On May 10, 2023 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a leading T-cell receptor (TCR) cell therapy company advancing a clinical-stage pipeline of therapeutics for solid tumors, reported financial results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Alaunos Therapeutics, MAY 10, 2023, View Source [SID1234631408]).

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"Our TCR-T Library Phase 1/2 trial continues to garner significant interest among patients, physicians and investigators," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We’ve been actively enrolling patients and manufacturing cryopreserved products, and we expect to report interim clinical data in the third quarter of this year. As we work to fully realize the long-term potential of our TCR-T platform, we have simplified our corporate structure with the full prepayment of our loan with SVB and the recent agreement with Precigen. We are now moving forward unencumbered by debt or these potential royalties as we seek to transform the treatment of solid tumors."

Recent Developments and Upcoming Milestones

TCR-T Library Phase 1/2 trial actively enrolling patients: Alaunos continues to actively enroll patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53 and EGFR driver mutations across six solid tumor indications. Early translational data from the first three patients treated in the program will be highlighted in a poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023. Alaunos currently expects to provide an interim data update on multiple new patients in the third quarter of this year as the Company advances the program towards Phase 2 readiness with a recommended Phase 2 dose anticipated by year end 2023.

Manufactured multiple cryopreserved products: In the first quarter of 2023, Alaunos enhanced its manufacturing process to move from fresh to cryopreserved cell product enabling greater flexibility for patient scheduling and treatment. To date, the Company has manufactured multiple cryopreserved products with viability, purity and TCR positivity comparable to our prior process.

Completed full prepayment of amended loan and security agreement with Silicon Valley Bank (SVB): In May 2023, Alaunos fully prepaid the remaining amounts owed under its term loan with SVB, which was $11.0 million as of March 31, 2023. With no remaining obligations due to SVB, the restricted cash balance of $13.9 million as of March 31, 2023, has also been released.

Amended exclusive license agreement with Precigen, Inc.; Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations: In April 2023, Alaunos amended its exclusive license agreement with Precigen. Under the terms of the amended agreement, Alaunos maintains exclusive rights to TCRs using Sleeping Beauty targeting driver mutations, while Precigen regains the rights to its CAR-T and IL-12 assets. The amended agreement eliminated all commercial sales-based royalties and milestone obligations, in alignment with Alaunos’ focus on its priority TCR-T programs.

Expanded infrastructure of hunTR TCR discovery platform to increase throughput; expect to add three new TCRs in 2023: In the first quarter of 2023, Alaunos significantly increased the throughput potential of its hunTR TCR discovery platform to further accelerate TCR discovery and validation. New lab equipment and advanced bioinformatics capabilities have multiplied the screening throughput while maintaining a high success rate of TCR discovery. The Company expects to add three new TCRs to its library, potentially bringing the total number of unique TCRs to 15 by the end of 2023.

Appointed Robert Hofmeister, PhD, MS, to Board of Directors: In March 2023, Alaunos appointed Robert J. Hofmeister, PhD, MS, to the Company’s board of directors. Dr. Hofmeister brings deep expertise in the discovery and development of engineered T-cell receptor therapies as well as a background in cellular immunology and translational science. He is currently Chief Scientific Officer of a stealth early-stage biotechnology company and was most recently Chief Scientific Officer at TCR2 Therapeutics.

First Quarter Ended March 31, 2023, Financial Results

Research and Development Expenses: Research and development expenses were $6.5 million for the first quarter of 2023, compared to $5.6 million for the first quarter of 2022, an increase of approximately 17%. The increase was primarily due to incremental manufacturing activities related to the TCR-T Library Phase 1/2 trial and hunTR research efforts of $1.7 million, partially offset by a $0.7 million decrease in employee-related expenses.

General and Administrative Expenses: General and administrative expenses were $3.2 million for the first quarter of 2023, compared to $3.5 million for the first quarter of 2022, a decrease of approximately 10%. The decrease was primarily due to lower professional fees of $0.2 million.

