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.

On March 30, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Asher Biotherapeutics for systems pharmacology modeling in solid tumors (Press release, Applied BioMath, MAR 30, 2021, View Source [SID1234577390]). "We have experience that development of a biotherapeutic has the best chance of success when the R&D process is supported by mathematical modeling," said Lioudmila Tchistiakova, Entrepreneur in Residence at Third Rock Ventures. "We have chosen to collaborate with Applied BioMath given their proven track record in this space," said Ivana Djuretic, PhD, Chief Scientific Officer of Asher Biotherapeutics. "This collaboration will enable us to confidently predict pharmacokinetics, receptor occupancy, and pharmacodynamics of our lead molecule."

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Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Systems pharmacology modeling’s impact is extremely effective when leveraged early on in the R&D process," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "Incorporating modeling early on helps the project team gain thorough understanding of their lead molecule which in turn helps increase the likelihood of success in the clinic."

On March 30, 2021 Immunovia reported improved performance of its blood based IMMray PanCan-d biomarker signature together with CA 19-9, in a clinical retrospective study (Press release, Immunovia, MAR 30, 2021, View Source [SID1234577294]). The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia’s test now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%. The improved test performance was demonstrated in a combined samples cohort of newly collected samples and samples from the Clinical Verification study. In total 433 samples of which 202 were PDACs whereof 89 PDAC stage I/II and 231 symptomatic controls were analyzed. These samples have been freshly collected from 7 sites in the US and Europe: Beth Israel Deaconess Medical Center, University of Pittsburgh Medical Center, Pancreatic Cancer Center at NYU Langone’s Perlmutter Cancer Center in the US; University College London in the UK; Sahlgrenska University Hospital in Sweden; and University Hospital Erlangen in Germany; and Ramón y Cajal University Hospital, IRYCIS, CIBERONC in Spain.

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Linda Mellby, PhD, VP R&D Immunovia commented: "Detecting pancreatic cancer as early as possible in high risk symptomatic patients is a challenging but extremely important achievement that will support clinicians in providing accelerated and correct diagnosis to the patients. We are very excited to report 92% specificity and 80 % sensitivity for detecting early stage pancreatic cancer in this risk group of patients."

Patrik Dahlen, CEO, Immunovia added: " These results demonstrate great performance for detection of early stage pancreatic cancer in symptomatic cohorts, and they further confirm the commercialization strategy for this important risk group of patients. The market size for the symptomatic risk group is 1-2 million patients in USA and Europe. Our test is designed to help clinicians find the cancer at a treatable stage and thus help the patients live longer."

Webcasted teleconference

These results will be presented Tuesday March 30, 2021, in a webcasted teleconference at 16.30 (CET).

Presenters: Thomas King, MD, PhD, Linda Mellby, PhD, Patrik Dahlen CEO, Immunovia

The presentations will be followed by a Q&A session. The webcasted teleconference will be held in English.

On March 30, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the fiscal year ended December 31, 2020 and provided a business update on recent corporate and clinical developments (Press release, Protalix, MAR 30, 2021, View Source [SID1234577333]).

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"2020 was an important year for Protalix, as we continued to strengthen the clinical profile of PRX–102 for the treatment of Fabry disease and advance towards potential commercialization of our lead pipeline program," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We advanced our earlier stage pipeline with the exclusive partnership we announced with SarcoMed USA for our PRX–110 asset, and we solidified our balance sheet to provide the financial backing to drive the Company through our 2021 milestones."

"We expect 2021 will also be an important year for Protalix as we await the FDA’s review of the PRX–102 BLA on the upcoming April 27, 2021 PDUFA date. We are grateful to our employees and external partners for their commitment and dedication during a very challenging time with the global pandemic. We look forward to continuing to build stockholder value," concluded Mr. Bashan.

