On August 10, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the second quarter ended June 30, 2023, and provided an overview of recent developments (Press release, UroGen Pharma, AUG 10, 2023, View Source [SID1234634222]).

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"We are in a transformative period for UroGen," said Liz Barrett, President and Chief Executive Officer of UroGen Pharma. "Recently, we announced positive topline results from the ATLAS and ENVISION Phase 3 clinical trials of UGN-102 in LG-IR-NMIBC. Both trials met their primary endpoints, demonstrating consistent, compelling results for UGN-102. If approved, we believe UGN-102’s promising efficacy and safety profile across multiple trials support a potential shift from frequent surgeries to a minimally invasive, non-surgical option for the more than 82,000 underserved LG-IR-NMIBC patients diagnosed annually in the U.S. alone, positioning it as a potential key growth driver for UroGen."

"Furthermore, increased adoption and expansion of JELMYTO use in a diverse LG-UTUC population, supported by a growing database of real-world outcomes data, translated to notable revenue growth during the second quarter of 2023," continued Ms. Barrett. "Building on these achievements, the recently announced $120 million private placement of ordinary shares and pre-funded warrants with a select group of biotech investors provides us with the resources to support our business, including our prospective pre-commercialization and launch strategy for UGN-102."

Business Highlights:

UGN-102 (mitomycin) for intravesical solution:

The ENVISION Phase 3 clinical trial met its primary endpoint by demonstrating a 79.2% rate of complete response among ~240 LG-IR-NMIBC patients at 3-months after the first UGN-102 instillation.
Additional data evaluating the secondary endpoint of duration of response from ENVISION, and the submission of a New Drug Application (NDA) (assuming additional positive findings) to the U.S. Food and Drug Administration (FDA) are anticipated in 2024.
The Journal of Urology published a peer-reviewed article highlighting that the ATLAS Phase 3 clinical trial met its primary endpoint of disease-free survival, with topline results demonstrating a reduced risk of recurrence, progression, or death of 55% for UGN-102 + TURBT compared to TURBT monotherapy.

Patients who only received UGN-102 showed a 64.8% complete response rate at three months, compared to a 63.6% complete response rate at three months for patients who only received TURBT.

The estimated probability of remaining disease free 15-months after randomization was 72% for UGN-102 ± TURBT and 50% for TURBT monotherapy (hazard ratio 0.45).
UroGen hosted an event to discuss and highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials on July 27th, 2023. A replay of the event is available on the UroGen website at View Source
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):

Generated record quarterly net product revenue of $21.1 million for the second quarter of 2023, representing ~27% growth over the second quarter of 2022.
Activated sites on August 1, 2023 were 1,058, compared to 1,009 on May 1, 2023, while repeat accounts on August 1, 2023 were 267, compared to 235 on May 1, 2023.
Results from a retrospective study investigating whether patients with higher-volume low-grade disease could achieve disease-free status using partial ablation or biopsy before JELMYTO treatment during initial ureteroscopy (URS) showed no significant difference in rendered disease-free rates between complete ablation (78.6%), partial ablation (57.6%), or biopsy-only (66.7%) groups during initial URS (p=0.15). The analysis also showed that tumor size prior to JELMYTO induction did not have a significant impact on rendered disease free (RDF) rates (p=0.09). The study aimed to find alternatives to nephroureterectomy for preserving kidney function and to assess JELMYTO’s efficacy in managing larger volume disease.
Private Placement of Ordinary Shares

Completed a private placement of ordinary shares and pre-funded warrants with gross proceeds of approximately $120 million before deducting placement agent commissions and other offering expenses to select institutional and accredited investors.
Second Quarter 2023 Financial Results:

JELMYTO Revenue: UroGen reported net product revenue of JELMYTO for the second quarter 2023 of $21.1 million, compared to $16.6 million in the second quarter of 2022.

R&D Expense: Research and development expenses for the second quarter 2023 were $11.6 million, including non-cash share-based compensation expense of $0.5 million as compared to $12.6 million, including non-cash share-based compensation expense of $0.7 million, for the same period in 2022.

SG&A Expense: Selling, general and administrative expenses for the second quarter 2023 were $22.5 million, including non-cash share-based compensation expense of $1.7 million. This compares to $20.8 million, including non-cash share-based compensation expense of $2.2 million, for the same period in 2022.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.3 million for the second quarter 2023, compared to $5.8 million for the same period in 2022. The rate applied to cash payments incurred in 2023 is 13% based on global net product sales of JELMYTO in 2022.

