HOOKIPA Pharma Reports Second Quarter 2023 Financial Results and Recent Business Highlights

On August 10, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the second quarter of 2023 (Press release, Hookipa Biotech, AUG 10, 2023, View Source [SID1234634191]).

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"A key highlight was reporting our positive preliminary Phase 2 data on HB-200 in combination with pembrolizumab for advanced head and neck cancer. We continue to collect evidence that our novel arenaviral technology may help address unmet needs in cancer, with greater objective response rates than the current standard of care and clear trends towards duration of clinical benefit," said Joern Aldag, Chief Executive Officer at HOOKIPA Pharma. "We’re pleased investors also acknowledged the strength of our data with the $50 million capital raise. We’re now focused on preparing for the randomized trial of HB-200 in combination with pembrolizumab to start in the first half of 2024, as well as continuing to advance our clinical programs and diverse pipeline overall."

Quarter highlights

Oncology

In May, HOOKIPA announced positive preliminary Phase 2 data on HB-200 in combination with pembrolizumab in patients with recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head and neck cancers. Data from the ongoing study (NCT04180215) showed a 43 percent objective response rate with HB-200 in combination with pembrolizumab in checkpoint inhibitor (CPI)-naïve patients, doubling the response rate for pembrolizumab alone. HOOKIPA plans to share more data at a medical conference later this year and is preparing to start a randomized trial of HB-200 with pembrolizumab in the 1st-line setting in 2024.

In June, HOOKIPA presented a trial-in-progress presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on its ongoing Phase 1/2 study (NCT05553639) of HB-300 for the treatment of advanced prostate cancer. HB-300 is an arenaviral immunotherapy that targets two well-defined self-antigens of prostate cancer, prostatic acid phosphatase (PAP) and prostate-specific antigen (PSA). The ability to break immune tolerance and mount a strong T cell response against these self-antigens remains an unmet need in prostate cancer. Preclinical studies have demonstrated the ability of HOOKIPA’s arenaviral technology to break tolerance and elicit a strong immune response against self-antigens. Initial safety, tolerability and immunogenicity data from the ongoing Phase 1 study of HB-300 are expected in the first half of 2024.

HOOKIPA’s HB-700 program, in collaboration with Roche, is progressing to an expected Investigational New Drug (IND) application filing in the first half of 2024. HB-700 is a novel arenaviral immunotherapy for KRAS-mutated cancers, including lung, pancreatic and colon cancers.

Infectious disease

In May, HOOKIPA announced that the first participant had been dosed in a Gilead’s Phase 1 clinical trial (NCT05770895) of HB-400, an investigational therapeutic vaccine for chronic hepatitis B using HOOKIPA’s arenaviral platform. HB-400 is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences, Inc. Gilead is solely responsible for further development and commercialization of the hepatitis B product candidate.

HOOKIPA’s HB-500 program, partnered with Gilead, is progressing towards an anticipated IND filing in the second half of 2023 and is expected to commence a Phase 1 clinical trial in 2024. HB-500 is a novel arenaviral vaccine that will be assessed as part of a potential functional curative regimen for HIV.

Corporate

In June, HOOKIPA completed a $50 million public offering of common stock and non-voting convertible preferred stock. The net proceeds will support the randomized study of HB-200 in combination with pembrolizumab, as well as other clinical programs.

In August, the board of directors approved an exchange offer to eligible employees, excluding executive officers, members of the board of directors and members of HOOKIPA’s scientific advisory board, for certain underwater stock options. A total of 627,632 options with an exercise price per share greater than $6.50 will be eligible for exchange into up to a total of 315,505 new stock options with modified terms and an exercise price per share equal to the closing price on the grant date of the new option, but not less than $1.00. The exchange offer shall be made pursuant and subject to a tender offer statement, including an offer to exchange, to be filed with the Securities and Exchange Commission (SEC) today, which shall be the only basis for such offer.

Upcoming Milestones

Phase 2 HB-200 in HPV16+ head and neck cancers
1st-line follow-up data in combination with pembrolizumab: H1 2024
2nd+-line follow-up data in combination with pembrolizumab: Q1 2024
Start of 1st-line randomized study in combination with pembrolizumab:
H1 2024 (Fast Track designation)
Phase 1 HB-300 in prostate cancer
Preliminary safety and immunogenicity data: H1 2024
HB-700 in KRAS-mutated cancers: IND filing H1 2024
HB-400 in hepatitis B: to be determined by Gilead
HB-500 in HIV: IND filing 2023

Second Quarter 2023 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2023 was $136.0 million compared to $113.4 million as of December 31, 2022. The increase was primarily attributable to funds resulting from the follow-on financing in June 2023, partly offset by cash used in operating activities.

