within the next quarter.

Corporate Update

A key development was the closing of an $8.5 million financing which occurred on October 14th. The proceeds from this registered direct offering and concurrent private placement, strengthens the Company’s balance sheet during the fourth quarter to prioritize the continued advancement of AR-301’s Phase 3 VAP clinical trial, while allocating the requisite resources to AR-501’s Phase 2b cystic fibrosis clinical trial, and the ongoing development of novel COVID-19 therapies such as AR-701 and AR-711.

Fiscal 2020 Fourth Quarter Results:

Cash: Total cash and cash equivalents as of December 31, 2020 was $8.2 million. The Company completed a registered direct financing in March 2021 and received gross proceeds of approximately $7.0 million.
Revenues: Revenue was approximately $1 million for both periods ended December 31, 2020 and 2019. There was no revenue for both quarters ended December 31, 2020 and 2019.
Research and Development Expenses: Research and development expenses decreased by approximately $7.1 million from $24.1 million for the year ended December 31, 2019 to $17.0 million for the year ended December 31, 2020. The year over year decrease was primarily due to the following: a decrease in spending on clinical trial activities and drug manufacturing expenses for the Phase 2 study of our AR-105 program that was terminated during 2019; a decrease in drug manufacturing expenses for the Phase 3 study of our AR-301 program; a decrease in spending on clinical trial activities for the Phase 1/2a study of our AR-501 program because the Phase 1 portion of the study ended in the second quarter of 2020; a decrease in spending on other research and development activities; and a decrease in personnel, consulting and other related costs. These decreases were partially offset by an increase in spending on research and development activities for our COVID-19 program.
There was no material difference in research and development expenses for the quarter ended December 31, 2020 when compared to the same period in 2019.
General and Administrative Expenses: General and administrative expenses increased by approximately $419,000 from $6.0 million for the year ended December 31, 2019 to $6.4 million for the year ended December 31, 2020 due primarily to increases in directors’ and officers’ related liabilities insurance expense, professional service fees, and rent expense due to the Company entering into a new facility lease during the fourth quarter of 2020. These increases were partially offset by a decrease in patent related fees and Delaware franchise taxes. General and administrative expenses incurred in the quarter ended December 31, 2020 were approximately $1.6 million, an increase of approximately $204,000 over the same period in 2019 which was due primarily to increases in professional service fees, personnel related expenses, including stock-based compensation, and rent expense due to the Company entering into a new facility lease during the fourth quarter of 2020, partially offset by a decrease in Delaware franchise taxes.
Interest Income, net: Interest income, net decreased by approximately $280,000 from $357,000 for the year ended December 31, 2019 to $77,000 for the year ended December 31, 2020. Interest income, net for the quarter ended December 31, 2020 decreased by approximately $82,000 over the same period in 2019. These decreases are primarily due to lower interest rates and a lower average cash balance during 2020 as compared to 2019.
Share of Loss from Equity Method Investment: Loss from equity method investment decreased by approximately $942,000 from approximately $951,000 for the year ended December 31, 2019 to $9,000 for the year ended December 31, 2020 as our share of loss from our minority interest in the JV Agreement with Shenzhen Hepalink Pharmaceutical Group Co., Ltd., calculated under the equity method was limited to the reduction of the net book value of the investment to zero as of March 31, 2020. Loss from equity method investment decreased by $41,000 for the quarter ended December 31, 2020 when compared to the same period in 2019 which was due to there being no share of losses from our equity method investment recorded in the fourth quarter of 2020 as the net book value of the investment has been zero since March 31, 2020.
Net Loss: The net loss for the year ended December 31, 2020 was $22.3 million, or $2.44 net loss per share, compared to a net loss of $29.7 million, or $3.51 net loss per share per share, for the year ended December 31, 2019. The net loss for the quarter ended December 31, 2020 was $5.8 million, or $0.59 net loss per share, compared to a net loss of approximately $5.6 million, or $0.63 net loss per share, for the quarter ended December 31, 2019. The weighted average common shares outstanding was approximately 9.2 million and approximately 8.5 million for the year ended 2020 and 2019, respectively.