Interest Expense on Long-Term Debt: Interest expense related to the $100 million term loan facility with funds managed by Pharmakon Advisors was $3.8 million for the second quarter of 2023, compared to $2.2 million for the same period last year due to the transaction closing in March 2022 and the final $25 million draw down under the term loan facility in December 2022.

Net Loss: UroGen reported a net loss of $24.1 million, or basic and diluted net loss per ordinary share of $1.03, for the second quarter 2023 as compared to $26.7 million, or basic and diluted net loss per ordinary share of $1.18, for the same period in 2022.

Cash & Cash Equivalents: As of June 30, 2023, cash, cash equivalents and marketable securities totaled $55.3 million. This figure does not include proceeds from the recent $120 million private placement of ordinary shares and pre-funded warrants.

2023 Revenue, Operating Expense and RTW Expense Guidance: The Company reiterates anticipated full year 2023 net product revenues from JELMYTO to be in the range of $76 to $86 million. The Company also reiterates anticipated full year 2023 operating expenses in the range of $135 to $145 million, including non-cash share-based compensation expense of $6.0 to $11.0 million, subject to market conditions. The Company also reiterates anticipated full year 2023 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $21.0 to $26.0 million. Of this amount approximately $9.9 to $11.2 million is expected to be in cash.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per ml gel indicated for primary chemoablative treatment of LG-UTUC in adults. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

About Upper Tract Urothelial Cancer (UTUC)

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive secondary endpoint findings from the ENVISION Phase 3 study, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024. If approved, UGN-102 would be the first non-surgical primary therapeutic to treat a subset of bladder cancer characterized by high recurrence rates and multiple surgeries.

About the Phase 3 ENVISION Trial

The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) for intravesical solution as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The Phase 3 ENVISION trial completed target enrollment with approximately 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of UGN-102. The primary endpoint evaluated the complete response rate at the 3-month assessment after the first instillation, and the key secondary endpoint will evaluate durability over time in patients who achieved a complete response at the three-month assessment. Based on discussions with the FDA, and assuming positive secondary endpoint findings, UroGen anticipates submitting an NDA for UGN-102 in 2024. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).

About the Phase 3 ATLAS Trial

ATLAS was a global, open-label, randomized controlled Phase 3 trial designed to assess the efficacy and safety of UGN-102, with or without TURBT, vs. TURBT alone in patients diagnosed with LG-IR-NMIBC. The trial enrolled 282 patients in clinical sites in the U.S., Europe and Israel. Patients were randomized 1:1 to either UGN-102 + / – TURBT or TURBT. Patients in the UGN-102 arm were treated with six weekly intravesical instillations of UGN-102. At the 3-month time point, patients were assessed for response. Patients who demonstrated a complete response to either UGN-102 or TURBT, were assessed for long-term follow-up for evidence of recurrence. Patients who demonstrated presence of persistent disease at 3-months, in either arm, underwent a TURBT and continued for long-term follow-up for evidence of recurrence. The primary endpoint of the study is disease-free survival. Learn more about the ATLAS trial at www.clinicaltrials.gov (NCT04688931).

On August 10, 2023 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the quarter ended June 30, 2023 and highlighted recent corporate progress (Press release, Tyra Biosciences, AUG 10, 2023, View Source [SID1234634221]).

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"TYRA is a precision medicine biotech company focused on large opportunities in FGFR biology, and we continued to advance our pipeline and approach during the last several months," said Todd Harris, CEO of TYRA. "We believe that TYRA-300, our oral FGFR3-selective inhibitor, is potentially a best-in-class agent designed to address unmet needs in oncology and skeletal dysplasias. Our SURF301 oncology study remains on target, and we are pleased to receive Orphan Drug Designation for TYRA-300 in achondroplasia from the U.S. FDA. This is another important milestone in the development of TYRA-300, and we are excited about the opportunity to deliver a new therapeutic option for patients."