Revenue: Revenue was $2.7 million for the three months ended June 30, 2023 and for the three months ended June 30, 2022. A decrease of cost reimbursements received under the Restated Gilead Collaboration Agreement, was largely offset by higher partial recognition of the upfront and milestone payments under the Gilead collaboration and Roche collaboration.

Research and Development Expenses: HOOKIPA’s research and development expenses were $19.7 million for the three months ended June 30, 2023, compared to $16.1 million for the three months ended June 30, 2022. The primary drivers of the increase in research and development expenses by $3.6 million compared to the three months ended June 30, 2022 were higher clinical study expenses for our HB-200 and HB-300 programs as well as increased spending for our Gilead and Roche partnered programs.

General and Administrative Expenses: General and administrative expenses amounted to $4.4 million for the three months ended June 30, 2023, compared to $5.0 million for the three months ended June 30, 2022. The decrease was primarily due to a decrease in other expenses, and a decrease in personnel-related expenses, partially offset by an increase in professional and consulting fees. The decrease in personnel-related expenses resulted from decreased stock compensation expenses, partially offset by a growth in headcount along with increased salaries in our general and administrative functions as well as expenses for contractors.

Net Loss: HOOKIPA’s net loss was $18.0 million for the three months ended June 30, 2023, compared to a net loss of $16.4 million for the three months ended June 30, 2022. This increase was primarily due to an increase in research and development expenses.

Genprex Granted FDA Orphan Drug Designation (ODD) for REQORSA® Immunogene Therapy for the Treatment of Small Cell Lung Cancer

On August 10, 2023 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the Company’s lead drug candidate, REQORSA Immunogene Therapy (quratusugene ozeplasmid), for the treatment of small cell lung cancer (SCLC) (Press release, Genprex, AUG 10, 2023, View Source [SID1234634190]).

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In addition to ODD for the treatment of SCLC, in June 2023, the FDA granted Fast Track Designation (FTD) for REQORSA Immunogene Therapy, in combination with Genentech, Inc’s Tecentriq in patients with extensive-stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. With ES-SCLC, the cancer has spread from one lung to the other, or to other parts of the body. Extensive-stage is the most common type of SCLC. FDA has also granted Genprex FTD for two other indications of REQORSA Immunogene Therapy, including REQORSA in combination with Tagrisso for non-small cell lung cancer (NSCLC) in patients who have progressed after Tagrisso treatment, and REQORSA in combination with Keytruda for NSCLC in patients who have progressed after Keytruda treatment.

"We are excited to receive Orphan Drug Designation from the FDA for REQORSA for patients with SCLC," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex. "This FDA Orphan Drug Designation in combination with our recently received FDA Fast Track designation underscores the great need for better treatment options for patients with SCLC, ES-SCLC and NSCLC. We look forward to initiating the Acclaim-3 clinical trial expected in the fourth quarter of 2023 in order to bring hope of an effective new therapy to patients suffering with this life-limiting cancer."

The FDA grants ODD status to investigational therapies being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. Further, ODD provides benefits to drug developers, including assistance in the drug development process, tax credits for qualified trials, waiver of certain FDA fees, and potential for seven years of post-approval marketing exclusivity.

Genprex’s method of treating cancer is to reexpress tumor suppressor genes in cancers. Tumor suppressor genes are deleted or inactivated early in the process of cancer development. REQORSA contains a plasmid that expresses a tumor suppressor gene protein called TUSC2. Virtually 100% of small cell lung cancers have reduced or no TUSC2 protein expression, and 41% completely lack TUSC2 protein expression. Pre-clinical studies in mice suggest that re-expressing the TUSC2 protein may lead to clinical efficacy. ES-SCLC has a very poor prognosis, with a median progression free survival (PFS) of only 5.2 months. Importantly, median PFS for patients receiving Tecentriq as maintenance therapy is only 2.6 months from the start of maintenance treatment, so there is a great need for improvement in maintenance therapy.

About Acclaim-3 Clinical Trial

The Acclaim-3 clinical trial is a Phase 1/2 open-label, dose escalation and clinical response study of maintenance therapy evaluating REQORSA in combination with Tecentriq in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.

Patients in the Acclaim-3 clinical trial will be enrolled after receiving initial treatment with 3-4 cycles of carboplatin, etoposide, and Tecentriq, and achieving complete response, partial response or stable disease. They will then receive treatment with REQORSA and Tecentriq as maintenance therapy every 21 days until disease progression.