On March 30, 2021 Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported the publication of a peer-reviewed paper entitled, "Development of a CD8 co-receptor independent T cell receptor specific for tumor-associated antigen MAGE-A4 for next generation T-cell-based immunotherapy" covering preclinical research on a T cell receptor (TCR) specific for a peptide derived from the MAGE-A4 protein in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, MediGene, MAR 30, 2021, View Source [SID1234577444]). The research was conducted by Medigene’s scientists in collaboration with scientists from bluebird bio, Inc. (bluebird bio, NASDAQ: BLUE). The paper was published online: View Source

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The paper describes the discovery and characterization of a MAGE-A4-specific TCR and provides detailed scientific information highlighting the robust potency and exquisite specificity of this TCR against a MAGE-A4-derived peptide.

This MAGE-A4-specific TCR is the most advanced program in Medigene’s collaboration with bluebird bio. This TCR differs from other MAGE-A4 TCRs currently in development elsewhere as it works independently of the T cell co-receptor CD8, which is found on killer T cells. As shown in the paper, this enables T cells equipped with this MAGE-A4 TCR to detect and kill tumor cells expressing MAGE-A4 in a preclinical setting, including helper T cells which express CD4 and not CD8.

Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer of Medigene: "We are delighted to see the high quality of our collaborative research with bluebird bio recognized by this scientific publication. This MAGE-A4-specific TCR, being CD8 co-receptor independent, can activate MAGE-A4-specific responses in either CD4 helper or CD8 killer T cells. In this way, the TCR enables the broadest functional T cell response against MAGE-A4-positive tumor cells and, as demonstrated in preclinical in vivo models, strong control of tumor growth.
Our allogeneic T cell priming, and selection technology was used very successfully to isolate this TCR. This technology is well suited to finding such non-mutated, high avidity TCRs specific for different antigens which we believe will be key to developing next generation TCR-T cells for solid cancer."

Scientific Information
The MAGE-A4-specific HLA-A2-restricted TCR was isolated using Medigene’s allogeneic priming technology to stimulate and screen T cells from an HLA-A2-negative donor for cells with the desired specificity. In preclinical research, the TCR has a favorable activity profile and superior in vivo potency compared to other specific MAGE-A4 TCRs tested (including those isolated from HLA-A2-positive donors who have tolerized T cell repertoires to self-antigens presented by HLA-A2). This non-mutated, high avidity MAGE-A4-specific TCR is CD8 co-receptor-independent, allowing effector functions to be elicited in CD4 helper T cells transduced to express the TCR. These CD4 TCR-T cells not only supported an anti-tumor response by direct killing of MAGE-A4-positive tumor cells, but also upregulated certain properties associated with helper function, such as surface marker expression and release of key cytokines.

On March 30, 2021 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the fiscal year ended December 31, 2020 and provided an update on the Company’s recent and anticipated future developments (Press release, Pieris Pharmaceuticals, MAR 30, 2021, View Source [SID1234577332]).

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"We are pleased to announce the achievement of our second clinical milestone for PRS-060/AZD1402, triggered by the initiation of phase 2a by our partner, AstraZeneca, who further demonstrated their commitment to our respiratory-focused alliance with an equity investment," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "Within our immuno-oncology franchise, we look forward to presenting additional data for two of our 4-1BB-based bispecific programs at AACR (Free AACR Whitepaper), cinrebafusp alfa (PRS-343) and PRS-344, reinforcing our commitment to and leadership in the 4-1BB space. Following the generation of synergistic in vitro data for the combination of cinrebafusp alfa with TUKYSA (tucatinib), we plan to pursue this combination in lower HER2-expressing gastric cancer patients with Seagen. Seagen has also recently made an equity investment in Pieris, further strengthening the alliance we signed in 2018. Partnerships are an important part of our corporate strategy, and our recent announcements reinforce the value our current alliances continue to bring."

