On May 9, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the first quarter ended March 31, which included an increase in revenue of 128 percent from the prior-year period and a net loss of $19.8 million, or $0.16 per share, compared to a net loss in the first quarter of 2015 of $15.1 million, or $0.12 per share (Press release, Halozyme, MAY 9, 2016, View Source [SID:1234512116]).

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"During the first quarter, we continued to execute against our two-pillar strategy with ongoing clinical studies of PEGPH20 and through growing the value of our ENHANZE platform," said Dr. Helen Torley, president and chief executive officer. "We made good progress toward our goal of initiating greater than 90 percent of HALO-301 sites by the end of the year and in evaluating the recommended dose to take into the expansion phase of our lung and gastric cancer studies.

"With our ENHANZE platform, we continued to see strong growth in royalty revenue combined with progress from our partners’ programs. During the quarter, Lilly nominated its third target triggering an $8 million milestone and Pfizer nominated an additional target triggering a $1.5 million milestone. These developments highlight the great potential associated with our ENHANZE technology franchise."

First Quarter 2016 and Recent Highlights include:

Dosing of first patient in HALO-301 | Pancreatic study in March, a phase 3 study to explore PEGPH20 with gemcitabine and ABRAXANE (nab-paclitaxel) in metastatic pancreatic cancer patients. The company plans to initiate sites outside the United States beginning in the second quarter and to reach its target of greater than 90 percent of centers ready to start screening patients by the end of the year.
Approval by the Food and Drug Administration (FDA) of an investigational device exemption for the companion diagnostic test developed with Ventana to prospectively identify patients with high levels of hyaluronan, or HA, in the company’s phase 3 study.
Progressing towards dose expansion in its phase 1b/2 PRIMAL study of PEGPH20 plus docetaxel in non-small cell lung cancer patients. The company is now evaluating patients at a dose of 2.2 µg/kg and remains on track to move into the dose expansion phase of the study in the second half of 2016.
Advancing into the second dosing cohort and recently submitting a protocol amendment in its phase 1b study of PEGPH20 plus KEYTRUDA (pembrolizumab) in lung and gastric cancer patients. The company submitted the protocol amendment to the FDA based on bleeding events observed in heavily pretreated relapsed gastric cancer patients. These events were not classified as dose limiting toxicities or determined by investigators to be related to PEGPH20. Halozyme is awaiting feedback from the FDA and plans to resume enrollment in the second dosing cohort following approval of the amendment.
Eli Lilly nominating their third target to be studied with Halozyme’s ENHANZE platform, triggering an $8 million milestone payment to Halozyme which will be received in the second quarter.
Pfizer nominating an additional target to be studied with Halozyme’s ENHANZE platform, triggering a $1.5 million milestone to Halozyme.
Baxalta receiving a positive opinion for HYQVIA from the Committee for Medicinal Products for Human Use for a pediatric indication in Europe. In addition, Baxalta initiated a phase 3 trial in patients with chronic inflammatory demyelinating polyneuropathy.
Expansion of oncology pipeline and demonstration of expertise in the tumor microenvironment with two new preclinical programs, an immune checkpoint inhibitor targeting adenosine and a novel antibody-drug conjugate targeting epidermal growth factor receptor. Preclinical data for the discovery and early development of these potential drug candidates were shared during the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual conference.
First Quarter 2016 Financial Highlights

Revenue for the first quarter was $42.5 million, compared to $18.7 million for the first quarter of 2015, driven primarily by milestone payments from Lilly and AbbVie, as well as royalties from partner sales of Herceptin SC, MabThera SC and HYQVIA. Revenue for the quarter included $11.4 million in royalties, $9.0 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $3.9 million in HYLENEX recombinant (hyaluronidase human injection) product sales.
Research and development expenses for the first quarter were $40.1 million, compared to $16.7 million for the first quarter of 2015. The planned increases were primarily due to expenses for preclinical and clinical support of PEGPH20 and clinical API supply to ENHANZE partners.
Selling, general and administrative expenses for the first quarter were $10.8 million, compared to $9.4 million for the first quarter of 2015. The increase was primarily due to an increase in personnel expenses, including stock compensation, for the period.
Net loss for the first quarter was $19.8 million, or $0.16 per share, compared to a net loss in the first quarter of 2015 of $15.1 million, or $0.12 per share.
Cash, cash equivalents and marketable securities were $238.6 million at Mar. 31, 2016 compared to $108.3 million at Dec. 31, 2015.
Financial Outlook for 2016

