Navidea Biopharmaceuticals to Host Fourth Quarter 2022 Earnings Conference Call and Business Update

On March 15, 2023 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Tuesday, March 21, 2023 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Navidea Biopharmaceuticals, MAR 15, 2023, View Source [SID1234628790]).

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Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

Event: Fourth Quarter 2022 Earnings Conference Call and Business Update
Date: Tuesday, March 21, 2023
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13736745
Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

Moleculin to Report Full Year 2022 Financial Results on March 22, 2023 and Host Conference Call and Webcast

On March 15, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported that it will report its financial results for the full year December 31, 2022 after market close on Wednesday, March 22, 2023 (Press release, Moleculin, MAR 15, 2023, https://moleculin.com/moleculin-to-report-full-year-2022-financial-results-on-march-22-2023-and-host-conference-call-and-webcast/ [SID1234628789]). Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results on Thursday, March 23rd at 8:30 AM ET.

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The call will be hosted by members of Moleculin’s leadership team, Walter Klemp, Chairman and Chief Executive Officer, Dr. John Paul Waymack, Senior Chief Medical Officer, and Jonathan Foster, Executive VP & Chief Financial Officer. Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.

MaxCyte Reports Fourth Quarter and Full Year 2022 Financial Results

On March 15, 2023 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and to support innovative, cell-based research, reported its fourth quarter and full year ended December 31, 2022, financial results and provided initial 2023 revenue guidance (Press release, MaxCyte, MAR 15, 2023, View Source [SID1234628788]).

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Fourth Quarter and Full Year Highlights

·

Total revenue of $12.4 million in the fourth quarter of 2022, an increase of 22% over the fourth quarter of 2021.

·

Core business revenues grew 4% in the fourth quarter of 2022, with revenue growth from cell therapy customers growing 4% and revenue from drug discovery customers growing by 5%, over the fourth quarter of 2021.

·

Total revenue of $44.3 million for the full year 2022, an increase of 31% over the full year 2021.

·

Full year 2022 core business revenues grew 26%, led by cell therapy revenue growth of 33%, and revenue from drug discovery growing 8%.

·

Initial 2023 guidance for total revenue growth of 21% to 26% over 2022, including core revenue growth of 20% to 25% over 2022, and Strategic Platform License (SPL) program-related revenue of approximately $6 million.

·

Total cash, cash equivalents and short-term investments were $227.3 million as of December 31, 2022.

"We are pleased with our strong progress and performance in 2022 and look forward to continuing this positive momentum into 2023. Over the course of the year, we have made significant investments in our people, manufacturing capacity, and R&D infrastructure, which positions us well for our next stage of growth," said Doug Doerfler, President and CEO of MaxCyte.

"Our portfolio of partnerships continued to grow throughout 2022, having announced three new SPL partnerships as well as the recent addition of Catamaran Bio as a partner in early 2023. We also entered into a partnership with Vertex following the transfer of the exa-cel program from CRISPR. The partnership maintains our role in this program, for which Vertex is currently seeking regulatory marketing approval in the United States and Europe for Sickle Cell Disease and Beta-Thalassemia. We are continuing to see our partners make strong progress across their clinical programs and are focused on providing them with the in-house manufacturing and regulatory support that they will require as they move towards commercialization. Our partnership pipeline remains robust and growing as we begin 2023 and we are excited to see our partners achieve upcoming milestones and move the cell therapy industry forward."