PRS-060 & AstraZeneca Collaboration: Pieris will receive a $13 million milestone payment from AstraZeneca for the initiation of patient enrollment in the phase 2a study of PRS-060/AZD1402, an inhaled IL-4 receptor alpha inhibitor the companies are developing for the treatment of moderate-to-severe asthma. The global phase 2a study of PRS-060/AZD1402 is a two-part, multi-center, placebo-controlled clinical study that will evaluate the drug candidate at up to three dose levels using a dry powder formulation administered twice daily on top of standard of care. Additionally, the companies amended their existing agreement to restructure certain commercial economics for PRS-060/AZD1402 by adjusting various milestones and royalty provisions, while fundamentally maintaining the overall value split between AstraZeneca and Pieris. In connection with the amendment, AstraZeneca will make a $10 million equity investment in Pieris through the purchase of 3,584,230 newly-issued shares of Pieris common stock at a price of $2.79 per share.
Cinrebafusp Alfa (PRS-343): Pieris will present an updated dataset for cinrebafusp alfa (PRS-343), a 4-1BB/HER2 bispecific for the treatment of HER2-expressing solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (AACR) (Free AACR Whitepaper) on April 10, 2021. The presentation will include additional clinical benefit and safety data from cohort 13b (18 mg/kg, administered Q2W), as well as biomarker data across all active dose cohorts. The Company is preparing for the phase 2 study of cinrebafusp alfa, expected to begin in the summer of 2021. The phase 2 study will evaluate cinrebafusp alfa in combination with ramucirumab and paclitaxel in high HER2-expressing gastric cancer and in combination with tucatinib in low HER2-expressing gastric cancer. Collaboration partners Lilly and Seagen will supply ramucirumab and tucatinib, respectively, for these study arms.
Seagen Collaboration Expansion: Seagen made a $13 million equity investment in Pieris as part of an ongoing collaboration between the companies. Additionally, the companies have entered into a clinical trial and supply agreement to evaluate the safety and efficacy of combining Pieris’ cinrebafusp alfa with Seagen’s TUKYSA (tucatinib), a small-molecule tyrosine kinase HER2 inhibitor, for the treatment of gastric cancer patients expressing lower HER2 levels (IHC2+/ISH- & IHC1+) as part of the upcoming phase 2 study to be conducted by Pieris. The companies have also amended their existing immuno-oncology collaboration whereby Pieris’ option to co-develop and co-commercialize the second of three programs in the collaboration has been converted to a co-promotion option in the United States.
PRS-344 & Servier Collaboration: Pieris and Servier will present preclinical data for PRS-344/S095012, a 4-1BB/PD-L1 bispecific, as part of a poster session at the AACR (Free AACR Whitepaper) Annual Meeting 2021. The presentation will showcase synergistic data, including in vitro data evaluating potential effects of combining 4-1BB with PD-L1 and the effects of PRS-344 on CD8+ T cells, as well as dose-dependent anti-tumor response in in vivo preclinical models. PRS-344 is expected to enter phase 1 studies this year. Pieris holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales by Servier for this program. Additionally, Pieris completed non-GLP preclinical work for PRS-352, a preclinical-stage program addressing undisclosed targets for immuno-oncology, last quarter; Servier is fully responsible for further development of that program.
Preclinical Respiratory Pipeline: Pieris and AstraZeneca continue to advance each of the four programs in the collaboration beyond PRS-060/AZD1402. Pieris also continues to advance several proprietary discovery-stage respiratory programs and expects to share data and rationale for advancement of one of its proprietary programs this year.
AACR Details:

Cinrebafusp Alfa Oral Presentation:

Title: Clinical and biomarker activity of PRS-343, a bispecific fusion protein targeting 4-1BB and HER2, from a Phase 1 study in patients with advanced solid tumors
Abstract: CT017
Session: CTMS01 – Early Clinical Trials with New Anticancer Agents
Date/Time: The presentation will take place at 2:05 PM EDT on Saturday, April 10, 2021 on Channel 08.

PRS-344 Poster:

Title: Simultaneous costimulatory T-cell engagement and checkpoint inhibition by PRS-344/S095012, a PD-L1 / 4-1BB bispecific compound for tumor localized activation of the immune system
Abstract: LB135
Session: PO.ET01.08 – Targeting the Tumor Microenvironment in Drug Development
Date/Time: This poster will be available beginning at 8:30AM EDT on Saturday, April 10, 2021.