For the full year 2016, the company is updating its previously announced guidance. Halozyme now expects:

Net revenues to be in the range of $130 million to $145 million, an increase from the prior range of $110 million to $125 million, driven by unplanned ENHANZE milestones and an increase in bulk product sales to ENHANZE partners;
Operating expenses to be in the range of $245 million to $260 million, a narrowing of the bottom end of the prior range of $240 million to $260 million as a result of the increase in product sales to ENHANZE partners;
Cash flow to be in the range of $45 million to $65 million, an increase from the prior range of $35 million to $55 million; and
Year-end cash balance to be in the range of $150 million to $170 million, an increase from the prior range of $140 million to $160 million.

On May 9, 2016 GTx, Inc. (Nasdaq: GTXI) reported the first public presentation of preclinical data from the Company’s selective androgen receptor degrader (SARD) program (Press release, GTx, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166265 [SID:1234512115]). The results demonstrate that the Company’s highly potent SARDs selectively bind to the ligand binding domain (LBD) and interact with the N-terminal domain (NTD) of the androgen receptor (AR) and inhibit and degrade the AR at very low concentrations. These preclinical results suggest that the Company’s SARDs may be the first-in-class dual-interacting AR antagonists and degraders.

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The preclinical data are being presented at the 2016 American Urological Association (AUA) Annual Meeting taking place May 6-10, 2016, in San Diego, California.

Poster: Novel Dual-Binding Selective Degraders of Full Length and Splice Variant Androgen Receptors for the Treatment of Castration-Resistant Prostate Cancer

Presenter: Ramesh Narayanan, Ph.D., Director, Center for Cancer Drug Discovery and Associate Professor, Department of Medicine, University of Tennessee and Consultant for GTx, Inc.

Date:
Saturday, May 7 at 10:30 am until Tuesday, May 10 at 1:00 pm

According to Dr. Narayanan, "One of the limitations of current prostate cancer therapy is that some men with castration-resistant prostate cancer do not respond or eventually develop resistance to the therapy. These preclinical results suggest that novel SARD compounds may degrade and inhibit multiple forms of the androgen receptor, including AR splice variants, and may therefore potentially treat CRPC in men who are non-responsive to androgen therapy."

The Company’s lead SARD compounds are currently being evaluated in preclinical studies in order to select the best SARD compounds for continued development, with a goal of initiating first human clinical trials in 2017.

About SARDs

Selective Androgen Receptor Degrader (SARD) technology is being evaluated as a potentially novel treatment for men with castration-resistant prostate cancer (CRPC), including those who do not respond or are resistant to currently approved therapies. GTx believes that its novel SARD compounds will degrade multiple forms of the androgen receptor, including AR splice variants, such as AR-V7. GTx licensed the SARD technology from the University of Tennessee Research Foundation in 2015 with the goal of expanding its portfolio of product candidates targeting hormonal receptors.

About Prostate Cancer

Prostate cancer that is localized to the prostate can be effectively treated with surgery, radiation, brachytherapy and other modalities in an effort to eradicate all of the disease and cure the patient. In some cases, the tumor advances locally or metastasizes; these are examples of advanced prostate cancer. The goal of treatment for advanced prostate cancer is to control the tumor and keep the patient alive for as long as possible.

In advanced prostate cancer, a number of treatments with hormone blocking therapies or chemotherapy are used to slow the spread of metastases, shrink existing tumors, reduce symptoms and improve quality of life. Although most men with advanced prostate cancer are not cured of their disease, they can live a normal life for many years.

On May 9, 2016 Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, reported recent business and program highlights as part of its multi-year vision and financial results for the first quarter of 2016 (Press release, Epizyme, MAY 9, 2016, View Source [SID:1234512112]).

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"We have made significant progress in our clinical development program for tazemetostat and all four areas of our multi-year vision," said Robert Bazemore, President and Chief Executive Officer of Epizyme. "We are well underway with plans to expand the tazemetostat clinical program into combination studies and its third cancer indication, continuing to advance our discovery pipeline and collaborative research efforts and have strengthened our team and business operations. With a number of milestones on the horizon, we are positioned to continue this momentum."

