On August 10, 2022 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient care journey, reported that financial results for the second quarter 2022, ended June 30, 2022 (Press release, Oncocyte, AUG 10, 2022, View Source [SID1234618045]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter and Recent Highlights:

Recent rightsizing of organization to match new program priorities is expected to reduce headcount carrying costs by over $4.5 million annually and, in combination with reprioritization cost reduction and anticipated strategic activities, annualized operating costs are expected to be reduced by approximately $12 million in 2023 as compared to 2022.
Reported total revenue of $2.1 million in the second quarter of 2022, compared with $2.0 million in the second quarter of 2021.
Received $1.0 million milestone payment from the final delivery of DetermaRx to Burning Rock, our Chinese partner.
Grew DetermaRx sample volume by 66% compared to second quarter of 2021 and increased onboarded physician base by 82% as compared to the same period in 2021.
Launched our CLIA validated laboratory test for our newly branded VitaGraft Liver Transplant Monitoring, a donor-derived cell-free DNA (dd-cfDNA) test.
Submitted VitaGraft Liver and VitaGraft Kidney for CMS reimbursement.
Clinical Partners presented five abstracts at ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper) expanding the evidence supporting DetermaIO as clinically relevant to decision making in six different cancer types including:
Independent, prospective randomized clinical trial (RCT) evidence that DetermaIO can identify responders and expand the market for immune checkpoint inhibitor (ICI) therapy in colorectal cancer.
Phase II independent blinded clinical trial evidence that DetermaIO can inform the use of pembrolizumab therapy (Keytruda) in the neoadjuvant treatment of triple negative breast cancer, expanding upon prior reported RCT data with atezolizumab.
Closed an underwritten offering of $32.8 million in net proceeds of common stock and warrants, and a preferred stock offering of $4.9 million in net proceeds, to strengthen the balance sheet and further support our product portfolio.
"Our recent reprioritization efforts have led to a rightsizing of our employee base to better match the resourcing required to deliver DetermaIO, DetermaCNI and VitaGraft to the market. The expected program cost reductions combined with the reduction in headcount and planned monetization of assets through strategic activities are anticipated to result in a decrease of approximately $12 million in annualized operating expenses year over year, extending our cash runway into 2024," said Ron Andrews, Chief Executive Officer of Oncocyte. "We continued to make solid progress in the second quarter, delivering 66% year over year growth in DetermaRx sample volumes and successfully onboarding new physicians and accounts. We also successfully completed our CLIA lab test validation of our VitaGraft product line and submitted both Liver and Kidney for CMS reimbursement."

Continuing, Mr Andrews commented, "Looking ahead, we are excited by the response to the anticipated launch of our VitaGraft Liver test and expect our first samples from a high-profile liver transplant center by the end of August. We also remain on track to submit our dossier for DetermaIO reimbursement this fall. Despite the continued market headwinds, we believe that Oncocyte has an incredibly bright future in front of us as the product development efforts from the past few years are expected to result in new product launches of high value, reimbursed products over the next four to six quarters. I would also like to recognize the promotion of Anish John to CFO and Gisela Paulsen to President and COO. These are well-deserved promotions for two executives that have been instrumental in reshaping our priorities and helping find ways to reduce our burn while still accomplishing our mission. We are now aligned around key areas where our skill sets can best serve Oncocyte’s future. I appreciate the continued support of our shareholders and look forward to updating you as we work to deliver on the key product milestones throughout the second half of 2022."

Second Quarter 2022 Financial Results

Total revenue was $2.1 million for the second quarter of 2022, compared to $1.4 million for the prior quarter. Second quarter revenues associated with DetermaRx were $0.8 million, down $0.2 million sequentially, and up $0.2 million year over year. Operating expenses for the second quarter 2022 were $8.2 million, compared to $13.2 million, a decrease of $5.0 million from the same period in the prior year. Research and Development expense for the second quarter 2022 was $5.6 million, an increase of $3.0 million from the same period a year ago. The increase in R&D expense was due to full integration of the Chronix R&D team, the growth and enrolment of our clinical trials, and added headcount related to the buildout of our IVD product development capabilities. General and Administrative expense for the second quarter of 2022 was $5.5 million, a decrease of $2.4 million for the same period in 2021, primarily due to one-time acquisition related costs related Chronix Biomedical acquisition in the same period in the prior year. Sales and Marketing expense in the quarter was $3.5 million, an increase of $0.8 million year over year, primarily attributable to an increase in headcount and continued ramp in sales and marketing activities related to the transplant business, as well as support the commercialization efforts within oncology.

