On May 8, 2018 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, reported its first quarter 2018 financial results for the period ended March 31, 2018 (Press release, Merrimack, MAY 8, 2018, View Source [SID1234526268]).

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"At Merrimack, we set out to design targeted solutions with pharmacological properties to match our team’s understanding of cancer pathways and drug metabolism. We have been focused on executing this strategy as we advance the ten wholly-owned programs across our clinical and preclinical pipeline, each addressing biomarker-defined cancers," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "We look forward to our three upcoming clinical readouts: randomized Phase 2 data for istiratumab (MM-141) in pancreatic cancer and seribantumab (MM-121) in non-small cell lung cancer and Phase 1 data for MM-310 in solid tumors."

First Quarter and Recent Highlights

Key events from the first quarter and more recently include:

Appointment of Lee Newcomer, M.D., M.H.A., former Senior Vice President for Oncology and Genetics and Chief Medical Officer at UnitedHealthcare and board-certified medical oncologist, to Merrimack’s Scientific Advisory Board (SAB). Dr. Newcomer, with his perspective on medical oncology and patient access, joins distinguished experts in precision oncology, bioengineering, drug discovery and clinical development on Merrimack’s SAB; and

Presentation of preclinical data at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Merrimack hosted four poster sessions, highlighting preclinical data from MM-310 as well as other preclinical programs currently in development.
Upcoming Milestones

Merrimack anticipates the following upcoming clinical milestones:

Top-line results in the first half of 2018 from the CARRIE study, an event-driven, randomized Phase 2 clinical trial evaluating istiratumab (MM-141) added to standard of care in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1;

Top-line results in the second half of 2018 from the SHERLOC study, an event-driven, randomized Phase 2 clinical trial evaluating seribantumab (MM-121) added to standard of care in patients with heregulin positive non-small cell lung cancer; and

Safety data and maximum tolerated dose in the second half of 2018 from the Phase 1 clinical study of MM-310 in patients with solid tumors.
First Quarter 2018 Financial Results

The following summarizes Merrimack’s financial results for the three months ended March 31, 2018:

Research and development expenses for the three months ended March 31, 2018 were $13.1 million, compared to $21.6 million for the three months ended March 31, 2017. Research and development spending for the first quarter of 2018 was lower versus the comparable period in 2017, primarily due to Merrimack’s refocused clinical and preclinical pipeline;

General and administrative expenses for the three months ended March 31, 2018 were $4.3 million, compared to $5.6 million for the three months ended March 31, 2017. General and administrative spending for the first quarter of 2018 was lower versus the comparable period in 2017, primarily due to a decrease in corporate expenses related to headcount levels following the asset sale to Ipsen S.A.;

Net loss from operations for the three months ended March 31, 2018 was $17.8 million, or $1.33 per share, compared to a net loss from continuing operations of $28.7 million, or $2.20 per share, for the three months ended March 31, 2017;

As of March 31, 2018, Merrimack had cash and cash equivalents and marketable securities of $76.3 million, compared to $93.4 million as of December 31, 2017; and

As of March 31, 2018, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.
Financial Outlook

Merrimack continues to believe that its cash and cash equivalents and marketable securities of $76.3 million as of March 31, 2018 and certain potential net milestone payments anticipated from Shire will be sufficient to fund its planned operations into the second half of 2019.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Tuesday, May 8, 2018 at 8:30 am ET, to provide an update on its operational progress and a summary of these financial results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 1596995. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

Corcept Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Corcept Therapeutics, 2018, MAY 8, 2018, View Source [SID1234527942]).

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On May 8, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the first quarter ended March 31, 2018 and recent company developments (Press release, Manhattan Pharmaceuticals, MAY 8, 2018, View Source [SID1234526205]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2018 is off to a great start as we continue to advance our major pivotal programs and bolster our product pipeline, most recently with the addition of a BTK inhibitor program. As we move into the second quarter and the remainder of the year, we look forward to the announcement of topline data from our UNITY-CLL trial, completion of enrollment into the current cohorts of the UNITY-NHL study, final MS Phase 2 data, significant enrollment in our MS phase 3 program as well as filing decisions related to the Company’s first BLA/NDA later in the year." Mr. Weiss continued, "We believe 2018 will be a pivotal year for the Company as approval pathways across multiple indications become clearer and position us for future success."