Fiscal Year Financial Update:

Cash Position – Cash and cash equivalents totaled $70.4 million for the year ended December 31, 2020, compared to a cash, cash equivalents, and investments balance of $104.2 million for the year ended December 31, 2019. The decrease was primarily due to funding operating and capital expenses in 2020, partially offset by ATM proceeds and milestone achievements during the year. The December 31, 2020 ending cash position excludes the $13 million received from Seagen in March 2021 and the $23 million to be received from AstraZeneca in connection with the phase 2a study initiation and equity investment.

R&D Expense – R&D expenses were $46.5 million for the year ended December 31, 2020, compared to $55.0 million for the year ended December 31, 2019. The decrease in R&D expenses was primarily due to lower clinical and manufacturing costs on our immuno-oncology programs, in part due to the partial clinical hold on cinrebafusp alfa, lower manufacturing spending on PRS-060 (which is fully reimbursed by AstraZeneca), and lower travel-related expenditures due to COVID-19 restrictions. The overall decrease was partially offset by an increase in allocated IT and facility costs due to the move to a new R&D facility in Hallbergmoos, Germany in early 2020.

G&A Expense – G&A expenses were $16.7 million for the year ended December 31, 2020, compared to $18.4 million for the year ended December 31, 2019. The decrease in G&A expenses was primarily due to lower personnel costs, lower audit and professional fees related to Sarbanes-Oxley readiness, and lower travel-related expenditures due to COVID-19 restrictions. These decreases were partially offset by higher allocated IT and facility costs due to the move to the new R&D facility.

Net Loss – Net loss attributable to common stockholders was $37.2 million or $(0.68) per share for the year ended December 31, 2020, compared to a net loss of $28.3 million or $(0.56) per share for the year ended December 31, 2019.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Tuesday, March 30, 2021, to discuss the full-year financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On March 30, 2021 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported financial results for the fourth quarter and full year 2020 and provided an operational update (Press release, Bellicum Pharmaceuticals, MAR 30, 2021, View Source [SID1234577358]).

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"In 2020, we refined our focus on our next generation CAR-T cell therapies," said Rick Fair, President and Chief Executive Officer. "We are excited to have resumed our trial of BPX-601 with a focus on prostate cancer and initiated the BPX-603 trial in HER2+ solid tumors, and we look forward to providing updates on both programs as the year progresses."

Program Highlights and Current Updates

BPX-601 GoCAR-T
•In January, Bellicum announced the U.S. Food and Drug Administration (FDA) had lifted the clinical hold on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer. Bellicum has worked with clinical investigators to resume screening for patient enrollment without modification to the current study protocol.

•Bellicum plans to present a Phase 1 data update on BPX-601 and rimiducid in patients with metastatic castration-resistant prostate cancer in the first quarter of 2022.

BPX-603 GoCAR-T
•In December, Bellicum announced the enrollment and apheresis of the first patient in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is the company’s first dual-switch GoCAR-T product candidate, which incorporates Bellicum’s iMC activation and CaspaCIDe safety switch technologies. The company expects to provide initial Phase 1 data from this trial in the second half of 2021.

CaspaCIDe
•In February, Bellicum announced the first reported use of the CaspaCIDe safety switch to mitigate CAR-T cell toxicity. The report, published as an ahead-of-print publication in the digital edition of Blood, a journal published by The American Society of Hematology (ASH) (Free ASH Whitepaper), was a case from an investigator-sponsored trial (IST) at the University of North Carolina Lineberger Comprehensive Cancer Center of autologous CAR-T cells expressing CD19 and CaspaCIDe. In this patient, grade 3-4 immune effector cell-associated neurotoxicity syndrome (ICANS) refractory to standard therapies was treated with rimiducid to activate CaspaCIDe. Within twelve hours of rimiducid administration, ICANS grade improved from 3 to 1 and was fully resolved after four days.

1

Exhibit 99.1

Corporate Updates

•In November, Bellicum completed an underwritten offering of 1,040,000 shares of common stock, pre-funded warrants to purchase 3,109,378 shares of common stock and accompanying warrants to purchase 4,149,378 shares of common stock. Gross proceeds to Bellicum were approximately $25.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Bellicum and excluding any proceeds that may be received upon exercise of the warrants.