The following table provides details regarding the sources of our revenue for the periods presented

Three Months Ended

Year Ended

December 31,

(Unaudited)

December 31,

(Unaudited)

2022

2021

%

2022

2021

%

(in thousands, except percentages

Cell therapy

$

7,544

$

7,264

4%

$

30,546

$

22,984

33%

Drug discovery

3,026

2,885

5%

9,100

8,395

8%

Program-related

1,854

3

NM*

4,616

2,515

83%

Total revenue

$

12,424

$

10,152

22%

$

44,262

$

33,894

31%

* Not Meaningful (NM)

Operational Highlights

·

Ended the year with 18 SPL partnerships, with the addition of partnerships with Intima Bioscience, LG Chem, and Curamys in 2022. With the addition of an SPL partnership with Catamaran Bio in early 2023, the total number of partnerships now stands at 19. Vertex Pharmaceuticals will use MaxCyte’s Flow Electroporation technology and ExPERT platform to support the gene-edited hemoglobinopathy cell therapy exa-cel, formerly known under CRISPR as CTX001. We entered into an SPL partnership with Vertex in 2022 for this transferred program. In addition, we retained our partnership with CRISPR therapeutics supporting CRISPR/Cas9-based therapies in immuno-oncology.

·

As of December 31, 2022, our 18 active SPL partner agreements allowed for over 125 potential programs; 16 of which were active programs currently in the clinic (defined as programs with at least a cleared IND or equivalent). If all potential programs successfully progress through the clinic to commercial approval, we estimate aggregate potential to generate pre-commercial milestone payments to us of over $1.55 billion in addition to sales-based commercial revenue due to us under existing agreements. At the end of 2021, there were 15 SPL partnerships covering over 95 programs with total potential pre-commercial milestones exceeding $1.25 billion.

·

As of December 31, 2022, we had over 600 instruments placed with customers, compared to over 500 instruments at the end of 2021.

·

Launched the ExPERT branded VLxTM, our large-scale Flow Electroporation platform.

·

Completed and occupied our new, 67,000 square foot, state of the art headquarters in Maryland’s I-270 biotech corridor, significantly increasing our in-house manufacturing capacity, as well as research and process development lab space.

·

Appointed Patrick J. Balthrop, Sr. to our board of directors as a non-executive member. Mr. Balthrop will also serve on the nominating and corporate governance committees of our board of directors.

In addition to revenue, management regularly reviews key business metrics to evaluate our business, measure performance, identify trends affecting our business, formulate financial projections and make strategic decisions. As of the dates presented, these key metrics were as follows

As of December 31,

2022

2021

2020*

Installed base of instruments (sold or leased)

>600

>500

>400

Number of active SPL partnerships

18

15

12

Total number of licensed clinical programs (SPL partnerships only)

>125

>95

>75

Total number of active licensed clinical programs under SPL partnerships currently in the clinic **

16

15

7

Total potential pre-commercial milestones under SPL partnerships

>$1.55 billion

>$1.25 billion

>$950 million

* Amounts presented as of December 31, 2020, give effect to one SPL entered into and additional INDs cleared in January 2021.

** Number of licensed clinical programs under SPLs are by number of product candidates and not by indication.

Fourth Quarter 2022 Financial Results

Total revenue for the fourth quarter of 2022 was $12.4 million, compared to $10.2 million in the fourth quarter of 2021, representing growth of 22%.

Core business revenue (instruments and disposables to cell therapy and drug discovery customers and excluding program-related revenue) was $10.6 million in 2022, compared to core business revenue of $10.1 million in 2021, representing growth of 4%, including 4% revenue growth from cell therapy customers and 5% revenue growth from drug discovery customers.

Our SPL program-related revenue was $1.9 million in the fourth quarter of 2022 as compared to immaterial SPL program-related revenue in the fourth quarter of 2021.

Gross profit for the fourth quarter of 2022 was $10.9 million (88% gross margin), compared to $8.9 million (88% gross margin) in the fourth quarter of 2021.

Operating expenses for the fourth quarter of 2022 were $17.6 million, compared to operating expenses of $13.9 million in the fourth quarter of 2021. The overall increase in operating expenses was primarily driven by increases in R&D, sales, and marketing headcount and occupancy expenses related to our new corporate headquarters.