First Quarter and Recent Highlights

BTK License: Entered into an exclusive global license agreement with Jiangsu Hengrui Medicine Co., Ltd. (or "Hengrui") to obtain worldwide rights, excluding Asia but including Japan, for the development of Hengrui’s Bruton’s Tyrosine Kinase (BTK) inhibitor program, including the lead candidate, TG-1701.
Umbralisib Lancet Publication: Results from the Phase 1 first-in-human study of umbralisib (TGR-1202), the Company’s novel once-daily PI3K delta inhibitor, were published in The Lancet Oncology.
TG-1601 Preclinical Data: Presented the first preclinical data from TG-1601, the Company’s novel BET inhibitor, at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
Ublituximab Data in Multiple Sclerosis: Presented clinical and MRI data from the Phase 2 trial of ublituximab (TG-1101) in RMS at the 3rd Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 and the American Academy of Neurology (AAN) 70th Annual Meeting.

Remaining 2018 Milestones

Present top-line overall response rate data from the UNITY-CLL Phase 3 trial of ublituximab plus umbralisib in front line and relapsed/refractory Chronic Lymphocytic Leukemia (CLL).
Prepare and potentially file the Company’s first BLA and/or NDA.

Complete enrollment in the current arms of the UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.
Present updated clinical data from ongoing oncology trials and final results from the Phase 2 trial of ublituximab in Multiple Sclerosis (MS) at major medical meetings during 2018.

Financial Results for the First Quarter 2018

Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $109.2 million as of March 31, 2018. Pro-forma cash, cash equivalents, investment securities, and interest receivable as of March 31, 2018 (excluding our second quarter 2018 operations) are approximately $123.3 million, after giving effect to $14.1 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the second quarter of 2018.

Other R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $32.2 million for the three months ended March 31, 2018 compared to $20.4 million for the three months ended March 31, 2017. Included in other research and development expense for the three months ended March 31, 2018 was $14.5 million of clinical trial expense and $9.6 million of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The current period increase in Other R&D expenses is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.

●Other G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $2.1 million for the three months ended March 31, 2018 as compared to $1.3 million for the three months ended March 31, 2017. Other G&A expenses for the three months ended March 31, 2018 remained relatively flat compared to the first quarter of 2017, and we expect Other G&A expenses to increase modestly through the remainder of 2018.

●Net Loss: Net loss was $41.5 million for the three months ended March 31, 2018, compared to a net loss of $27.7 million for the three months ended March 31, 2017. Excluding non-cash items the net loss for the three months ended March 31, 2018 was approximately $33.2 million.

●Financial Guidance: Net cash utilized for operating activities during the three months ended 2018 was approximately $28.0 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of March 31, 2018, inclusive of the proceeds raised subsequent to the first quarter, will be sufficient to fund the Company’s planned operations through mid-2019.

Conference Call Information

The Company will host an investor conference call today, May 8, 2018, at 8:30am ET, to discuss the Company’s first quarter 2018 financial results and provide a business outlook for the remainder of 2018.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics First Quarter 2018 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

On May 8, 2018 Reata Pharmaceuticals, Inc. (Nasdaq:RETA), a clinical-stage biopharmaceutical company, provided an update on the Company’s product development programs reported financial results for the first quarter ended March 31, 2018 (Press release, Reata Pharmaceuticals, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347933 [SID1234526235]).