•In October, Bellicum implemented a restructuring program to focus on the clinical development of BPX-601 and BPX-603, reduce headcount, pause the BCMA GoCAR-NK program, and discontinue discovery research and new product development.

•In October, Bellicum repaid in full all outstanding indebtedness and terminated all commitments and obligations under its loan agreement with Oxford Finance, for a payment of $27.4 million.

Fourth Quarter 2020 Financial Results

R&D Expenses: Research and development expenses were $8.7 million and $39.1 million for the fourth quarter and year ended December 31, 2020, respectively, compared to $13.3 million and $64.5 million during the comparable periods in 2019. The reduction in expenses in the fourth quarter resulted primarily from reduced expenses related to reduced rivo-cel related activities, reduced expenses resulting from Bellicum’s sale of its manufacturing facility and the corporate restructuring implemented during the fourth quarter of 2020, partially offset by an increase in expenses related to the GoCAR programs.

G&A Expenses: General and administrative expenses were $3.4 million and $15.5 million for the fourth quarter and year ended December 31, 2020, respectively, compared to $5.7 million and $30.0 million during the comparable periods in 2019. The reduction in expenses during the fourth quarter relative to the comparable period in 2019 was primarily due to the reduction in rivo-cel related commercialization activities as well as the effects of the corporate restructuring that reduced employee-related charges.

Loss from Operations: Bellicum reported a loss from operations of $13.0 million and $51.7 million for the fourth quarter and year ended December 31, 2020, respectively, compared to a loss from operations of $13.9 million and $87.4 million for the comparable periods in 2019.

Net Income/Loss: Bellicum reported net income of $18.8 million and a net loss $7.7 million for the fourth quarter and year ended December 31, 2020, respectively, compared to a net loss of $29.0 million and $112.5 million for the comparable periods in 2019. The results included a non-cash gain of $31.9 million and $46.1 million related to the change in fair value of the warrant and private placement option liability for the fourth quarter and year ended December 31, 2020, respectively.

Shares Outstanding: As of March 22, 2021, Bellicum had 8,318,273 shares of common stock and 452,000 shares of preferred stock outstanding. Each share of preferred stock can be converted into 10 shares of common stock. In the November 2020 financing, the company issued 1,040,000 shares of common stock and pre-funded warrants to purchase 3,109,378 shares of common stock.

Cash Position and Guidance: Bellicum reported cash and cash equivalents and restricted cash totaling $37.0 million as of December 31, 2020, compared to $93.8 million as of December 31, 2019. Based on current operating plans, Bellicum expects that current cash resources will be sufficient to meet operating requirements into the second quarter of 2022.

Conference Call and Webcast
Bellicum’s management will host a webcast and conference call today at 5 p.m. ET / 2 p.m. PT, March 30, 2021, to discuss the financial results for the fourth quarter 2020 and provide a corporate update. The live call may be accessed by dialing (877) 407-3103 for domestic callers and (201) 493-6791 for international
2

Exhibit 99.1

callers. A live webcast of the call will be available from the Investors and Media section of the company’s website at www.bellicum.com and a replay will be available shortly after the live event.

On March 30, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the third quarter of fiscal year 2021, which ended February 28, 2021 (Press release, AngioDynamics, MAR 30, 2021, View Source [SID1234577374]).

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"I am pleased with our strong third quarter performance, driven by continued strength in our AngioVac and Auryon platforms. Our revenue grew 2% year over year despite continued COVID-19 headwinds, particularly in January and the first half of February. Further, we are encouraged by the recent improvements in our end markets and increasing availability of vaccines," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We continue to execute on our strategy to drive revenue growth through our key technology platforms: Auryon, AngioVac, and NanoKnife. In addition, our balanced approach to cash and expense management continues to yield profitability on an adjusted basis while allowing us to invest in the development and progression of these key platforms. I am excited about the planned launch of our new mechanical thrombectomy device later in calendar 2021, as well as a number of other planned product improvements and clinical and regulatory pathway expansions that will open up opportunities for us in larger, higher-growth markets."