Net Loss: Net loss was $10.0 million, or $(0.04) per share, for the first quarter of 2023, compared to a net loss of $9.8 million, or $(0.05) per share, for the first quarter of 2022.

Cash, Cash Equivalents and Restricted Cash: As of March 31, 2023, Alaunos had approximately $37.4 million in cash balances, which included restricted cash of approximately $13.9 million. Based on current operating plans, the Company expects its operating outflows, excluding debt service costs, for 2023 to be between approximately $35 million and $40 million. The Company expects to have sufficient cash resources to fund research and development programs and operations into the fourth quarter of 2023.

Conference Call and Webcast

Alaunos will host a conference call and webcast today, May 10, 2023, at 9:00 a.m. ET. Participants may access the live webcast using the link here or by visiting the "Investors" section of the Alaunos website at www.alaunos.com. 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 event will be archived on the Company’s website for approximately 30 days after the call.

On May 10, 2023 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the quarter ended March 31, 2023, and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAY 10, 2023, View Source [SID1234631407]).

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"We believe that azenosertib has the potential to benefit large numbers of patients who are facing difficult-to-treat cancers. As a result, our highest priority remains the successful execution of our development strategy for this promising therapeutic," said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "We began the year by initiating enrollment in our Pfizer-partnered clinical trial combining azenosertib with the BEACON regimen in BRAF V600E mutant metastatic colorectal cancer. At AACR (Free AACR Whitepaper) in April, we presented preclinical data supporting the use of CCNE1 amplification and/or Cyclin E1 expression as a potential marker for the enrichment of patient populations for treatment with azenosertib. We are driving toward two additional milestones for azenosertib in the first half of the year – disclosing our monotherapy dose, and sharing positive clinical data from our chemotherapy combination trial in ovarian cancer at ASCO (Free ASCO Whitepaper) in June."

The Company also announced the appointment of Diana Hausman, M.D., to the Board of Directors. "I share Zentalis’ passion and commitment to developing therapeutics for difficult-to-treat cancers," said Dr. Hausman. "I believe azenosertib has the potential to be a game-changing therapeutic for cancer patients, and I look forward to working with the other members of the Board and the Zentalis management team to help the Company achieve its goals."

WEE1 Inhibitor (Azenosertib) Program Highlights

•On track to announce monotherapy dose in first half 2023. The Company is optimizing monotherapy dosing across the azenosertib program with the goal of maximizing exposure and tolerability, as well as enabling the potential clinical benefits of the agent to reach the broadest range of patients. The Company remains on track to provide an update on azenosertib monotherapy dosing in the first half of 2023.

•Company to present positive chemotherapy combination data at 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. The Company will present results from its Phase 1b chemotherapy combination trial in ovarian cancer, which will include Cyclin E1 translational data, at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting in Chicago, on June 5, 2023.

•Preclinical support for Cyclin E1 as a predictive marker presented at AACR (Free AACR Whitepaper). Zentalis identified high Cyclin E1 protein expression and/or CCNE1 gene amplification in high-grade serous ovarian cancer as a patient enrichment strategy for azenosertib, which is currently enrolling its Phase 2 clinical study in high-grade serous ovarian cancer. In April, the Company presented preclinical data supporting the rationale for the Cyclin E1 enrichment strategy at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023.

•Initiated mCRC study in collaboration with Pfizer. As previously disclosed, in the first quarter of 2023, Zentalis initiated enrollment for its Phase 1/2 dose escalation study of azenosertib in combination with encorafenib and cetuximab (BEACON regimen) in BRAF V600E mutant metastatic colorectal cancer (mCRC) patients. Zentalis is collaborating with Pfizer Inc. on this study.