Net loss was $8.3 million for the second quarter of 2022 and net loss per share was $0.07 on a weighted-average basic and diluted share count of 113.0 million, compared to a net loss of $10.5 million and a net loss per share of $0.12 on a weighted-average basic and diluted share count of 89.8 million in the same period of the prior year.

Cash, cash equivalents, restricted cash and marketable securities were $47.1 million as of June 30, 2022.

Webcast and Conference Call Information
Oncocyte will host a conference call to discuss the second quarter 2022 financial results after market close on Wednesday, August 10, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (877) 407-9716 for U.S. callers or (201) 493-6779 for international callers, using conference ID: 13731553. The live webinar can be accessed at View Source

On August 10, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a commercial-stage biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease, reported financial results for the second quarter of 2022 and provided an update on recent corporate developments (Press release, Adamis Pharmaceuticals, AUG 10, 2022, View Source [SID1234618044]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I committed to the CEO role in May because I could see beyond Adamis’ current position to where it could go. I knew the Company had strong assets which we could leverage to unlock shareholder value," said David J. Marguglio, CEO of Adamis. "We have two FDA-approved products competing in large markets. We have an ongoing Phase 2/3 trial for Tempol that, if it shows significant efficacy, could not only potentially become a blockbuster treatment for COVID-19, but could be potentially expanded to treat other respiratory diseases. Most importantly, we have a small, yet devoted team of highly qualified and experienced individuals committed to both saving patient lives and growing Adamis."

Product and Pipeline Updates and Other Corporate Developments

ZIMHI (naloxone) Injection

US WorldMeds (USWM) began shipping ZIMHI to wholesalers at the end of March. The commercial launch is proceeding as planned.
USWM-relayed feedback from the field has been decidedly positive. Many customers feel ZIMHI’s combination of a higher dose with intramuscular delivery provides an advantage and significantly differentiates it from the leading competitors.
A recently launched website enables institutional customers to order and receive product directly through ZimhiDirect.com.
Progress continues in adding ZIMHI to formularies for payors and PBMs. It has been added to the standing orders in 25 states – which permits pharmacies to dispense ZIMHI without a prescription.
While market access is increasing, USWM has fielded a team of sales reps detailing doctors and clinics to increase awareness and ultimately drive scripts.
SYMJEPI (epinephrine) Injection

In March, the Company announced that manufacturing issues had led to a voluntary recall of four lots of SYMJEPI due to the potential for clogged needles.
An investigation lasting several months determined a single batch of stainless-steel needles was the root cause of the failures. Adamis and the manufacturer have developed corrective and preventive actions, and new syringes have been sourced.
Adamis is committed to returning SYMJEPI to the market as soon as all stakeholders are satisfied that these corrective actions should prevent a similar failure in future batches.
TEMPOL

Adamis believes that patient enrollment in the Phase 2/3 clinical trial is nearly completed.
The Data Safety Monitoring Board is scheduled to meet near the end of September to review unblinded interim data including safety and efficacy. Adamis will remain blinded to the data until the final study data is compiled and reviewed.
If interim trial data shows significant efficacy, the DSMB may recommend stopping the trial in light of the significant efficacy, and Adamis would likely seek to meet with FDA to discuss next steps and requirements for applying for Emergency Use Authorization, which could be a significant positive development for the Company, patients and healthcare providers.
The Company is exploring other potential indications for Tempol and seeking both government and non-government funding to further development.
Financial Results