Second Quarter 2023 and Recent Corporate Highlights

TYRA-300

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Granted Orphan Drug Designation from U.S. FDA for Achondroplasia. In July 2023, TYRA-300, an investigational oral FGFR3-selective inhibitor, was granted Orphan Drug Designation (ODD) for the treatment of achondroplasia. TYRA remains on track to submit an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to enable a Phase 2 study of TYRA-300 in pediatric achondroplasia in 2024.
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SURF301 Phase 1/2 Study for Oncology is On Target. SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552) is a multi-center, open label study designed to determine the optimal and maximum tolerated doses and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. The study remains on target and enrollment is ongoing in Part A and Part B in Phase 1 of the study at multiple clinical sites in the U.S., Europe, and Australia.

TYRA-200

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Advanced Preparation Activities for Phase 1 Study. TYRA continued to advance activities for its planned Phase 1 clinical study of TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations, during the second quarter of 2023. The trial will be focused on intrahepatic cholangiocarcinoma resistant to prior FGFR inhibitors. TYRA remains on track to dose the first patient in this trial in the second half of 2023.

SNÅP Platform and Pipeline

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TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions including FGF19+/FGFR4-driven cancers and RET (REarranged during Transfection kinase) driven cancers.

Corporate

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Strengthened Leadership. TYRA made key senior appointments including Dr. Michael Bober, Vice President, Clinical Development and Medical Affairs, who, prior to joining TYRA, served as the Medical Director of the Skeletal Dysplasia Program, Nemours Children’s Hospital, Delaware, and is a key opinion leader in the skeletal dysplasia community. Additionally, TYRA appointed George Melko, Vice President, Regulatory Affairs and Gary Price, Vice President, Quality.

Second Quarter 2023 Financial Results

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Second quarter 2023 net loss was $13.3 million compared to $15.1 million for the same period in 2022.
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Second quarter 2023 research and development expenses were $12.2 million compared to $12.0 million for the same period in 2022.
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Second quarter 2023 general and administrative expenses were $3.9 million compared to $3.4 million for the same period in 2022.
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As of June 30, 2023, TYRA had cash and cash equivalents of $232.4 million that will support TYRA’s important clinical and operational milestones over at least the next two years.

About TYRA-300

TYRA-300 is the Company’s lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasias including achondroplasia. TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). SURF301 (NCT05544552) was designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations. In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results and the Company expects to submit an IND for the initiation of a Phase 2 clinical study in pediatric achondroplasia in 2024.

On August 10, 2023 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor-engineered T cell therapies (TCR-Ts) for the treatment of patients with cancer, reported financial results and provided a corporate update for the second quarter ended June 30, 2023 (Press release, TScan Therapeutics, AUG 10, 2023, View Source [SID1234634220]).

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"The success of the second quarter has been a testament to the hard work here at TScan over the last six months," said Gavin MacBeath, Ph.D., Chief Executive Officer. "We are encouraged by the initial clinical data from our heme malignancies program and look forward to reaching the recommended Phase 2 dose for both TSC-100 and TSC-101 and providing a more extensive update by the end of this year. We continue to successfully enroll and treat patients in the dose escalation portion of the Phase 1 study and have not observed any dose limiting toxicities to date. Both TCR-T product candidates are now proceeding through dose level 2. With regards to the solid tumor program, we continue to focus our efforts on populating the ImmunoBank with TCR-Ts that address different targets and diverse HLA types to enable tailored, multiplexed TCR-T therapies. Following the close of an underwritten public offering in June, we are well capitalized to execute on upcoming anticipated milestones into 2026, by which time we expect to report data for both clinical programs."

Corporate Highlights

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In May 2023, the Company presented preliminary data from its ongoing multi-arm Phase 1 clinical trial evaluating TSC-100 and TSC-101, two different TCR-T cell therapy product candidates that are designed to treat residual disease and prevent relapse following hematopoietic cell transplantation in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or acute lymphocytic leukemia (ALL). Data were presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting 2023. Both TSC-100 and TSC-101 showed markers of T cell activation and proliferation in patients, with no dose limiting toxicities. The Company also reported donor chimerism data for three patients. Two medium-risk MDS patients in the control arm showed incomplete donor chimerism, whereas the high-risk MDS patient in the TSC-101 arm showed complete donor chimerism within three weeks of receiving the

engineered TCR-T cell product. The study is now advancing to dose level 2 in both the TSC-100 and TSC-101 arms. TScan remains on track to reach the recommended Phase 2 dose for both products and report interim clinical data for the program by the end of 2023.