•Collaborations with Foundation Medicine and Roche Diagnostics. In April, the Company announced separate agreements with Foundation Medicine, Inc., an independent affiliate of the Roche Group, and with Roche Diagnostics. The current Foundation Medicine partnership involves global prospective genomic profiling for potential patient enrollment in Zentalis’ Phase 2 clinical trial of azenosertib in Cyclin E1 driven high-grade serous ovarian cancer. The Roche Diagnostics agreement is focused on the development of an immunohistochemistry-based clinical trial assay that evaluates Cyclin E1 protein levels and that can potentially identify a broader patient population with high protein expression in the absence of amplification.

BCL-2 Inhibitor (ZN-d5) 2023 Milestones

•Amyloidosis study. As previously communicated, Zentalis plans to announce interim clinical data and disclose the dose for the Phase 1/2 monotherapy clinical trial of ZN-d5 in relapsed or refractory light chain (AL) amyloidosis in the second half of 2023.

•AML study. The Company has initiated a Phase 1/2 combination study of ZN-d5 and azenosertib in relapsed or refractory acute myeloid leukemia (AML) and, as previously disclosed, expects to provide preliminary data from the trial in the second half of 2023.

Corporate Highlights

•In May 2023, the Company appointed Diana Hausman, M.D., to its Board of Directors. Dr. Hausman is an oncologist with extensive experience in all aspects of drug development, including development and implementation of clinical strategy. Dr. Hausman is currently serving as Chief Medical Officer of Link Immunotherapeutics. Dr. Hausman previously served as Chief Medical Officer of Lengo Therapeutics, Zymeworks and Oncothyreon. Prior to Oncothyreon, Dr. Hausman held positions of increasing responsibility at ZymoGenetics, Berlex Laboratories and Immunex. Dr. Hausman currently serves on the Board of Directors of Immuneering.

•In February 2023, the Company appointed Funda Meric-Bernstam, M.D., a widely recognized Phase 1 trial expert and experimental therapeutics researcher in oncology, to its Scientific Advisory Board. Dr. Meric-Bernstam is the Chair of the Department of Investigational Cancer Therapeutics — the Phase 1 Program at The University of Texas MD Anderson Cancer Center.

Her clinical research is focused on novel therapeutics, novel combination therapies and biomarkers to predict and monitor drug response.

First Quarter 2023 Financial Results

•Cash and Marketable Securities Position: As of March 31, 2023, Zentalis had cash, cash equivalents and marketable securities of $392 million. The Company believes that its existing cash, cash equivalents and marketable securities as of March 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

•Research and Development Expenses: Research and Development Expenses: Research and development (R&D) expenses for the quarter ended March 31, 2023 were $48.6 million, compared to $46.1 million for the three months ended March 31, 2022. The increase of $2.5 million was primarily due to a $3.2 million increase in overhead allocations driven by an operating lease impairment charge, and an increase of $1.9 million in personnel costs. These increases were partially offset by a $1.8 million decrease in clinical trial-related costs and $0.8 million in decreased collaborative costs.

•General and Administrative Expenses: General and administrative (G&A) expenses for the quarter ended March 31, 2023 were $16.4 million, compared to $11.8 million during the three months ended March 31, 2022. This increase of $4.6 million was primarily attributable to a $5.0 million operating lease impairment charge and a $3.0 million increase in personnel costs, of which $2.7 million was non-cash stock-based compensation. These increases were partially offset by $3.1 million related to the allocation of overhead expenditures, and net reductions in outside services and supplies of $0.3 million.