Net loss for the fourth quarter of 2022 was $4.8 million compared to net loss of $4.9 million in the fourth quarter of 2021. EBITDA, a non-GAAP measure, was a loss of $5.8 million for the fourth quarter of 2022, compared to a loss of $4.5 million for the fourth quarter of 2021; stock-based compensation expense was $3.1 million in the fourth quarter of 2022 compared to $2.4 million in the fourth quarter of 2021.

Full Year 2022 Financial Results

Total revenue for 2022 was $44.3 million, compared to $33.9 million in 2021, representing growth of 31%.

Core business revenue for 2022 was $39.6 million, compared to $31.4 million for 2021, representing growth of 26%, including 33% revenue growth from cell therapy customers and 8% revenue growth from drug discovery customers.

Our SPL program-related revenue for 2022 was $4.6 million, compared to $2.5 million in SPL program-related revenue in 2021, representing growth of 83% in 2022.

Gross profit for 2022 was $39.2 million (88% gross margin), compared to $30.2 million (89% gross margin) in the prior year.

Operating expenses for 2022 were $66.5 million, compared to operating expenses of $48.4 million in 2021. The overall increase in operating expenses was principally driven by increases in headcount, occupancy, and public company expenses.

Full year 2022 net loss was $23.6 million compared to a loss of $19.1 million in 2021; full year 2022 EBITDA was a loss of $24.8 million compared to a loss of $17.4 million in 2021; total stock-based compensation for 2022 was $11.8 million, compared to $8.0 million for 2021.

Total cash, cash equivalents and short-term investments were $227.3 million as of December 31, 2022, compared to $255.0 million as of December 31, 2021.

2023 Revenue Guidance

Management is providing initial 2023 revenue guidance for total revenue, core business revenue and SPL program-related revenue.

Management expects full year 2023 total revenue growth of between 21% and 26% over 2022 including core business revenue growth of between 20% and 25% over 2022, and SPL program-related revenue of approximately $6 million.

Webcast and Conference Call Details

MaxCyte will host a conference call today, March 15, 2023, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

MacroGenics Provides Corporate Update and 2022 Financial Results

On March 15, 2023 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and reported financial results for the year ended December 31, 2022 (Press release, MacroGenics, MAR 15, 2023, View Source [SID1234628787]).

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"Our recent presentation of encouraging, preliminary lorigerlimab data in patients with metastatic castration-resistant prostate cancer (mCRPC) at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium, together with data we previously shared regarding vobramitamab duocarmazine in mCRPC patients, supports continued development of our two potential new treatment options for men with prostate cancer," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "I am very pleased that we were able to add $250 million in non-dilutive funding over the past eight months, including $150 million during the second half of 2022 and another $100 million to date in 2023 to develop these as well as our other product candidates. Also, I believe the modifications we are making to the TAMARACK study of vobramitamab duocarmazine will lead to more rapid dose selection and benefit the molecule’s overall product profile. Finally, beyond our clinical pipeline, we continue to develop multiple pre-clinical molecules and plan to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a new antibody-drug conjugate (ADC) later this year."

Updates on Proprietary Investigational Programs

Recent progress and anticipated events related to MacroGenics’ investigational product candidates are highlighted below.