Revenues for the six months ending June 30, 2022 and 2021 were approximately $1.2 million and $2.6 million, respectively. The decrease in revenues was primarily due the manufacturing hold and recall of SYMJEPI in 2022, offset by the product launch of ZIMHI.
Selling, general and administrative expenses for the first six months ending June 30, 2022 and 2021 were approximately $7.6 million and $8.5 million, respectively. The decrease was primarily due to the decreases in compensation and legal expenses.
Research and development expenses were higher for the first six months of 2022, at approximately $7.5 million, compared to $4.4 million in the same period in 2021. The increase was primarily related to the ongoing clinical trial for Tempol.
Net loss from discontinued operations for the six months ended June 30, 2022 and 2021 was approximately $0.2 million and $3.1 million, respectively. This decreased loss was primarily attributable to the cessation of US Compounding’s operations.
Cash and cash equivalents at the end of the second quarter totaled $8.9 million. Cash expenses were higher than expected due to approximately $5.2 million in disbursements relating to the repayment of the Second Draw Paycheck Protection Program loan, expenses related to the SYMJEPI recall and employment separation expenses. Although there are no assurances, the Company expects to receive additional proceeds during the second half of 2022, which could range from collections of approximately $2.0 to 3.5 million pursuant to the sale of certain USC assets to Fagron in 2021, and from the disposition of the remaining USC assets.
Conference Call Information

Management will host a live webcast/conference call today, August 10, 2022 at 4:30 p.m. ET / 1:30 p.m. PT, during which Company executives will review financial information for the second quarter of 2022 and provide a corporate update.

A live audio webcast of the conference call will also be available via this link. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at View Source

On August 10, 2022 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immuno-oncology therapeutics for the treatment of cancer, reported financial results for the second quarter ended June 30, 2022 and provided a business update (Press release, Bolt Biotherapeutics, AUG 10, 2022, View Source [SID1234618043]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter was one of continued progress, highlighted by steady clinical enrollment in our BDC-1001 monotherapy and combination dose-escalation studies. While we are fortunate to be operating from a position of financial strength, we have implemented a pipeline prioritization and new capital allocation initiative focused on advancing BDC-1001 and BDC-3042, two drug candidates that we believe have high potential to benefit patients," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We are winding down spending on BDC-2034, pausing other early-stage research programs, and prioritizing ISAC programs that bring forward the latest generation of our ISAC technology – including our collaboration programs. The combination of these strategic initiatives extends our expected cash runway an additional two years through 2025."

Dr. Schatzman continued, "We have a lot to look forward to with strong investigator and collaborator interest in our programs, data readouts from the BDC-1001 monotherapy and combination dose-escalation studies on the horizon as well as the advancement of BDC-3042 through IND-enabling activities."

Recent Business Highlights and Anticipated Milestones

Clinical data and recommended Phase 2 dose (RP2D) expected in the second half of 2022 from BDC-1001 monotherapy and combination dose-escalation study – Weekly dosing is well underway in the Phase 1/2 multi-dose, multi-center study of BDC-1001, a HER2-targeting Boltbody immune-stimulating antibody conjugate (ISAC), in monotherapy and in combination with Bristol Myers Squibb’s PD-1 checkpoint inhibitor Opdivo (nivolumab).
To date, BDC-1001 has demonstrated a favorable safety profile, changes in intratumoral biomarkers consistent with its novel mechanism of action, and early signs of durable clinical disease control.
Completed companywide review and prioritization of portfolio and capital allocation strategy – Bolt now expects its current cash position to fund operations for an additional two years through 2025 based on the following initiatives:
Focus on development of our internal BDC-1001 and BDC-3042 programs while advancing next-generation ISAC technology and programs with partners.
Discontinue development of BDC-2034 and focus on most promising next-generation ISAC programs, including our collaborations. The decision to discontinue BDC-2034 was based on off-target toxicity related to the targeting antibody. CEA remains a viable Boltbody ISAC target with a more selective antibody
BDC-3042 advancing toward the clinic in 2023; IND-enabling studies underway – BDC-3042 is an agonist antibody that stimulates Dectin-2, a novel target found on tumor-associated macrophages across a broad range of solid tumors. Stimulating Dectin-2 leads to tumor macrophage reprogramming and anti-cancer activity in our preclinical studies. Bolt is currently conducting IND-enabling studies for BDC-3042 and is on track to initiate clinical development of BDC-3042 in 2023.
Presented poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting – In June, Bolt presented ex vivo data demonstrating that myeloid cells are abundant in many solid tumors, even when T cells are not present. These data support the potential for myeloid-directed therapies to activate the innate immune system as a bridge to adaptive immunity in patients, independent of T cell-mediated immune checkpoint blockade.
Presented data from three preclinical pipeline programs at the 2022 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting – In April, Bolt Biotherapeutics’ scientists presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting 2022 highlighting the Company’s proprietary pipeline, including BDC-2034, BDC-3042, and a PD-L1 Boltbody ISAC.
Third U.S. patent issued covering lead HER2-targeting Boltbody ISAC BDC-1001 – The U.S. Patent and Trademark Office (USPTO) issued the U.S. Patent 11,400,164 on Aug. 2, 2022, titled "Immunoconjugates Targeting HER2." This U.S. patent strengthens the Company’s intellectual property position and contains composition of matter claims covering BDC-1001. This patent provides the Company coverage on the composition of matter of BDC-1001 until 2040, without any patent term extension.
Cash, cash equivalents, and marketable securities were $223.6 million as of June 30, 2022 – Cash on hand, including long-term marketable securities, is expected to fund multiple key milestones and operations through 2025.
Second Quarter 2022 Financial Results