About Azenosertib

Zentalis’ azenosertib (ZN-c3) has been designed to be a highly potent and selective WEE1 inhibitor.
Azenosertib is currently being evaluated in the clinic for advanced solid tumors and hematological malignancies in the following three therapeutic settings of high unmet medical need: (1) as a monotherapy, (2) in combination with traditional chemotherapy and DNA damaging agents, and (3) in combination with molecularly targeted agents. As a monotherapy, azenosertib is currently being evaluated in a Phase 2 clinical trial in adult women with uterine serous carcinoma (USC), an aggressive form of endometrial cancer that accounts for approximately 10-15% of all endometrial cancers. We are also evaluating azenosertib as a monotherapy in a Phase 2 clinical trial in patients with Cyclin E1 driven high-grade serous ovarian cancer (HGSOC). The Company is evaluating azenosertib as a monotherapy in a Phase 1 dose optimization clinical trial in patients with advanced solid tumors, and plans to disclose the monotherapy dose and provide an update on dose optimization activities in the first half of 2023. In chemotherapy combinations, azenosertib is currently being evaluated in combination with each of paclitaxel, carboplatin, pegylated liposomal doxorubicin (PLD) and gemcitabine in four cohorts in a Phase 1b clinical trial in patients with advanced platinum-resistant ovarian, peritoneal or fallopian tube cancer. The Company plans to disclose results from this study in the first half of 2023, in advance of original guidance. Azenosertib is also currently being evaluated in combination with gemcitabine in a Phase 1/2 clinical trial in adult and pediatric patients with relapsed or refractory osteosarcoma. In combination with molecularly targeted agents, the Company is studying azenosertib in combination with GlaxoSmithKline plc’s (GSK’s) PARP inhibitor, niraparib (ZEJULA), in a Phase 1/2 clinical trial in platinum-resistant ovarian cancer patients who have failed PARP inhibitor maintenance treatment as part of a clinical collaboration with GSK. The Company is also collaborating with Pfizer Inc. to evaluate azenosertib in combination with encorafenib and cetuximab, an FDA-approved standard of care known as the BEACON regimen, in patients with BRAF V600E mutant metastatic colorectal cancer in a Phase 1/2 clinical trial.

On May 10, 2023 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported its financial results and a business update for the first quarter ended March 31, 2023 (Press release, VolitionRX, MAY 10, 2023, View Source [SID1234631406]). Volition management will host a conference call tomorrow, May 11 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

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"It has been a phenomenal start to the year, with the launch of our Nu.Q Vet Cancer Test through IDEXX’s reference laboratory network. It is also available as the Heska Nu.Q Canine Cancer Screen and Monitor test through Heska’s veterinary diagnostic laboratory and for pre-order at the point of care. Without a doubt, establishing global supply agreements with two global industry leaders offers what we expect to be significant revenue opportunities for Volition, and we are delighted to report a 381% increase in sales to $124,000 of the Nu.Q Vet Cancer Test for the first quarter compared to the previous year.

"Our goal is to make canine cancer screening and monitoring accessible worldwide and we are moving ever closer to realizing our mission as we are expecting launches in additional countries this year," commented Cameron Reynolds, President and Group Chief Executive Officer of Volition.

"We also continued to work diligently in our efforts to bring Nu.Q NETs to market, and we are now undertaking large-scale finding studies across multiple sites in the U.S. to determine clinical utility in sepsis and support an application to the FDA’s Breakthrough Device Program. We believe that the Nu.Q NETs test is a ground-breaking diagnostic aid that clinicians can use to detect the diseases associated with NETosis and anticipate that this will be a pivotal year as we progress towards commercialization."

Volition is hosting a Capital Markets Day at the New York Stock Exchange, in a hybrid format, tomorrow, Thursday May 11, at 2:00 p.m. U.S. Eastern Time. Volition’s executive team will provide strategic updates on both Nu.Q NETs and Nu.Q Vet and will be joined by Key Opinion Leaders: Dr. Andy Retter (Intensive Care Consultant); Veterinary Oncologists, Professor Heather Wilson-Robles and Dr. Sue Ettinger. Details for this event can be found below.

Financial Highlights

·

Cash and cash equivalents as of March 31, 2023, totaled approximately $10 million compared with $10.9 million at the end of 2022.

·

Received approximately $8 million net of underwriter’s fees and commissions in cash through an underwritten public offering of its common stock in February.

·

Expect to receive a further $13 million in milestone payments from Heska Corporation and additional funding, including non-dilutive funding, from three Belgian agencies, in the coming months.