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The Company recently announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for TSC-200-A0201, a TCR-T targeting the E7 protein of human papillomavirus 16 (HPV16). TSC-200-A0201 is the third TCR-T cleared to initiate clinical development in the Company’s solid tumor program. TSC-204-A0201 and TSC-204-C0702, which target MAGE-A1 presented on HLA types A*02:01 and C*07:02, respectively, were cleared earlier this year. TScan is on-track to initiate clinical development of all three TCR-T candidates in a multi-arm Phase 1 basket study in the second half of 2023. The clinical trial, which has received clearance from the FDA, is designed to assess the safety and efficacy of each candidate individually at two different dose levels, and then to assess custom combinations of TCR-Ts at dose levels 3 and 4 in patients that qualify to receive more than one therapeutic candidate. TScan plans to file INDs for three additional TCR-T candidates by year end, including a TCR-T that targets the tumor-associated antigen PRAME. Upon FDA clearance, these candidates will be introduced into the ongoing clinical trial, thereby increasing patient eligibility for multiplexed TCR-T cell therapy.

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During the second quarter, TScan announced the closing of an underwritten public offering with net proceeds of approximately $134.7 million. The Company intends to use the proceeds for general corporate purposes. Following this offering, the Company expects that its existing cash and cash equivalents, along with proceeds from the collaboration agreement with Amgen, will fund its operating expenses and capital expenditure requirements into 2026.

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In June 2023, TScan presented a trial in progress poster for its solid tumor program at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. A copy of the poster can be found on the "Publications" section of the Company’s website at www.tscan.com.

Upcoming Anticipated Milestones

Heme Malignancies Program:

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Expects to reach the recommended Phase 2 dose for both TSC-100 and TSC-101 and report interim clinical data for the program by the end of 2023.
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Plans to complete Phase 1 dosing and report prevention of relapse data in 2024.

Solid Tumor Program:

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Anticipates further expansion of the ImmunoBank with the recent filing of an IND for TSC-203-A0201, an HLA-A*02:01-restricted TCR targeting PRAME, and IND filings for two additional TCRs by year-end.
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Plans to initiate Phase 1 solid tumor clinical study in the second half of 2023 and anticipates sharing preliminary data by the end of 2023.

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Expects to report initial multiplexed therapy data for its first combinations of TCR-Ts under T-Plex, as well as response data for singleplex cohorts, in 2024.

Second Quarter 2023 Financial Results

As of June 30, 2023, TScan Therapeutics had cash and cash equivalents of $208.8 million, excluding $5.0 million of restricted cash. Based on current operating plans, the Company believes that existing cash and cash equivalents, along with proceeds from the collaboration with Amgen, will be sufficient to fund its operating expenses and capital expenditure requirements into 2026.

Revenue for the second quarter ended June 30, 2023, was $3.1 million, compared to $4.1 million for the second quarter ended June 30, 2022 (2022 Quarter). This decrease is primarily due to timing of research activities related to the collaboration agreement with Amgen in the second quarter of 2023 versus timing of research activities related to a collaboration and license agreement with Novartis Institutes for Biomedical Research, Inc. in the 2022 Quarter.

Research and development expenses for the second quarter ended June 30, 2023, were $21.2 million, compared to $14.5 million for the 2022 Quarter. The increase of $6.7 million was primarily driven by increased costs associated with clinical trial start-up fees and patient enrollment, increased personnel costs, and expansion of facilities.

General and administrative expenses for the second quarter ended June 30, 2023, were $6.5 million, compared to $4.8 million for the 2022 Quarter. The increase of $1.7 million in general and administrative expenses was primarily driven by increased legal fees related to transactions entered into during the second quarter of 2023.

For the second quarter ended June 30, 2023, TScan Therapeutics reported a net loss of $24.0 million, compared to a net loss of $15.1 million for the 2022 Quarter.

As of June 30, 2023, the Company had issued and outstanding shares of 47,818,766, which consists of 43,542,178 shares of voting common stock and 4,276,588 shares of non-voting common stock, and outstanding pre-funded warrants to purchase 47,010,526 shares of common stock at an exercise price of $0.0001 per share.

On August 10, 2023 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies, reported business highlights and highlighted financial results for the second quarter ended June 30, 2023 (Press release, Theseus Pharmaceuticals, AUG 10, 2023, View Source [SID1234634219]).