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Product Development Updates

CATALYST Trial of Bardoxolone Methyl in CTD-PAH

The primary endpoint for the Phase 3 CATALYST trial in CTD-PAH is the placebo-corrected change in six-minute walk distance (6MWD) following six months of treatment. The sample size range for the CATALYST trial was based upon data from the Phase 2 LARIAT trial and set at a range of 130 to 200 patients. The final sample size is determined by a prospectively-defined, pooled, and blinded sample size recalculation occurring after enrollment of at least 100 patients. The purpose of this analysis is to preserve statistical power, and it incorporates baseline characteristics and observed 6MWD variability from enrolled patients. The sample size recalculation was recently performed and indicated that a sample size of 200 patients will be sufficient to support the initial statistical assumptions and preserve statistical power of the study. The sample size recalculation was performed on a blinded basis, and there was no assessment of treatment effect. Accordingly, no statistical penalty was incurred toward the primary endpoint of the CATALYST study. As a result of the sample size recalculation, Reata expects that it will require at least 12 months to complete enrollment of the study, and now expects top-line data from CATALYST during the first half of 2020.

Phase 2 PHOENIX Trial of Bardoxolone Methyl in Rare Forms of Chronic Kidney Disease (CKD)

We are completing enrollment earlier than planned in the autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy, and type 1 diabetic CKD (T1D CKD) cohorts of PHOENIX. We expect enrollment in all three cohorts to be complete by the end of May and full primary endpoint data from these three rare forms of CKD to be available during the third quarter of 2018. Full primary endpoint data from the focal segmental glomerulosclerosis cohort are expected to be available in the first half of 2019.

Interim data for the ADPKD and IgA nephropathy cohorts will be presented in a late-breaking abstract at the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA) meeting in Copenhagen on May 25, 2018 in an abstract entitled "Initial Results from a Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease and IgA Nephropathy." Reata’s data presentations from other clinical trials with bardoxolone methyl at ERA-EDTA will include:

Effect of Bardoxolone Methyl on Urinary Albumin in Patients with Type 2 Diabetes and Chronic Kidney Disease: Post-hoc Analyses from BEAM and BEACON
Bardoxolone Methyl Prevents eGFR Decline in Patients with Chronic Kidney Disease Stage 4 and Type 2 Diabetes ─ Post-hoc Analyses from BEACON
Two-Year Durability of Improvements in eGFR with Bardoxolone Methyl in Patients with Pulmonary Arterial Hypertension: The LARIAT Study
Registrational Phase 3 Portion of the CARDINAL Trial of Bardoxolone Methyl in Alport Syndrome

Enrollment in the pivotal Phase 3 portion of the CARDINAL trial of bardoxolone methyl in Alport syndrome is proceeding as planned. The clinical trial is expected to be fully enrolled in the second half of 2018, with top-line data available in the second half of 2019. One-year eGFR withdrawal data, also known as the "retained benefit" analysis, from the Phase 2 portion of CARDINAL will be available in the third quarter of this year. In addition, Reata’s development partner, Kyowa Hakko Kirin, is planning to initiate a pivotal Phase 3 clinical trial in diabetic CKD in Japan during 2018.

Registrational Portion of MOXIe Trial of Omaveloxolone in Friedreich’s Ataxia

Enrollment in the pivotal Part 2 of the Phase 2 MOXIe trial of omaveloxolone in Friedreich’s ataxia is proceeding as planned. The clinical study is expected to be fully enrolled in the second half of 2018, with top-line data available in the second half of 2019.

Upcoming Milestones

Interim Phase 2 PHOENIX data in ADPKD and IgA nephropathy at ERA-EDTA on May 25th
One-year retained eGFR benefit data for CARDINAL Phase 2 patients in the third quarter of 2018
Full 12-week PHOENIX data in ADPKD, IgA nephropathy, and T1D CKD during the third quarter of 2018
Launch of pivotal trial in diabetic CKD by Kyowa Hakko Kirin in Japan during 2018
Full 12-week PHOENIX data in FSGS in the first half of 2019
Pivotal data from the CARDINAL trial in the second half of 2019
Pivotal data from the MOXIe trial in the second half of 2019
Pivotal data from the CATALYST trial in the first half of 2020
Financial Highlights

The Company incurred operating expenses of $28.1 million for the quarter ended March 31, 2018, with research and development accounting for $21.4 million. This compares to operating expenses of $19.9 million for the same period of the year prior, when research and development accounted for $14.6 million. Net income of $4.1 million or $0.16 per share was reported by the Company for the quarter ended March 31, 2018. This compares to net loss of $7.1 million or $0.32 per share in the same period of the year prior. The increase in net income and net income per share is primarily due to revenue of $25.1 million related to a milestone payment that we expect to receive from Kyowa Hakko Kirin in 2018 that was partially recognized in accordance with newly-adopted revenue recognition requirements under Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (Topic 606) issued by the Financial Accounting Standards Board. The increase in revenue under the new guidance resulted in increases of $25.1 million in net income and $0.96 in basic net income per share for the three months ended March 31, 2018.