Event: VolitionRx Limited First Quarter 2023 Earnings and Business Update Conference Call

Date: Thursday, May 11, 2023

Time: 08:30 a.m. U.S. Eastern Time

U.S. & Canada Dial-in: 1-877-407-9716 (toll free)

U.K. Dial-in: 0 800 756 3429 (toll free)

Toll/International: 1-201-493-6779

Conference ID: 13738662

Cameron Reynolds, President and Group Chief Executive Officer of Volition, will host the call along with Terig Hughes, Group Chief Financial Officer, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on important events which have taken place in the first quarter of 2023 and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 25, 2023. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13738662.

On May 10, 2023 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the first quarter ended March 31, 2023, and provided updated full-year 2023 financial guidance (Press release, Vericel, MAY 10, 2023, View Source [SID1234631405]).

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First Quarter 2023 Financial Highlights

•Total net revenue of $41.0 million
•MACI net revenue of $34.2 million and Epicel net revenue of $6.8 million
•Gross margin of 65%
•Net loss of $7.5 million, or $0.16 per diluted share
•Non-GAAP adjusted EBITDA of $1.7 million
•Operating cash flow of $7.9 million
•As of March 31, 2023, the Company had approximately $139 million in cash and investments, and no debt

Business Highlights and Updates
•Record first quarter total revenue
•Highest first quarter MACI revenue since launch, representing growth of 32% compared to the prior year
•Highest number of surgeons taking MACI biopsies and second highest number of MACI biopsies in a quarter since launch
•11th straight quarter of positive adjusted EBITDA and operating cash flow
•MACI arthroscopic delivery program remains on track for an anticipated 2024 commercial launch
•Tracking ahead of initial goals on NexoBrid Pharmacy and Therapeutics (P&T) committee submissions and approvals at target burn centers
1
Exhibit 99.1
•NexoBrid selected for inclusion in the pre-conference healthcare professional educational sessions at the upcoming American Burn Association (ABA) annual meeting with hands-on lab demonstrations by leading burn surgeons
"The Company had a very strong start to the year, delivering record quarterly MACI and total revenue and another quarter of profitability and operating cash flow," said Nick Colangelo, President and CEO of Vericel. "MACI has continued on its high-growth trajectory with first quarter revenue growth of more than 30% and, based on our positive first quarter performance and strong underlying business fundamentals, we have increased our 2023 full-year revenue guidance. We look forward to the upcoming commercial launch of NexoBrid and continue to advance the MACI arthroscopic delivery program, which we believe will drive further growth in the years ahead."

2023 Financial Guidance
•Total net revenue for 2023 now expected to be in the range of $184 to $192 million compared to the previous guidance of $180 to $188 million
•Maintaining profitability guidance of gross margin in the high-60% range and adjusted EBITDA margin in the mid-teens % range
First Quarter 2023 Results
Total net revenue for the quarter ended March 31, 2023 increased 14% to $41.0 million, compared to $36.1 million in the first quarter of 2022. Total net product revenue for the quarter included $34.2 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $6.8 million of Epicel (cultured epidermal autografts) net revenue, compared to $26.0 million of MACI net revenue and $9.9 million of Epicel net revenue, respectively, in the first quarter of 2022.
Gross profit for the quarter ended March 31, 2023 was $26.5 million, or 65% of net revenue, compared to $23.5 million, or 65% of net revenue, for the first quarter of 2022.
Total operating expenses for the quarter ended March 31, 2023 were $34.7 million, compared to $30.7 million for the same period in 2022. The increase in operating expenses was primarily due to an increase in employee-related expenses and higher sales and marketing expenses.
Net loss for the quarter ended March 31, 2023 was $7.5 million, or $0.16 per diluted share, compared to $7.1 million, or $0.15 per diluted share, for the first quarter of 2022.
Non-GAAP adjusted EBITDA for the quarter ended March 31, 2023 was $1.7 million, or 4% of net revenue, compared to $3.2 million, or 9% of net revenue, for the first quarter of 2022. A table reconciling non-GAAP measures is included in this press release for reference.