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"We are excited to be advancing our pipeline, including lead candidate THE-349, a potential best-in-class fourth generation EGFR inhibitor, and continue to expect an IND submission for THE-349 in EGFR-mutant NSCLC in the fourth quarter of this year. Additionally, we look forward to nominating development candidates from our BCR-ABL and next-generation KIT programs in the first half of next year," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "While we are disappointed by the outcome of the THE-630 program in GIST patients, we believe the update announced today supports the exploration of THE-630 in mast cell-driven diseases, which we anticipate pursuing internally or through a partnership."

Pipeline Highlights and Upcoming Expected Milestones:

THE-349 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) product candidate with activity against single-, double-, and triple-mutant EGFR variants, including T790M and C797X, found in EGFR-mutant non-small cell lung cancer (NSCLC) that has developed resistance to first- or later-line osimertinib.
•Preclinical data demonstrate that THE-349 can potently inhibit all major classes of EGFR activating and resistance mutations observed in a post-first- or later-line osimertinib setting, possesses kinome and wild-type EGFR selectivity, and has central nervous system (CNS) activity.
•IND-enabling toxicology studies have been completed, and Theseus remains on track to submit an Investigational New Drug Application (IND) for THE-349 in the fourth quarter of 2023, and commence its clinical program as soon as possible thereafter, subject to clearance of the IND by the U.S. Food and Drug Administration.
BCR-ABL Program: Theseus is aiming to develop a potent and selective, next-generation, pan-variant BCR-ABL TKI candidate that optimizes the balance of safety and efficacy for patients with relapsed/refractory chronic myelogenous leukemia (CML) and patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
•Theseus plans to pursue clinical development in patients with CML who have been previously treated with a second-generation TKI or have the T315I mutation, and in newly diagnosed patients with Ph+ ALL.
•Preclinically, Theseus lead molecules have shown a high degree of potency against BCR-ABL and clinically relevant resistance mutations, such as the T315I gatekeeper mutation, and substantial kinome selectivity.
•Theseus expects to nominate a development candidate for this program in the first half of 2024.

Next-Generation KIT Program: Theseus is aiming to develop a potent and selective pan-variant TKI candidate targeting all major activating and resistance KIT mutations for treatment of early-line gastrointestinal stromal tumors (GIST).
•Theseus has maintained an extensive medicinal chemistry effort to target KIT, which has led to the discovery of a series of chemically distinct, highly selective, pan-variant KIT inhibitors for the treatment of early-line GIST.
•Theseus plans to nominate a development candidate from this series in the first half of 2024.
THE-630: In July, Theseus discontinued enrollment in its phase 1/2 study of THE-630 in patients with GIST. Theseus subsequently analyzed trial data to inform the feasibility of developing low dose THE-630 for KIT-associated mast cell-driven inflammatory indications.

•Theseus measured levels of serum tryptase, a biomarker for mast cell activation, in GIST patients treated with once-daily oral THE-630 in the phase 1 dose escalation trial at doses of 4 mg to 18 mg.
•Dose-dependent and sustained reductions in serum tryptase observed at all doses, including reductions below detection limit of the assay in some patients, seen at first timepoint (day 8).
•Theseus is evaluating next steps for potential plans to explore doses of 9 mg and below in clinical studies in patients with mast cell-driven diseases, such as chronic urticaria. The safety profile at these doses was generally favorable in GIST patients.

Second Quarter Financial Results:

Cash Position: As of June 30, 2023, Theseus had cash, cash equivalents, and marketable securities of $234.2 million, as compared to $211.8 million as of December 31, 2022. Theseus expects its current cash, cash equivalents, and marketable securities to fund operations and capital expenditures into 2026 based on its current operating plan.
R&D Expenses: Research and development expenses were $12.9 million for the second quarter of 2023, as compared to $7.3 million for the same period in 2022. This increase was primarily due to a $2.1 million increase in expense for preclinical studies and drug manufacturing to support THE-349 IND enabling studies, a $1.2 million increase in development expense related to discovery programs, as well as a $1.6 million increase in employee-related costs driven by an increase in headcount.