Accelerate Tazemetostat Program in Non-Hodgkin Lymphoma and Solid Tumors

Epizyme has submitted an abstract to present a study update from its phase 2 program in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting on Lymphoma Biology in June. This presentation will include a progress update on the study enrollment, safety experience for all patients enrolled and an early look at clinical activity in the patient populations that have surpassed their futility hurdle as confirmed by the Independent Data Monitoring Committee (IDMC). The three arms confirmed to have surpassed the futility hurdle are: germinal center diffuse large B-cell lymphoma (DLBCL) with an EZH2 mutation; germinal center DLBCL with wild-type EZH2; and non-germinal center DLBCL. Futility in each of the DLBCL arms is based on observing at least one objective response in the first ten patients enrolled. Responses have been observed in the two arms enrolling patients with follicular lymphoma; however, neither arm has yet reached its futility hurdle, which is at least two objective responses out of the first ten patients enrolled.

The IDMC recently approved Epizyme’s planned expansion of enrollment in all five arms of the phase 2 study in patients with NHL. The total population will increase to 270 patients from 150. The three arms enrolling patients with DLBCL will now enroll 60 patients each, and the two arms enrolling patients with follicular lymphoma will now enroll 45 patients each. This expansion will enable more precision around the level of activity in each patient population, which will provide guidance for determining next steps in each population and the statistical design of potential subsequent studies. Pending abstract submission and acceptance, the Company plans to present a second study update at the ASH (Free ASH Whitepaper) Annual Meeting in late 2016.

Epizyme recently expanded the number of arms in the phase 2 study in adult patients with certain genetically defined solid tumor (INI1-negative tumors, SMARCA4-negative tumors or synovial sarcomas) to five arms from three due to a higher accrual of patients with certain types of INI1-negative tumors than it anticipated. The two arms enrolling patients with rhabdoid tumors and synovial sarcomas remain unchanged. A third arm will continue to enroll patients with other INI1-negative tumors, and the Company has now separated out two specific INI1-negative cohorts from the third arm. One arm will enroll patients with renal medullary carcinoma and another will enroll patients with epithelioid sarcoma. Pending abstract submission and acceptance, the Company plans to present preliminary data from the phase 2 adult solid tumor study at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in late 2016.

The phase 1 dose-escalation and expansion study of tazemetostat in pediatric patients with certain INI1-negative tumors, including rhabdoid tumors and synovial sarcomas, is enrolling well, and the study has escalated to the second dose level.
Expand Tazemetostat Program

In May, the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application for tazemetostat for the treatment of adult patients with mesothelioma characterized by BAP1 loss-of-function. The Company plans to initiate a phase 2 trial in patients with mesothelioma in the third quarter of 2016.

Earlier today, Epizyme announced that it has entered into a collaboration agreement with the Lymphoma Academic Research Organisation (LYSARC) for the first planned combination trial of tazemetostat. LYSARC is the operational arm of the Lymphoma Study Association, a premier cooperative French lymphoma group. This phase 1b/2 study will evaluate tazemetostat administered together with R-CHOP as a front-line therapy for elderly, high-risk patients with DLBCL, and is expected to begin in mid-2016.

Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference in April further characterized the dosing and administration of tazemetostat. The findings show that tazemetostat is only a weak inducer of CYP3A-mediated metabolism, suggesting a low potential interaction with other treatments metabolized through this pathway. Pharmacokinetic data presented at that meeting also show that tazemetostat can be dosed with or without food. These findings further guide tazemetostat development as a monotherapy and in combination regimens.
Growth Discovery Pipeline

Epizyme scientists continue to advance the development of small molecule inhibitors against five targets that have been selected and prioritized for research.
Maintain Established Leadership Position

Epizyme added strength to its leadership team with new hires: Matthew Ros as Chief Operating Officer, Susan Graf as Chief Business Officer, Jeannie Chu as Vice President of Program and Portfolio Management and Michael Boretti, Ph.D. as Vice President of Business Development.
Q1 2016 Financials Results and Guidance

Collaboration revenue was $0.5 million for the quarter ended March 31, 2016, compared to $0.9 million for the same period last year. The period-over-period decrease reflects increased recognition of deferred revenue from upfront payments from the Celgene collaboration in the first quarter of 2016 offset by decreased recognition of deferred revenue from upfront payments and research and development revenue related to the GlaxoSmithKline collaboration compared to the first quarter of 2015 as no revenue was recognized with respect to the GSK collaboration in the first quarter of 2016.

Research and development (R&D) expenses were $17.7 million for the quarter ended March 31, 2016, compared to $57.1 million for the first quarter of 2015. The period-over-period decrease was driven by the first quarter 2015 payment to Eisai of $40.0 million related to the reacquisition of the worldwide rights, excluding Japan, to tazemetostat, and was partially offset by increased spending on the tazemetostat clinical development program.