Exhibit 99.1
As of March 31, 2023, the Company had approximately $139 million in cash and investments, and no debt.
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate by telephone, please register here to receive dial-in details and your personal passcode. A replay of the webcast will be available on the Vericel website until March 31, 2024.

On May 10, 2023 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the first quarter ended March 31, 2023 (Press release, Tracon Pharmaceuticals, MAY 10, 2023, View Source [SID1234631404]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We were pleased with the arbitration award of approximately $23 million, which will extend our cash runway into early 2024, when collected," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Most importantly, in the third quarter we expect the second and final interim efficacy analysis in the ongoing ENVASARC pivotal trial that will review 46 patients in the cohort of single agent envafolimab and 46 patients in the cohort of envafolimab dosed with Yervoy (ipilimumab), after each patient has had two on-study scans. Accrual in ENVASARC remains ahead of projections and we expect to complete enrollment before year end, with final data anticipated in mid-2024 and potential commercial launch in 2025."

Recent Corporate Highlights

In March, we announced a private placement of approximately $3.0 million with an accredited institutional healthcare-focused fund, which was completed at market price.
In April, we announced we received an arbitration award of approximately $23.0 million from the arbitration with I-Mab Biopharma.
In May, we entered into a Common Stock Purchase Agreement with Lincoln Park Capital Fund, LLC ("LPC"), in which LPC has committed to purchase up to $26.0 million of shares of our common stock from time to time at prices based on the market price calculated over a certain period of time and in accordance with terms set forth in the Common Stock Purchase Agreement. Additionally, LPC has committed to purchase upon our request up to $1.0 million of shares of our common stock when all conditions to commencement are met, including that a resale registration statement is filed and declared effective.
Expected Upcoming Milestones

Report an ad hoc analysis from the ENVASARC pivotal trial by the independent data monitoring committee (IDMC) as required by the IDMC Charter that requires a review of available safety and efficacy data at a minimum of every six months, which we expect in the second quarter of 2023.
Report the second and final interim efficacy analysis from the ENVASARC pivotal trial following the review of more than 12 weeks of efficacy data (including two on-study CT scans) by the IDMC from 46 patients who receive envafolimab as a single agent and 46 patients who receive envafolimab in combination with Yervoy, which we expect in the third quarter of 2023 as the ENVASARC trial has enrolled more than 92 patients to date.
Complete full accrual of the ENVASARC pivotal trial before the end of 2023.
Report Phase 1 data from the Phase 1/2 clinical trial of YH001 in combination with envafolimab and doxorubicin in patients with soft tissue sarcoma, which we expect in the second half of 2023.
First Quarter 2023 Financial Results

Cash and cash equivalents were $6.6 million at March 31, 2023, compared to $17.4 million at December 31, 2022, which is expected to fund the Company into the third quarter of 2023, and with the amounts we expect to recover from I-Mab pursuant to the arbitration award, when received, into early 2024.
Research and development expenses for the first quarter of 2023 were $5.0 million, compared to $3.0 million for the first quarter of 2022. The increase was primarily related to envafolimab drug product purchased in the first quarter of 2023.
General and administrative expenses for the first quarter of 2023 were $2.3 million, compared to $6.5 million for the first quarter of 2022. The decrease was primarily attributable to legal expenses incurred in the first quarter of 2022 in connection with the arbitration hearing with I-Mab.
Net loss for the first quarter of 2023 was $8.5 million, compared to $9.5 million for the first quarter of 2022.
Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial-in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients as well as multiple Phase 1 and Phase 2 clinical trials in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity and complement dependent cytotoxicity in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being studied with envafolimab and doxorubicin in a Phase 1/2 clinical trial sponsored by TRACON (NCT05448820), and has been studied in multiple Phase 1 trials in China and Australia sponsored by TRACON’s corporate partner Eucure, a division of Biocytogen.

About TRC102

TRC102 (methoxyamine) is a novel small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.