Third Quarter 2021 Financial Results

Net sales for the third quarter of fiscal 2021 were $71.2 million, an increase of 2.0% compared to the prior-year quarter. Net sales in the third quarter continued to be impacted by the disruption to procedure volumes resulting from the COVID-19 global pandemic. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Vascular Interventions and Therapies ("VIT") net sales were $33.3 million, an increase of 8.8%, compared to $30.6 million a year ago. Growth was driven primarily by increased sales of the Company’s Auryon and AngioVac platforms compared to the previous year. This growth was partially offset by a decline in sales of Venous products resulting from a decline in elective procedure volumes due to the ongoing COVID-19 global pandemic. Auryon sales during the quarter were $3.3 million.
Oncology net sales were $13.1 million, a decrease of 10.1% from $14.6 million in the prior-year period. The year-over-year decline was primarily attributable to lower capital sales and ongoing procedure impacts of COVID-19, particularly in international markets, partially offset by continued growth in sales of NanoKnife disposables in the United States.
Vascular Access net sales were $24.8 million, compared to $24.6 million a year ago.
U.S. net sales in the third quarter of fiscal 2021 were $58.7 million, an increase of 6.9% from $54.9 million a year ago. International net sales were $12.5 million in the third quarter of fiscal 2021 compared to $14.9 million a year ago.

Gross margin for the third quarter of fiscal 2021 was 54.1%, a decline of 370 basis points compared to the third quarter of fiscal 2020. Consistent with the first half of the year, the year-over-year decline in gross margin was primarily due to Auryon start-up costs and the Company’s previously discussed COVID-related operating plan, including under-absorption of the Company’s manufacturing facilities attributable to additional operating protocols designed to secure the supply-chain and prioritize employee safety. In addition, gross margin was negatively impacted by staffing challenges in the Company’s upstate New York manufacturing facility. During the third quarter, inventory was reduced by $0.6 million when compared to inventory levels on November 30, 2020. During the fiscal year, inventory levels have been reduced by $10.9 million.

The Company recorded a net loss of $3.5 million, or loss per share of $0.09, in the third quarter of fiscal 2021. This compares to a net loss of $5.7 million, or loss per share of $0.15, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the third quarter of fiscal 2021 was $0.7 million, and adjusted earnings per share was $0.02, compared to adjusted net income in the prior-year period of $0.4 million and adjusted earnings per share of $0.01. Adjusted net income and adjusted earnings per share in the third quarter of fiscal 2021 includes a $1.9 million, and $0.04 per share benefit, respectively, related to the reimbursement of certain expenses under the CARES Act.

Adjusted EBITDA in the third quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $5.4 million, compared to $3.8 million in the third quarter of fiscal 2020.

In the third quarter of fiscal 2021, the Company generated $5.9 million in operating cash and had capital expenditures of $1.4 million. As of February 28, 2021, the Company had $54.5 million in cash and cash equivalents compared to $58.0 million in cash and cash equivalents on November 30, 2020. The Company reduced its debt outstanding under its revolving credit facility at February 28, 2021, to $30.0 million compared to $40.0 million at November 30, 2020. Subsequent to the end of the third fiscal quarter, the Company further reduced debt outstanding under the revolving credit facility to $20 million. Management remains focused on cash preservation and expense management amid the current environment.

Nine Months Financial Results

For the nine months ended February 28, 2021:

Net sales were $214.2 million, an increase of 4.1%, compared to $205.8 million for the same period a year ago.
The Company’s net loss was $12.1 million, or a loss of $0.32 per share, compared to a net loss of $9.7 million, or a loss of $0.26 per share, a year ago.
Gross margin decreased 490 basis points to 53.4% from 58.3% a year ago due to the Company’s COVID-related operating plan and Auryon start-up costs.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.9 million, with adjusted earnings per share of $0.05, compared to adjusted net income and adjusted earnings per share of $5.7 million, and $0.15, respectively, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $15.0 million, compared to $17.5 million for the same period a year ago.
Fiscal Year 2021 Financial Guidance

The Company is increasing its guidance for fiscal year 2021. Management now projects net sales between $285 and $288 million and fiscal year 2021 adjusted earnings per share between $0.04 and $0.06, compared to previous projections of net sales between $278 and $284 million and adjusted earnings per share between $0.00 and $0.05.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2021 third quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13717367.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, March 30, 2021, until 11:59 p.m. ET on Tuesday, April 6, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13717367.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.