Epizyme expects that R&D expenses will increase in 2016, when compared to 2015. The planned increase is primarily related to the development costs of tazemetostat, including Epizyme’s trials in patients with non-Hodgkin lymphoma and adult and pediatric patients with certain genetically defined solid tumors, as well as planned combination studies in patients with DLBCL and the planned study in patients with mesothelioma. In addition, discovery and preclinical research costs are expected to increase as the Company advances its wholly owned small molecule programs against five novel targets and continues the research efforts under its Celgene collaboration.

General and administrative (G&A) expenses were $5.8 million for the quarter ended March 31, 2016, compared to $5.2 million for the same period last year. The increase in G&A expense was largely due to higher professional services costs and personnel-related expenses associated with the expansion of Epizyme’s operations. Epizyme expects that G&A spend will increase in 2016 as compared to 2015 due to increases in staffing and infrastructure to support expanded clinical trial activities, increased research investment and other expanded operational activities, including increased intellectual property costs.

Net loss was $22.9 million for the quarter ended March 31, 2016, compared to a net loss of $61.3 million for the quarter ended March 31, 2015.

Cash and cash equivalents were $312.7 million as of March 31, 2016, compared with $208.3 million as of December 31, 2015. This increase in cash was driven by the Company’s January 2016 financing.
Financial guidance from Epizyme states that the Company believes its cash and cash equivalents as of March 31, 2016 will be sufficient to fund the Company’s planned operations through at least the end of 2017.

On May 9, 2016 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq: EGRX) reported its financial results for the first quarter ended March 31, 2016 (Press release, Eagle Pharmaceuticals, MAY 9, 2016, View Source [SID:1234512110]). Highlights of and subsequent to the first quarter of 2016 include:

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Business Highlights:

Bendeka was launched January 28, 2016 by Eagle’s marketing partner, Teva Pharmaceutical Industries (Teva); total market share, as of May 6, 2016, was 71% and 77% in core hospital outpatient and clinic segments combined (representing 70% of the total market);
Eagle entered into an agreement with the National Institutes of Health (NIH)/National Institute on Drug Abuse (NIDA) to explore the use of Ryanodex in the treatment of hyperthermia related to MDMA (Ecstasy) and Methamphetamine intoxication;
Eagle entered into an agreement to divest diclofenac-misoprostsol to a third party in exchange for $1.75 million and a 25% royalty on net profits for five years; and,
Eagle completed its first quarter with an internal salesforce fully focused on commercialization of Eagle’s in-market products.
Financial Highlights:

Total revenue was $29.6 million during the first quarter of 2016 compared to $36.3 million for the three months ended March 31, 2015;
Product sales increased to $14.1 million during the first quarter of 2016 compared to $3.1 million for the three months ended March 31, 2015;
Sales of Ryanodex grew 5% quarter over quarter to $1.9 million during the first quarter of 2016;
Net loss was $896,000, or $0.06 per basic and diluted share, compared to net income of $19.7 million, or $1.38 per basic and $1.31 per diluted share, for the three months ended March 31, 2016 and 2015, respectively; and,
Cash and cash equivalents were $78.3 million as of March 31, 2016.
"Our business outlook for the Company remains bright. Our bendamustine product family offers significant opportunity for growth and is being accepted well by physicians and patients. Assuming bendamustine generics do not come to market, and with Bendeka gaining momentum, based on its product profile which customers seem to prefer, we believe Bendeka is on track to reach Teva’s and our shared goal of 90% market share or greater and will be an important earnings driver for Eagle for years to come," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"In addition to our other product candidates, we believe Ryanodex has the potential for multiple additional clinical indications. These opportunities in treating exertional heat stroke and ecstasy and methamphetamine intoxication, if approved, would open up significant new markets for the product. We are encouraged by the potential of our products to deliver solutions that address life-threatening conditions and improve treatment outcomes and look forward to upcoming milestones that we expect will drive meaningful earnings growth," concluded Tarriff.