G&A Expenses: General and administrative expenses were $4.7 million for the second quarter of 2023, consistent with the expense for the same period in 2022.
Net Loss: Net loss was $14.8 million for the second quarter of 2023, as compared to a net loss of $11.6 million for the same period in 2022.

On August 10, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-classi therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended June 30, 2023 and provided a corporate update (Press release, Tempest Therapeutics, AUG 10, 2023, View Source [SID1234634218]).

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"2023 continues to be a productive and potentially transformative year for Tempest," said Stephen Brady, chief executive officer of Tempest. "In the second quarter, we presented data from our second clinical program, TPST-1495, the company’s novel dual EP2/EP4 antagonist designed to selectively modulate the prostaglandin pathway, both at ASCO (Free ASCO Whitepaper) and in a paper published in Cancer Research Communications. These presentations were made on the heels of announcing early exciting triplet data from our lead TPST-1120 program demonstrating a clinically-meaningful improvement over standard of care alone in first-line HCC patients in an ongoing, global, randomized Phase 1b/2 study. We expect to be able to discuss an updated and comprehensive data set from the formal review of this trial in the second half of 2023."

Recent Highlights

TPST-1120 (clinical PPARα antagonist): announced positive early results from the ongoing randomized first-line HCC study comparing TPST-1120 combined with the standard-of-care regimen of atezolizumab and bevacizumab, with head-to-head to standard-of-care alone. The data were positive in multiple categories, and demonstrated a favorable safety profile:
Unconfirmed responses of 30% for the TPST-1120 triplet arm (12/40) vs. 17.2% for the active control arm (5/29), demonstrating a 74.4% relative improvement in objective response rate (ORR);
Confirmed responses of 17.5% for the TPST-1120 triplet arm (7/40) vs. 10.3% for the active control arm (3/29), demonstrating a 69.9% relative improvement in confirmed ORR;
47.5% (19/40) of the TPST-1120 arm patients are on treatment vs. 23.3% (7/30) in the control arm; and
80% (32/40) of the TPST-1120 arm patients are on study vs. 50% (15/30) in the control.ii
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) presented data from a Phase 1 study evaluating TPST-1495 as a monotherapy and in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in advanced solid tumors at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting; (ii) published mechanism of action data highlighting the increased potency of the molecule against prostaglandin-driven tumor models in Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper); and (iii) continued enrollment of an endometrial cancer-specific arm investigating the two highest doses of TPST-1495 in combination with pembrolizumab.

Potential Upcoming Milestones

TPST-1120 (clinical PPARα antagonist): we expect to be able to discuss an updated and comprehensive data set from the formal review of the ongoing, global, randomized Phase 1b/2 study in first-line liver cancer patients in the second half of 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): we plan to report data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer in 2024.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): we expect to advance new proprietary small molecule series TREX1 inhibitors generated through insights resulting from human TREX1-inhibitor co-crystal structures.

Financial Results

Second Quarter 2023

Tempest ended the second quarter with $17.6 million in cash and cash equivalents, compared to $31.2 million on December 31, 2022.
Net loss and net loss per share for the quarter ended June 30, 2023 were $7.6 million and $0.54, respectively, compared to $9.2 million and $0.79, respectively, for the same period in 2022.
Research and development expenses for the quarter ended June 30, 2023 were $4.4 million compared to $5.7 million for the same period in 2022. The decrease was primarily due to a decrease in costs incurred from contract research organizations and third-party vendors, partially offset by an increase in personnel costs, as well as facilities expenses.
General and administrative expenses for the quarter ended June 30, 2023 were $3.1 million. The decrease was primarily due to a decrease in consulting and professional expenses.

Year-to-Date

Net cash used in operations for the six months ended June 30, 2023 was $14.7 million.
Net loss and net loss per share for the six months ended June 30, 2023 were $15.2 million and $1.09, respectively, compared to $17.7 million and $1.88, respectively, for the same period in 2022.
Research and development expenses for the six months ended June 30, 2023 were $9.1 million compared to $10.8 million for the same period in 2022. The $1.7 million decrease was primarily due to a decrease in costs incurred from contract research organizations and third-party vendors, partially offset by an increase in personnel costs, as well as facilities expenses.
General and administrative expenses for the six months ended June 30, 2023 were $6.0 million compared to $6.2 million for the same period in 2022. The $0.2 million decrease was primarily due to a decrease in consulting and professional expenses.