The Phase 1 dose escalation portion of the Acclaim-3 clinical trial is expected to enroll up to 12 patients at 3-5 U.S. clinical sites to determine the Maximum Tolerated Dose (MTD). If no dose limiting toxicities occur during Phase 1, then the highest dose evaluated will be the Recommended Phase 2 Dose. The Phase 2 portion of the study will then enroll approximately 50 patients at 5-10 sites. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.

The primary endpoint of the Phase 2 portion of the trial is to determine the 18-week progression-free survival rate from the time of the start of maintenance therapy with REQORSA and Tecentriq in patients with ES-SCLC. Patients will also be followed for survival. A Phase 2 futility analysis will be performed after the 25th patient enrolled and treated reaches 18 weeks of follow up.

Exscientia Business Update for Second Quarter and First Half of 2023

On August 10, 2023 Exscientia plc (Nasdaq: EXAI) reported that Recent advancements in the Company’s pipeline, collaborations and operations, as well as financial results for the second quarter and first half 2023, are summarised below (Press release, Exscientia, AUG 10, 2023, View Source [SID1234634189]). Exscientia will host a conference call Thursday, August 10 at 1:30 p.m. BST / 8:30 a.m. EDT.

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"In the first half of 2023, four molecules precision-designed by Exscientia advanced further into clinical trials, a significant achievement as we progress our growing pipeline," said Professor Andrew Hopkins FRS FMedSci, founder and Chief Executive Officer of Exscientia. "Most recently, we announced the dosing of the first patient in ELUCIDATE, a Phase 1/2 trial of our CDK7 inhibitor GTAEXS617 (‘617). We also initiated a prospective observational study, EXCYTE-1, evaluating the utility of our precision medicine platform in ovarian cancer, paving the way for its potential broader application across solid tumours. As we continue executing our internal and partnered programmes and integrating automation across our end-to-end discovery process, Exscientia is solidifying its leadership in AI-enabled drug design and development."

Recent Highlights

Internal pipeline
●In July, Exscientia announced enrolment of the first patient in ELUCIDATE, a Phase 1/2 dose escalation trial evaluating its novel CDK7 inhibitor, ‘617, for the treatment of advanced solid tumours
○‘617 was designed by Exscientia in collaboration with GT Apeiron for high potency, selectivity, oral bioavailability and safety
○The ELUCIDATE Phase 1/2 trial will evaluate the safety, efficacy and pharmacokinetics of ‘617 across multiple ascending doses in six indications including head and neck cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast carcinoma and ovarian cancer
●EXS21546 (‘546), Exscientia’s A2AR antagonist, continues to enrol patients in the Phase 1/2 IGNITE clinical trial in relapsed/refractory renal cell carcinoma and NSCLC
●EXS74539 (‘539) and EXS73565 (‘565), Exscientia’s wholly-owned LSD1 inhibitor and MALT1 protease inhibitor, respectively, continue to progress through IND/CTA-enabling studies

Partnered programmes
●Two programmes, EXS4318 (‘4318) a PKC-theta inhibitor precision designed by Exscientia and in-licensed by Bristol-Myers Squibb, and DSP-2342, a dual 5-HT2A/5-HT7 antagonist designed for Sumitomo Pharma, are now in Phase 1 clinical trials

Precision medicine
●In July, Exscientia announced the initiation of EXCYTE-1, a prospective observational study to evaluate the utility of Exscientia’s precision medicine platform in ovarian cancer
○The multi-centre two-phase study will evaluate Exscientia’s single cell functional precision medicine platform in ovarian cancer and investigate the relationship between ex vivo drug response in primary tumour samples and patient clinical response
○The study also aims to further validate the platform for wider use across a variety of solid tumours

AI and automation
●Exscientia opened its automation laboratory in Milton Park, Oxfordshire, which will enable the Company to integrate generative AI and automation to drive faster, high quality experimentation
●The Company is building its own hardware and software solutions to automate a wide range of experimental laboratory processes including chemical synthesis, as well as biochemical and biophysical screening
●Capabilities are expected to be online later in 2023