As of March 31, 2018, the Company had $105.9 million in cash and cash equivalents. We believe our existing cash and cash equivalents, in combination with available debt and the expected milestone payment from Kyowa Hakko Kirin, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through registrational data from both CARDINAL and MOXIe in the second half of 2019.

Reata management will be hosting a conference call to discuss our development programs on May 9, 2018 at 8:00 a.m. ET at the following:

CONFERENCE CALL INFORMATION

Date: Wednesday May 9, 2018
Time: 8:00 a.m. ET
Audience Dial-in (toll-free): (844) 348-3946
Audience Dial-in (international): (213) 358-0892
Passcode: 8266998
Webcast Link: View Source

On May 8, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported financial results for the first quarter ended March 31, 2018, and provided an update on recent developments (Press release, Bellicum Pharmaceuticals, MAY 8, 2018, View Source [SID1234526251]).

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"We remain very encouraged with interim results from our BPX-501 program in malignant and nonmalignant pediatric patients, and remain on track for filing of MAAs in the European Union in 2019," said Bellicum’s President & CEO Rick Fair. "We are also working to expand the BPX-501 opportunity into the U.S. and into the adult stem cell transplant population with the planned initiation of two new clinical trials later this year. In our BPX-601 GoCAR-T program, we reported early promising first-in-human data on CAR-T cell expansion with the use of our iMC activation switch. We look forward to sharing data readouts on all our clinical programs during 2018, and providing further guidance on our plans to advance two new dual-switch controllable CAR-T candidates into clinical studies."
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
Clinical Hold Lifted by FDA on U.S. Studies of BPX-501
The Company is now working with U.S. clinical sites to resume patient recruitment based on amended study protocols, including guidance on monitoring and management of neurologic adverse events. The FDA clinical hold did not affect the BP-004 registration trial in Europe.

BPX-501 E.U. Registration Trial Enrollment Complete
Enrollment was recently completed in the treatment arm of the BP-004 E.U. registration trial in malignant and nonmalignant pediatric patients undergoing haploidentical hematopoietic stem cell transplant (haplo-HSCT). The Company expects to have topline data at the end of 2018, followed by a readout of comparative data from its ongoing C-004 observational study in children receiving a matched unrelated donor (MUD) transplant without BPX-501. Bellicum expects to file for E.U. approvals of BPX-501 and rimiducid in 2019.
BPX-501 Interim Survival Results Reported
In March, the Company announced favorable interim results in pediatric patients with acute myeloid leukemia (AML), with overall survival of 97.3% in patients with a median follow-up of over one year. The Company also reported new updated interim data in pediatric patients with primary immunodeficiencies (PIDs) undergoing a curative haplo-HSCT with BPX-501. Abstracts providing more comprehensive interim data on these patients have been accepted for presentation at the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held in Stockholm in June.

CAR-T and TCR Phase 1 Studies Enrolling
Bellicum and its collaborators are currently enrolling Phase 1 clinical trials of three CAR-T and TCR programs featuring its industry-leading cellular control technology: BPX-601, BPX-701, and an academic collaborator’s CaspaCIDe-enabled CD19 CAR-T. The Company expects to report preliminary findings from all three studies at medical meetings later this year. BPX-601, the Company’s first GoCAR-T product candidate-differentiated by the inclusion of its proprietary iMC activation switch-is the first controllable CAR-T to enter clinical trials and is being studied in adults with nonresectable pancreatic cancer who test positive for prostate stem cell antigen (PSCA). The Company recently reported that the

1

Exhibit 99.1

first patient dosed with rimiducid in the BPX-601 trial showed a robust expansion of circulating BPX-601 cells following a single dose of rimiducid, providing initial clinical proof of concept of the iMC activation switch. As enrollment continues, the Company is preparing to amend the trial to include additional PSCA-expressing tumors. In the Phase 1 study with BPX-701, Bellicum is working to add clinical sites to accelerate enrollment.