Collaboration Revenue – Collaboration revenue was $1.4 million for the quarter ended June 30, 2022, compared to $0 for the same quarter in 2021. This represents 75% growth over the first quarter of 2022 as Bolt ramps up activities supporting its collaborations. Revenue in 2022 was generated from the services performed under the R&D collaborations with Genmab A/S and Innovent Biologics, Inc.
Research and Development (R&D) Expenses – R&D expenses were $18.9 million for the quarter ended June 30, 2022, compared to $19.7 million for the same quarter in 2021. The decrease was primarily due to a reduction in manufacturing expenses, offset by an increase in expenses due to continued progress in our clinical trial for BDC-1001 and the development of other product candidates, including an increase in contract and consulting services and higher personnel-related expenses relating to an increase in headcount.
General and Administrative (G&A) Expenses – G&A expenses were $5.5 million for the quarter ended June 30, 2022, compared to $4.1 million for the same quarter in 2021, primarily due to increased expenses related to being a public company, including higher personnel expenses relating to increased headcount.
Loss from Operations – Loss from operations was $23.1 million for the quarter ended June 30, 2022, compared to $23.8 million for the same quarter in 2021.
About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform unites the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment for a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lowering the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response, with the goal of generating durable therapeutic responses for patients with cancer.

On August 10, 2022 NightHawk Biosciences (NYSE American: NHWK), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported strategic, financial, and operational updates for the second quarter ended June 30, 2022 (Press release, NightHawk Biosciences, AUG 10, 2022, View Source [SID1234618042]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jeff Wolf, Chief Executive Officer of NightHawk, commented, "We continue to advance our evolution towards becoming a fully-integrated biopharmaceutical company via our subsidiary ecosystem. Specifically, we are on track to open the Scorpion San Antonio biologics manufacturing facility in Q3 and are actively progressing development efforts for our newly-announced commercial scale biomanufacturing facility in Manhattan, Kansas. We intend to provide a full suite of CDMO manufacturing and bioanalytic services to biopharmaceutical clients. I’m pleased to report that feedback from prospective customers has been positive, and we look forward to commercial announcements in the near-term."

"On the clinical front, we continue to evaluate a variety of strategic options for our HS-110 and PTX-35 programs moving forward. Our Elusys subsidiary recently executed a contract to deliver ANTHIM to Canada’s National Emergency Strategic Stockpile, our first sale of ANTHIM outside the United States. Finally, we continue to advance our research efforts and expand our pipeline through ongoing development at our Skunkworx subsidiary. Overall, we are extremely encouraged by the outlook for the business and look forward to providing further updates on our growing pipeline and commercial activities."