Leadership expansion and recognition
●The Company expanded its technology leadership team to maintain nimble product development through the promotion of three experienced leaders to Exscientia’s executive committee. Each heads one of three newly created technology functions to further align executive decision-making with Exscientia’s functional priorities in technology:

oProfessor Charlotte Deane, Ph.D. MBE has been promoted to Chief AI Officer, with continued focus on the application of AI, machine learning and physics-based methods for the discovery and development of novel drug candidates
oEileen Jennings-Brown joined Exscientia as Chief Information Officer in 2022 and will continue to be responsible for this critical priority going forward
oJohn P. Overington, Ph.D. has been promoted to Chief Data Officer, focused on leading a unified data function covering all aspects of data generation and analysis
●Exscientia also appointed Harvard Professor Franziska Michor, Ph.D., to its Board of Directors. Professor Michor brings over 20 years of experience in cancer research and has authored more than 180 publications. Her work currently focuses on the evolutionary dynamics of cancer initiation, progression, response to therapy and emergence of resistance

Investor Call and Webcast Information
Exscientia will host a conference call on Thursday, August 10 at 1:30 p.m. BST / 8:30 a.m. EDT.
A webcast of the live call can be accessed by visiting the "Investors and Media" section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialling +1 (888) 330 3292 (U.S.), +44 203 433 3846 (U.K.), +1 (646) 960 0857 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.

Second Quarter and First Half 2023 Financial Results
For the convenience of the reader, the Company has translated pound sterling amounts to U.S. dollars at the rate of £1.000 to $1.2709, which was the noon buying rate of the Federal Reserve Bank of New York on June 30, 2023.

Revenue: Revenue for the three and six months ended June 30, 2023 was $3.8 million and $11.1 million respectively, compared to $9.1 million and $17.9 million for the three and six months ended June 30, 2022. The decrease in revenue year over year was primarily due to amounts recognised in the prior period relating to a collaboration term extension payment.

Research and development expenses: R&D expenses for the three and six months ended June 30, 2023 were $42.0 million and $84.4 million respectively, as compared to $42.0 million and $71.8 million for the same period ended June 30, 2022. Research and development expenses in the second quarter 2023 were relatively flat over the second quarter 2022, as areas of pipeline and operational growth were offset by efficiency and cost savings activities.

General and administrative expenses: G&A expenses for the three and six months ended June 30, 2023, were $14.7 million and $28.6 million respectively, or 23% and 22% of total operating expenses. For the three and six months ended June 30, 2023, G&A expenses decreased by $0.6 million and increased by $3.3 million compared to the three and six months ended June 30, 2022 respectively, primarily associated with the growth of the business being offset by automation and cost efficiency measures.

Cash inflows: For the second quarter 2023, Exscientia received $0.7 million in cash inflows from its collaborations as compared to $111.0 million during the second quarter 2022, when the upfront payment for the Sanofi collaboration was received.

Net operating cash flow and cash balance: For the three and six months ended June 30, 2023, net operating cash outflows were $52.5 million and $107.6 million respectively, in comparison to net operating cash inflows of $54.9 million and $35.0 million for the three and six months ended June 30, 2022. Cash, cash equivalents and short-term bank deposits as of June 30, 2023 were $508.6 million, as compared to $642.8 million as of December 31, 2022 using the June 30, 2023 constant currency rate.
●Includes constant currency mark-to-market foreign exchange impact of 5% based on the strengthening of pounds sterling through June 30, 2023
●During the second quarter of 2023, Exscientia recognised net foreign exchange losses of $0.5 million
●The Company holds its deposits in both GBP and USD, intended to match expected operational cash needs in order to limit the impact of exchange rate fluctuations

Erasca Reports Second Quarter 2023 Financial Results and Business Updates

On August 10, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported financial results for the fiscal quarter ended June 30, 2023, and provided business updates (Press release, Erasca, AUG 10, 2023, View Source [SID1234634188]).

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"Our team continues to achieve important milestones for our four clinical programs that underscore their potential to address unmet needs for multiple patient segments affected by oncogenic RAS/MAPK pathway signaling," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Expansion of ERAS-007 plus encorafenib and cetuximab (EC) in patients with EC-naïve BRAF-mutated (BRAFm) colorectal cancer (CRC) is advancing following the encouraging early efficacy data seen in HERKULES-3 [50% (3/6) response rate (2 cPR, 1 uPR) at the highest dose tested]. We are also building on the encouraging initial Phase 1b dose escalation data for ERAS-601 plus cetuximab in FLAGSHP-1, with Phase 1b combination dose expansion data planned for the first half of 2024."

Dr. Lim continued, "Importantly, we remain on track to dose the first patient in the SEACRAFT-1 Phase 1b trial in RAS Q61X solid tumors for our most advanced program, the potential first-in-class and best-in-class pan-RAF inhibitor naporafenib. Finally, we are continuing to advance our CNS-penetrant EGFR inhibitor ERAS-801, which was granted FDA Fast Track and Orphan Drug Designations, in recurrent glioblastoma (GBM). Our balance sheet continues to be strong, supporting a cash runway into the second half of 2025 and through the execution of meaningful clinical catalysts over the next 18 months."