2020 Full-Year and Recent Business Highlights

Regulatory Advancements

On August 11, 2020, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, announced that the FDA had accepted the BLA for PRX–102, and granted Priority Review designation for PRX–102, for the proposed treatment of adult patients with Fabry disease. The FDA indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application. The FDA set a PDUFA action date of January 27, 2021. However, as previously announced in November 2020, the FDA subsequently extended the PDUFA action date to April 27, 2021. As we disclosed last year, the FDA has advised that it will have to inspect our manufacturing facility and the facility of a third party in Europe that performs fill and finish processes for PRX-102 as part of its review of the BLA to ensure cGMP compliance. Due to COVID-19-related FDA travel restrictions, the FDA has advised that it may be unable to conduct the inspections prior to the PDUFA action date. The Company, together with Chiesi, is addressing this issue.
Clinical Advancements

On February 23, 2021, the Company, together Chiesi, announced positive topline results from the phase III BRIGHT clinical trial, a study designed to evaluate the safety, efficacy and pharmacokinetics of pegunigalsidase alfa, or PRX–102, treatment, 2 mg/kg every four weeks, in up to 30 patients with Fabry disease previously treated with a commercially available enzyme replacement therapy (ERT) (agalsidase alfa – Replagal or agalsidase beta – Fabrazyme). Topline results indicate that 2 mg/kg of PRX-102 administered by intravenous infusion every four weeks was found to be well tolerated among treated patients, and stable clinical presentation was maintained in adult Fabry patients.
On December 30, 2020, the Company, together with Chiesi, announced final study results from the phase III BRIDGE clinical trial, a 12–month open-label, single arm switch-over study evaluating the safety and efficacy of PRX–102, 1 mg/kg infused every two weeks, in up to 22 Fabry patients. Final results of the data generated in the study showed substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in both male and female patients who were switched from agalsidase alfa to PRX-102.
On October 2, 2020, the Company, together with Chiesi, announced the launch of an Expanded Access Program (EAP) in the United States for PRX–102 for the proposed treatment of Fabry disease.
Corporate & Financial Developments

On February 17, 2021, the Company successfully completed a public offering of its common stock raising gross proceeds of approximately $40.2 million at a price equal to $4.60 per share, before deducting the underwriting discount and estimated expenses of the offering, which was led by BofA Securities and Oppenheimer & Co.
On February 10, 2021, the Company entered into an exclusive partnership with SarcoMed USA for the worldwide development and commercialization of alidornase alfa, or PRX-110, for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis and other related diseases via inhaled delivery.
On March 18, 2020, the Company successfully completed a private placement of its common stock to certain existing and new institutional and other accredited investors raising aggregate net proceeds of approximately $41.3 million at a price equal to $2.485 per share. Each share of common stock issued in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.
On March 16, 2020, the Company announced that it had agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx. Kirin is providing research funding for Protalix scientists to conduct cell line engineering and protein expression studies on the target protein.
Financial Results

For the year ended December 31, 2020, compared to the year ended December 31, 2019

The Company recorded revenues from selling goods of $16.2 million for the year ended December 31, 2020 compared to revenues of $15.9 million for the same period of 2019.
Revenue from licenses and R&D services for the year ended December 31, 2020 were $46.7 million compared to $38.8 million for the year ended December 31, 2019. Revenue from license agreements is recognized in conjunction with the license and supply agreements with Chiesi. The increase is primarily due to revenues recognized in connection with an updated cost estimation of two completed phase III clinical trials of PRX-102.
Cost of goods sold was $10.9 million for the years ended December 31, 2020, and December 31, 2019.
Research and development expenses net for the year ended December 31, 2020 were $38.2 million compared to $44.6 million for the year ended December 31, 2019. The decrease is primarily due to the completion of two out of the three phase III clinical trials of PRX-102 and reduced costs related to the phase III BALANCE study, as well as a decrease in costs related to manufacturing of the Company’s drug in development as some of the manufactured drug product and related costs have been recorded as inventory. The Company expects research and development expenses to continue to be its primary expense as it enters into a more advanced stage of preclinical and clinical trials for certain of its product candidates.
Selling, general and administrative expenses were $11.1 million for the year ended December 31, 2020, an increase of $1.2 million, or 12%, from $9.9 million for the year ended December 31, 2019. The increase resulted primarily from an increase in share-based compensation costs.
Financial expenses, net was $9.2 million for the year ended December 31, 2020 compared to $7.6 million for the same period of 2019.
Cash, cash equivalents and short-term bank deposits were approximately $38.5 million on December 31, 2020. During the first quarter of 2021, the Company raised gross proceeds of $8.8 million from the sale of common stock under its ATM program and gross proceeds of $40.2 million via the public offering of its common stock.
Net loss for the year ended December 31, 2020 was $6.5 million, or $0.22 per share, basic and diluted, compared to a net loss of $18.3 million, or $1.23 per share, basic and diluted, for the same period in 2019.
Conference Call and Webcast Information