Vobramitamab duocarmazine (vobra duo), formerly known as MGC018, is an ADC that targets B7-H3, an antigen with broad expression across multiple solid tumor types and a member of the B7 family of molecules involved in immune regulation.
MacroGenics initiated the Phase 2 portion of the TAMARACK study of vobra duo in patients with mCRPC in late 2022. This study is designed to evaluate 100 patients across two experimental arms in which they receive vobra duo at either 2.0 mg/kg or 2.7 mg/kg Q4W. This study initially included a control arm in which patients received a second androgen receptor axis-targeted (ARAT) agent. The treatment landscape for patients with mCRPC has evolved with declining acceptability regarding the use of a second ARAT agent in patients who progress on earlier therapies and the approval of a radiopharmaceutical medication. Given MacroGenics’ objective to enroll TAMARACK and determine an optimal dose expeditiously, the Company has modified the trial by removing the ARAT control arm and the Phase 3 portion of the study, with regulatory approval for the modified protocol obtained to date in several countries. MacroGenics believes that removal of the control arm should allow the Company to provide a clinical update in 2024 potentially in support of a subsequent Phase 3 study in mCRPC.
MacroGenics continues to pursue a Phase 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with various advanced solid tumors.
Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule.
MacroGenics presented preliminary clinical results from a dose expansion, single arm study of lorigerlimab in patients with advanced solid tumors in a poster session at the 2023 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium in February 2023. Among the data presented, 12 of 42 patients (28.6%) with mCRPC achieved ≥ 50% prostate-specific antigen (PSA) reduction (PSA50), including nine (21.4%) who achieved ≥ 90% PSA reduction (PSA90). Nine of 35 patients (25.7%) who had measurable mCRPC achieved confirmed partial responses. The overall safety profile observed across 127 patients from multiple solid tumor expansion cohorts was manageable.
MacroGenics plans to initiate a randomized Phase 2 study of lorigerlimab in combination with docetaxel vs. docetaxel in second-line, chemotherapy-naïve mCRPC patients in the second half of 2023. A total of 150 patients are planned to be randomized 2:1. The current study design includes a primary study endpoint of radiographic progression-free survival (rPFS).
MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life.
MacroGenics continues to enroll patients in a Phase 1 dose-escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes.
As previously announced in October 2022, MacroGenics and Gilead Sciences, Inc. entered into an exclusive option and collaboration agreement to develop MGD024 and up to two additional bispecific research programs. The agreement granted Gilead the option to license MGD024 at predefined decision points during the Phase 1 study.
Other Corporate Updates

TZIELD (teplizumab-mzwv) approval. As previously announced in November 2022, the FDA approved TZIELD to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. Teplizumab was acquired from MacroGenics by Provention Bio (Provention) in 2018, pursuant to an asset purchase agreement, as amended, with specific provisions that include:
Provention is obligated to pay MacroGenics a $60 million milestone for this first approval, which was split into four $15 million payments. The first two payments were received in November 2022 and March 2023 and the two remaining payments are due June 1, 2023 and September 1, 2023.
MacroGenics is eligible to receive additional contingent payments from Provention.
Sale of TZIELD Royalty Interest for up to $200 Million. As announced last week, MacroGenics sold its royalty interest in TZIELD to a wholly-owned subsidiary of DRI Healthcare Trust (DRI). MacroGenics retains its other economic interests related to TZIELD, including future potential regulatory and commercial milestones. The Company received a $100 million upfront payment from DRI for the sale of its single-digit royalty on global net sales of TZIELD. The Company retains the right to receive a 50% share of the royalty on global net sales above a certain annual threshold. In addition, MacroGenics is eligible to receive up to $50 million from DRI upon the occurrence of pre-specified events tied to the advancement of TZIELD for the treatment of newly diagnosed T1D and may also receive an additional $50 million if TZIELD achieves a certain level of net sales.
Expanded ADC Collaboration with Synaffix. In March 2023, MacroGenics expanded its technology agreement with Synaffix, which will allow MacroGenics to gain access to Synaffix’s proprietary linker-payload platform to support up to four additional ADC molecules.
New Board Members. As previously announced in January 2023, Dr. Margaret A. Liu and Meenu Chhabra Karson were appointed to MacroGenics’ Board of Directors. Dr. Liu serves as a member of MacroGenics’ Science and Technology Committee and Ms. Karson serves as a member of the Company’s Audit Committee. Biographical information for both new Board members can be found on the Company’s website.
2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2022, were $154.3 million, compared to $243.6 million as of December 31, 2021. This cash balance did not include the $45 million receivable due from Provention or the recent $100 million payment from DRI.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $151.9 million for the year ended December 31, 2022, compared to total revenue of $77.4 million for the year ended December 31, 2021.
R&D Expenses: Research and development expenses were $207.0 million for the year ended December 31, 2022, compared to $214.6 million for the year ended December 31, 2021. The decrease was primarily related to decreased retifanlimab manufacturing costs for Incyte, and decreased costs related to discontinued studies. These decreases were partially offset by increased development, manufacturing and clinical trial costs related to vobramitamab duocarmazine, increased expenses related to discovery projects and preclinical molecules, and increased clinical expenses related to lorigerlimab and MGD024.
SG&A Expenses: Selling, general and administrative expenses were $58.9 million for the year ended December 31, 2022, compared to $63.0 million for the year ended December 31, 2021. The decrease was primarily related to decreased selling costs for MARGENZA as well as decreased legal, consulting and stock-based compensation expenses.
Net Loss: Net loss was $119.8 million for the year ended December 31, 2022, compared to net loss of $202.1 million for the year ended December 31, 2021.
Shares Outstanding: Shares of common stock outstanding as of December 31, 2022 were 61,701,467.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $154.3 million as of December 31, 2022, plus the $100 million proceeds received from DRI related to the sale of the Company’s TZIELD royalty interest, projected and anticipated future payments from partners and product revenues should extend its cash runway through 2025. The Company’s expected funding requirements reflect anticipated expenditures related to the Phase 2 TAMARACK clinical trial, the planned Phase 2 study of lorigerlimab in mCRPC as well as MacroGenics’ other clinical and preclinical studies currently ongoing.
Conference Call Information