Research and Development (R&D) Highlights


Presented Promising HERKULES-3 Phase 1b Data and Refined Pipeline: In June 2023, Erasca presented preliminary Phase 1b data for ERAS-007 in combination with encorafenib + cetuximab (EC) in patients with BRAFm CRC, showing a 50% (3/6) response rate (2 confirmed partial responses, 1 unconfirmed partial response), reinforcing ERAS-007 as a potential best-in-class ERK inhibitor. In addition, a strategic pipeline prioritization sharpened Erasca’s focus on existing programs with the highest probability of success.

Granted FDA Orphan Drug and Fast Track Designations for ERAS-801: In June 2023, Erasca announced that the United States Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to ERAS-801 (CNS-penetrant EGFR inhibitor) for the treatment of malignant glioma, which includes GBM. In May 2023, Erasca announced that the FDA granted Fast Track Designation (FTD) to ERAS-801 for the treatment of adult patients with GBM with EGFR gene alterations.

Presented Promising FLAGSHP-1 Phase 1b Data: In April 2023, Erasca presented promising data for ERAS-601 (SHP2 inhibitor) in combination with cetuximab in patients with advanced solid tumors as part of a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Announced Publication of Phase 1b Data for Naporafenib: In April 2023, Erasca announced the publication of results in the Journal of Clinical Oncology from the expansion arm of a Phase 1b open label trial evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib (MEKINIST) in patients with NRASm melanoma. This potential will be further explored in our SEACRAFT-2 pivotal Phase 3 trial.

Corporate Highlights


Appointed Lead Independent Director: In July 2023, James Bristol, Ph.D., was appointed to the position of lead independent director. In addition to this role, Dr. Bristol shall continue to serve on the board’s compensation committee and nominating and corporate governance committee.

Strengthened Business Leadership: In May 2023, Erasca promoted David Chacko, M.D., previously Erasca’s chief financial officer, to the dual position of chief financial officer and chief business officer, and Nik Chetwyn, Ph.D., previously Erasca’s senior vice president of operations, to chief operating officer.

Key Upcoming Milestones


SEACRAFT-1: Phase 1b trial for naporafenib plus trametinib in patients with RAS Q61X tissue agnostic solid tumors
o
Dosing of the first patient expected in the second half of 2023
o
Initial Phase 1b combination data expected between the second and fourth quarters of 2024

SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib plus trametinib in patients with NRASm melanoma
o
Dosing of the first patient expected in the first half of 2024

HERKULES-3: Phase 1b trial for ERAS-007 plus EC in EC-naïve patients with BRAFm CRC
o
Phase 1b combination expansion data in patients with BRAFm CRC expected between the second half of 2023 and the first half of 2024

FLAGSHP-1: Phase 1b trial for ERAS-601 in patients with advanced solid tumors
o
Phase 1b combination expansion data in relevant patient populations, including patients with human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC), expected in the first half of 2024

THUNDERBBOLT-1: Phase 1 trial for ERAS-801 in patients with recurrent GBM
o
Initial Phase 1 monotherapy dose escalation data in patients with recurrent GBM expected in the second half of 2023

Second Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $365.3 million as of June 30, 2023, compared to $435.6 million as of December 31, 2022. Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $26.2 million for the quarter ended June 30, 2023, compared to $27.5 million for the quarter ended June 30, 2022. The decrease was

primarily driven by decreases in expenses incurred in connection with clinical trials, preclinical studies, discovery activities and outsourced services and consulting fees, partially offset by increases in facilities-related expenses and depreciation, and personnel costs, including stock-based compensation.

General and Administrative (G&A) Expenses: G&A expenses were $9.8 million for the quarter ended June 30, 2023, compared to $8.4 million for the quarter ended June 30, 2022. The increase was primarily driven by personnel costs, including stock-based compensation expense.

Net Loss: Net loss was $31.8 million, or $(0.21) per basic and diluted share, for the quarter ended June 30, 2023, compared to $35.6 million, or $(0.30) per basic and diluted share, for the quarter ended June 30, 2022.

CytomX Therapeutics to Present at the H.C. Wainwright Immune Cell Engager Virtual Conference

On August 10, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will present at the H.C. Wainwright Immune Cell Engager Virtual Conference on Thursday, August 17 at 9:00 a.m. ET (Press release, CytomX Therapeutics, AUG 10, 2023, View Source [SID1234634186]).

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A live webcast of the fireside chat will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.