Progressing Next-Generation Dual-Switch Preclinical Programs
Leveraging its innovative technology platform, Bellicum has created next-generation controllable CAR-Ts that incorporate both activation and safety switches in the same T cell. At the AACR (Free AACR Whitepaper) Annual Meeting in April, the Company presented promising preclinical results highlighting the ability to manage expansion, persistence and safety of tumor antigen-specific CAR-T cells, potentially allowing for more aggressive anti-tumor therapies. The Company has nominated two new dual-switch CAR-Ts for clinical trials next year, and will provide additional details on these programs later this year.

Underwritten Public Offering of Common Stock
In April, Bellicum completed a public offering of 9.2 million shares, including 1.2 million shares sold under the underwriters’ option to purchase additional shares, at $7.50 per share. The aggregate offering size was $69.0 million before deducting the underwriting discounts and commissions and other offering expenses.

First Quarter 2018 Financial Results

Cash Position and Guidance: Bellicum ended the quarter on March 31, 2018 with cash, restricted cash and investments totaling $88.0 million, compared to $106.5 million at December 31, 2017. Based on current operating plans, Bellicum expects that current cash resources, including proceeds from its April 2018 public offering, will be sufficient to meet operating requirements through the end of 2019.

R&D Expenses: Research and development expenses were $16.5 million for the quarter ended March 31, 2018, compared to $15.3 million for the comparable period in 2017. The increase of approximately $1.2 million is primarily due to increased general research and development and collaboration costs of $1.9 million and increased costs related to BPX-701 of $0.2 million, partially offset by reduced costs related to BPX-501 of $0.9 million. Costs related to BPX-601 were comparable in each of the three-month periods.

G&A Expenses: General and administrative expenses were $5.7 million for the first quarter ended March 31, 2018, compared to $5.9 million during the comparable period in 2017. The decrease in G&A expenses in 2018 is primarily due to severance costs related to former executive officers incurred in the three months ended March 31, 2017.

Net Loss: Bellicum reported a net loss of $22.8 million during the first quarter of 2018 and $22.0 million during the comparable period in 2017. The results include non-cash, share-based compensation charges and depreciation of $5.0 million and $4.1 million in the first quarters of 2018 and 2017, respectively.

Shares Outstanding:

Bellicum had 34,288,556 and 42,873,045 shares of common stock outstanding as of March 31, 2018 and April 30, 2018, respectively. The increase in the number of outstanding shares was primarily attributable to the public offering of 9.2 million shares in April.

About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should

2

Exhibit 99.1

uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.

About BPX-601
BPX-601 is a GoCAR-T product candidate containing Bellicum’s proprietary inducible MyD88/CD40, or iMC, activation switch, designed to treat solid tumors expressing prostate stem cell antigen, or PSCA. Preclinical data show enhanced T cell proliferation, persistence and in vivo anti-tumor activity compared to traditional CAR-T therapies. In addition to pancreatic cancer, PSCA is expressed in several other solid tumor indications, including: gastric, esophageal, cholangiocarcinoma, glioblastoma, prostate and bladder cancers. The Company plans to expand the clinical development of BPX-601 to include additional PSCA expressing cancer types.

About BPX-701
BPX-701 is a high affinity T cell receptor product candidate designed with the CaspaCIDe safety switch. In preclinical studies, PRAME-specific clones showed high reactivity against a panel of PRAME positive tumor cell lines, metastatic melanoma, sarcomas and neuroblastoma tissues. In vitro study data showed that BPX-701 demonstrated strong affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells, as well as complete elimination of BPX-701 cells in response to rimiducid.