First Quarter 2016 Financial Results

Total revenue for the three months ended March 31, 2016 was $29.6 million, as compared to $36.3 million for the three months ended March 31, 2015. A summary of total revenue is outlined below:

Three Months Ended
March 31, Increase/(Decrease)
2016 2015
(in thousands)
Product sales $ 14,122 $ 3,056 $ 11,066
Royalty income 9,469 3,253 6,216
License and other income 6,000 30,000 (24,000 )
Total revenue $ 29,591 $ 36,309 $ (6,718 )

Product sales increased $11.1 million to $14.1 million in the first quarter of 2016 driven by $10.3 million in net product sales of Bendeka, 5% growth in Ryanodex net product sales to $1.9 million, $0.9 million in net sales of Docetaxel and increases in net sales of Diclofenac-misoprostol, offset by a decrease in Argatroban product sales to our commercial partners.

The $6.2 million increase in royalty income to $9.5 million was driven by the launch of Bendeka during the first quarter of 2016.

License and other income in the three months ended March 31, 2016 was $6 million compared with $30 million in the prior year quarter. This $6 million reflects revenue previously deferred from the 2010 sale of a non-core asset subject to a claw back provision, which has now expired.

Cost of revenue increased by $8.6 million to $14.5 million in the three months ended March 31, 2016 from $5.9 million in the three months ended March 31, 2015. This $8.6 million net increase resulted primarily from the cost of Bendeka product sales, Docetaxel and Diclofenac-misoprostol, offset by a decrease in cost of revenue for Ryanodex due to spoiled inventory, and lower Argatroban product sales.

Research and development expenses increased by $0.4 million to $6.7 million in the three months ended March 31, 2016, compared to $6.3 million in the prior year quarter. The increase is due primarily to the successful completion of the clinical treatment portion of the safety and efficacy study of Ryanodex for exertional heatstroke, investment in Kangio and other pipeline products, and higher R&D personnel costs offset by a decrease in spending related to bendamustine.

SG&A expenses were $11 million in the first quarter of 2016 compared to $4 million in the three months ended March 31, 2015. Personnel-related expenses accounted for the bulk of the $7 million increase and were due to overall expansion of the business.

Net loss for the first quarter was $896,000, or $0.06 per basic share and diluted share, compared to a net income of $19.7 million, or $1.38 per basic and $1.31 per diluted share in the three months ended March 31, 2015, as a result of the factors discussed above.

Liquidity

As of March 31, 2016, the Company had $78.3 million in cash and cash equivalents; $15 million in receivables due from Teva; $200.3 million in additional paid in ca

On May 9, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the first quarter ended March 31, 2016 (Press release, Dynavax Technologies, MAY 9, 2016, View Source [SID:1234512109]).

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The Company had $166.8 million in cash, cash equivalents and marketable securities as of March 31, 2016, compared to $196.1 million at December 31, 2015. The net loss for the first quarter of 2016 was $27.0 million, compared to $26.2 million for the first quarter of 2015.

First Quarter Financials

Total revenues for the three months ended March 31, 2016 increased by $0.3 million, or 50%, compared to the same period in 2015.

Research and development expenses for the first quarter decreased by $2.2 million, or 10%, compared to the same period in 2015, reflecting an increase in employee headcount and activities in preparation for the anticipated commercial launch of HEPLISAV-B and a reduction in outside services expense due to lower activity related to HBV-23 following its completion in the fourth quarter of 2015.

General and administrative expenses for the three months ended March 31, 2016, increased by $3.3 million, or 68%, compared to the same period in 2015, as we added headcount and addressed information technology systems and other infrastructure needs in preparation for the anticipated commercial launch of HEPLISAV-B.

The net loss for the quarter ended March 31, 2016 was $27.0 million, or $0.70 per basic and diluted share compared to $26.2 million, or $0.97 per basic and diluted share for the quarter ended March 31, 2015.

Recent Progress

At the end of the quarter, the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for HEPLISAV-B, the company’s vaccine for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established December 15th as the Prescription Drug User Fee Act (PDUFA) action date for the BLA.

"We are focused on working with the FDA to obtain approval of HEPLISAV-B before year end and on preparing for launch, including preparation for an advisory panel in case one is called, hiring of key commercial personnel, market and pricing research and manufacturing of launch inventory," said Dynavax Chief Executive Officer, Eddie Gray.

In April, we reported additional details from the HBV-23 pivotal Phase 3 HEPLISAV-B trial at the National Foundation for Infectious Diseases’ (NFID) 19th Annual Conference on Vaccine Research (ACVR).

Also in April, we presented encouraging additional data from Part 1 of the Phase 1/2 study evaluating our lead immunotherapy product candidate, SD-101, in lymphoma patients. The clinical data, along with preclinical SD-101 data, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.