Second Quarter 2022 Financial Results

Recognized $0.05 million of contract revenue for the quarter ended June 30, 2022 compared to $0.5 million of grant and contract revenue for the quarter ended June 30, 2021. The decrease in grant revenue in the current-year period is due to the fact that we recognized all $15.2 million of grant revenue during 2021. As of June 30, 2022, we had a grants receivable balance of $1.5 million for CPRIT proceeds not yet received, but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
Research and development expenses were $4.7 million for the three months ended June 30, 2022 compared to $4.2 million for the three months ended June 30, 2021. The increase was primarily due to expenses associated with the ongoing Phase 1 clinical trial of PTX-35, integration costs associated with ANTHIM, as well as unallocated research expenses consisting of personnel costs, including stock-based compensation from stock awards, contractor expense and supplies purchased for discovery projects.
General and administrative expenses were $4.9 million and $2.9 million for the three months ended June 30, 2022 and 2021, respectively. The increase was due to increased labor and consulting costs, additional facility and office expenses and other professional services, and an increase in stock-based compensation expense.
Net loss attributable to NightHawk Biosciences was approximately $10.2 million, or ($0.40) per basic and diluted share for the three months ended June 30, 2022, compared to approximately $6.5 million, or ($0.26) per basic and diluted share for the three months ended June 30, 2021.
As of June 30, 2022, the Company had approximately $69.9 million in cash and cash equivalents.

On August 10, 2022 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 second quarter ended June 30, 2022 (Press release, Tracon Pharmaceuticals, AUG 10, 2022, View Source [SID1234618041]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to have robust accrual in the ENVASARC pivotal trial as we have enrolled more than 36 patients and look forward to reporting the interim efficacy analysis on the initial 36 patients in the fourth quarter, after each patient has had two on-study scans." said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Additionally, we await the outcome of the binding arbitration relating to I-Mab’s alleged breaches of the TJ4309 and bispecific antibody agreements, and anticipate completing the TJ4309 Phase 1 trial that permits I-Mab the opportunity to terminate the license for a $9M payment to TRACON. We expect both the arbitration decision and the termination of the TJ4309 license to occur this year."

Recent Corporate Highlights

In June, we announced a registered direct financing of approximately $4.0 million in the aggregate with an accredited institutional healthcare-focused fund, which was completed at market price.

In July, we announced the enrollment of the 36th patient in the ENVASARC Phase 2 pivotal trial at the 600 mg dose of envafolimab.

In August, we announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.

In August, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC trial proceed as planned following the review of more than three weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.
Expected Key 2022 Milestones

Report the interim safety analysis by the IDMC following the review of more than twelve weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.

Report the interim efficacy analysis by the IDMC following the review of more than twelve weeks of efficacy data from 36 patients who received the 600 mg dose of envafolimab as a single agent or with Yervoy.

Initiate dosing in the Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001 as well as with doxorubicin chemotherapy.

Report the International Chamber of Commerce (ICC) Arbitration Panel’s (the Tribunal) binding decision in the ongoing arbitration involving the TJ4309 and bispecific antibody agreements with I-Mab Biopharma where we are seeking to recover over $200 million in damages.

Complete the TJ4309 Phase 1 clinical trial permitting I-Mab the opportunity to terminate the TJ4309 license for a $9.0 million payment to TRACON.
Second Quarter 2022 Financial Results

Cash and cash equivalents were $13.6 million at June 30, 2022, compared to $24.1 million at December 31, 2021 and is expected to fund the company into 2023.

Research and development expenses for the second quarter of 2022 were $2.9 million, compared to $3.1 million for the second quarter of 2021.

General and administrative expenses for the second quarter of 2022 were $3.3 million, compared to $6.1 million for the second quarter of 2021. The decrease was primarily attributable to legal expenses incurred in the second quarter of 2021 due to the now stayed lawsuit filed by I-Mab in the Delaware Court of Chancery involving the TJ4309 agreement.

Net loss for the second quarter of 2022 was $6.2 million, compared to $8.9 million for the second quarter of 2021.
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, 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 in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

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 (ADCC) and complement dependent cytotoxicity (CDC) 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 dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

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.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.