To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on MacroGenics’ website for 30 days following the call.

MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)

December 31, 2022 December 31, 2021
Cash, cash equivalents and marketable securities $ 154,346 $ 243,616
Total assets 280,468 335,245
Deferred revenue 69,468 20,646
Total stockholders’ equity 142,013 239,618

MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)

(Amounts in thousands, except share and per share data)

2022 2021 2020
Revenues:
Collaborative and other agreements $ 119,303 $ 63,294 $ 97,764
Product sales, net 16,727 12,349 —
Contract manufacturing 13,988 — —
Government agreements 1,923 1,804 7,119
Total revenues 151,941 77,447 104,883
Costs and expenses:
Cost of product sales 3,351 2,651 —
Cost of manufacturing services 4,033 — —
Research and development 207,026 214,577 193,201
Selling, general and administrative 58,949 63,014 42,742
Total costs and expenses 273,359 280,242 235,943
Loss from operations (121,418 ) (202,795 ) (131,060 )
Other income 1,660 680 1,321
Net loss (119,758 ) (202,115 ) (129,739 )
Other comprehensive income (loss):
Unrealized gain (loss) on investments 56 (54 ) (23 )
Comprehensive loss $ (119,702 ) $ (202,169 ) $ (129,762 )

Basic and diluted net loss per common share $ (1.95 ) $ (3.37 ) $ (2.47 )
Basic and diluted weighted average common shares outstanding 61,433,124 $ 59,944,717 52,442,389

Kintara Therapeutics to Present Two Posters at the 2023 American Association for Cancer Research Annual Meeting

On March 15, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the Company will be presenting two posters at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place in Orlando, April 14-19 (Press release, Kintara Therapeutics, MAR 15, 2023, View Source [SID1234628786]). The presentation will include data from its lead program, VAL-083, for the treatment of recurrent glioblastoma.

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Data presentations:

Session Title: Late-Breaking Research: Clinical Research 1 / Endocrinology
Poster Section: 34
Presentation Time: Monday, April 17, 2023 – 1:30 to 5:00 p.m. ET

Title: RELA fusion-positive ependymoma and diffuse midline glioma treated with VAL-083 under expanded access – case reports
Abstract Number: LB126
Title: VAL-083 in patients with recurrent glioblastoma treated under expanded access program
Abstract Number: LB127
Abstracts are currently available on the AACR (Free AACR Whitepaper) website. A copy of the presentations will also be available after the closure of the meeting on April 19, under the Publications and Abstracts tab of the News & Media section of the Company’s website.