The Company will host a conference call today, March 30, 2021 at 8:30 am Eastern Daylight Time, to review the clinical, corporate, and financial highlights, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source
Webcast Link: View Source
Conference ID: 13716316

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On March 30, 2021 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints reported the closing of a $73 million Series B1 and B2 financing (Press release, Immune-Onc Therapeutics, MAR 30, 2021, View Source [SID1234577375]). The round was led by Oceanpine Capital with participation from additional new investors including Octagon Capital and Sphera Healthcare, and existing investors, including Northern Light Venture Capital and Vivo Capital. In conjunction with this round of financing, Oceanpine CEO and managing partner Dave Chenn joins the Immune-Onc Board of Directors. In addition, the company received a strategic capital investment from The Leukemia & Lymphoma Society’s Therapy Acceleration Program (LLS TAP), directed toward advancing the company’s work to treat blood cancers.

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"We are delighted that this high-caliber group of new and existing investors share our excitement about the transformative potential of myeloid checkpoint inhibition and believe in Immune-Onc’s ability to deliver on this promise with our pipeline of first-in-class cancer immunotherapies," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "This round of investment was substantially over-subscribed, enabling the company to accelerate the clinical development of multiple novel assets, and deliver what we believe is the next breakthrough in immunotherapy treatment for many of the world’s most devastating cancers."

Proceeds from the financing will allow Immune-Onc to advance its portfolio of blood cancer and solid tumor immunotherapies targeting myeloid checkpoints with a focus on the LILRB family. Immune-Onc has raised more than $110 million from investors since the company began operations in 2016. In August 2020, the company announced it had been awarded a Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to support clinical development of IO-202.

"We are enthusiastic about Immune-Onc’s novel approach to cancer immunotherapy targeting myeloid checkpoints and their leading portfolio of first-in-class assets," said Dave Chenn, CEO and managing partner of Oceanpine Capital. "We have full confidence in the company’s highly experienced management team and are excited to be at the forefront of this new area of research and development through our investment in Immune-Onc supporting their next phase of growth."

Immune-Onc’s Pipeline

Immune-Onc’s research and development programs focus on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints to overcome immune resistance of cancer. The company has invested in proprietary models, assays and tools to interrogate the biology and translate this cutting-edge research into the development of novel therapies.

Immune-Onc’s lead program IO-202, a first-in-class antibody targeting LILRB4 (also known as ILT3), is being developed to treat blood cancers, including acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML), and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of hematologic cancer cells.

In September 2020, Immune-Onc initiated a Phase I trial evaluating IO-202 in AML with monocytic differentiation and in CMML. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designation status for treatment of AML in October 2020. The company is also evaluating IO-202 in solid tumors and will present preclinical data for the first time on April 10, 2021 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (#AACR21).

Immune-Onc has active preclinical programs targeting other members of the LILRB family including IO-108, a novel antagonist antibody targeting LILRB2 (also known as ILT4) which is currently in the IND-enabling stage. The company presented preclinical data supporting IO-108 for the treatment of solid tumors at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting and plans to submit an investigational new drug application in mid-2021. Other preclinical assets include IO-106, a first-in-class anti-LAIR1 antibody, and multiple undisclosed programs for solid tumors and hematologic malignancies.

About The Leukemia & Lymphoma Society and Therapy Acceleration Program (TAP)

The Leukemia & Lymphoma Society (LLS) is a global leader in the fight against cancer. The LLS mission is to cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the ability to change the standard of care. LLS TAP funds late-stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance therapeutics along the drug development and approval pathway. To learn more, visit www.LLS.org/therapy-acceleration-program. Follow LLS on Facebook, Twitter, and Instagram.