On May 13, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended March 31, 2022 and provided a corporate update (Press release, Tempest Therapeutics, MAY 13, 2022, View Source [SID1234614524]).

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"The team continued to execute well throughout the first quarter of this year, enabling us to present the first clinical data from a Tempest program at the ASCO (Free ASCO Whitepaper) Annual Meeting in June," said Stephen R. Brady, chief executive officer of Tempest. "We look forward to the upcoming oral presentation, which will highlight the clinical profile and responses observed in the monotherapy and combination Phase 1 study of TPST-1120, our novel PPARa antagonist."

________________________
1 If approved by the FDA

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) completed enrollment in the Phase 1 monotherapy and combination dose escalation arms; (ii) announced that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) accepted for an oral presentation at its 2022 Annual Meeting an abstract containing the TPST-1120 Phase 1 monotherapy and combination data; and (iii) continued enrollment in first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating both monotherapy and combination (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing an RP2D; (ii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting; and (ii) announced that ASCO (Free ASCO Whitepaper) accepted for a poster presentation a "trials in progress" for the ongoing TPST-1495 Phase 1 clinical monotherapy and combination therapy clinical trial.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the AACR (Free AACR Whitepaper) 2022 Annual Meeting.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): (i) first presentation of clinical data from a Tempest program at the oral presentation of the Phase 1 monotherapy and combination data at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting; and (ii) objective response data from the first 40 HCC patients in the first-line randomized study expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) presentation of "trial in progress" poster at ASCO (Free ASCO Whitepaper) 2022 Annual Meeting; and (iii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the second half of 2022.
PIPE Financing

On April 27, we announced a $15 million private investment in public equity (PIPE) financing to EcoR1 Capital, LLC and Versant Venture Capital.
Financial Results

First Quarter

Tempest ended the first quarter of 2022 with $45.8 million in cash and cash equivalents, compared to $51.8 million at December 31, 2021. The decrease was primarily due to cash used in operations of $7.1 million offset by proceeds from sales under our ATM program of $1.4 million. Cash balance does not reflect $15 million raised in April from PIPE financing.
Net cash used in operations for the quarter ended March 31, 2022 was $7.1 million compared to $6.3 million for the same period in 2021.
Net loss and net loss per share for the quarter ended March 31, 2022 were $8.5 million and $1.18, respectively, compared to $5.4 million and $10.55, respectively, for the first quarter of 2021.
Research and development expenses for the first quarter of 2022 were $5.1 million compared to $3.6 million for the same period in 2021. The $1.5 million increase was primarily attributable to expanded research and development efforts and increased fees for consulting services and compensation expenses.
For the three months ended March 31, 2022, general and administrative expenses were $3.0 million compared to $1.5 million for the same period in 2021. The increase of $1.5 million was primarily due to higher professional and consulting fees, insurance, and compensation expenses.

On May 13, 2022 UroGen Pharma Ltd. (Nasdaq: URGN) reported that highlighted four presentations of interest featuring data on JELMYTO (mitomycin) for pyelocalyceal solution for patients with low-grade upper tract urothelial cancer (LG-UTUC) and investigational agent UGN-102 (mitomycin) for intravesical solution in Phase 3 clinical development as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) at the upcoming 2022 American Urological Association (AUA) Annual Meeting, May 13-16 in New Orleans, Louisiana (Press release, UroGen Pharma, MAY 13, 2022, View Source [SID1234614523]). The presentations will be published in the June 2022 issue of The Journal of Urology and will be accessible via the AUA website.

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Details on AUA Presentations:

Podium Presentation
Abstract #: PD26-08
Session: Low-grade urothelial carcinoma recurs at a tempo that naturally accelerates from Adagio to Allegro
Presenter: Alex Sankin, M.D., Associate Professor Department of Urology, Albert Einstein College of Medicine
Date and Time: Saturday, May 14, 2022 at 2:10-2:20 PM CT
Location: Room 252

ICU Theater
Session: Chemoablation as primary treatment: Transforming the paradigm for low grade UTUC with JELMYTO
Presenter: Jennifer Linehan, M.D. Associate Professor of Urology and Urologic Oncology at the Saint John’s Cancer Institute
Date and Time: Sunday, May 15, 2022 at 12:00-1:00 PM CT
Location: S&T Hall: Booth 1043

Moderated Poster
Abstract #: MP54-06
Session: Longitudinal Health-Related Quality of Life Outcomes in Adults with Non-Muscle-Invasive Bladder Cancer Receiving a Chemoablative Gel as a Primary Treatment (Optima II: Phase 2b, single arm, open-label trial)
Presenter: Angela Smith, M.D., M.S. Associate Professor at the University of North Carolina (UNC) Department of Urology in Chapel Hill, North Carolina
Date and Time: Monday, May 16, 2022 at 8:45-10:00 AM CT
Location: Room 228

Podium Presentation
Abstract #: PD58-06
Session: Antegrade Administration of Reverse Thermal Mitomycin Gel for Primary Chemoablation of Upper Tract Urothelial Carcinoma via Percutaneous Nephrostomy Tube: a Multi-Institutional Real-World Experience
Presenter: Kyle Rose, M.D., Urologic Oncology Fellow at Moffitt Cancer Center in Tampa, Fla.
Date and Time: Monday, May 16, 2022 at 1:50-2:00 PM CT
Location: Room 252

UroGen will be hosting Booth #837 at the Ernest N. Morial Convention Center during AUA 2022.

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 U.S. Food and Drug Administration. 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.

On May 13, 2022 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its first quarter ended March 31, 2022 (Press release, HCW Biologics, MAY 13, 2022, View Source [SID1234614522]).

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"We continue to successfully execute our clinical development strategy which is based on our unique approach toward inflammaging," stated Hing C. Wong, Founder and CEO of HCW Biologics Inc. "HCW Biologics is developing immunotherapeutics that do not treat a single indication or symptom. Our approach is to treat a patient systemically to remove the underlying problems causing a condition."

Dr. Wong continued, "Our plan is to use difficult-to-treat cancer indications as the gateway for clinical development of our lead product candidate, HCW9218. In preclinical studies, we have demonstrated that HCW9218 can effectively reduce therapy-induced cancer and normal tissue cellular senescence to augment the anti-tumor activities of chemotherapies and alleviate their side effects. In addition, HCW9218 has been shown to significantly enhance anti-tumor activity of immune checkpoint therapies in a preclinical setting."

Dr. Wong further stated, "We believe that HCW9218 also has potential as a treatment for a broad range of age-related pathologies beyond cancer, through our discovery that HCW9218 can reduce accumulated senescent cells due to the naturally aging process or metabolic dysfunction, leading to the improvement of health span of experimental animals."

Business Highlights:

At the 105th Annual Meeting of the American Association of Immunologists held on May 6 -10, 2022, HCW Biologics showcased two novel groups of fusion molecules invented with the Company’s proprietary and versatile TOBI discovery platform. Two posters were presented which are available on the Company’s website:

A "kick and expand" strategy to generate large numbers of CIML NK cells for adoptive cell therapy for the treatment of cancer using novel fusion proteins HCW9201 and HCW9206.

Robust human regulatory T cell expansion with fusion proteins HCW9302 and HCW9213 circumvents need for magnetic-bead or feeder cell approaches for adoptive cell therapy.

On April 19, 2022, Dr. Hing Wong presented, "Bifunctional Immunotherapeutic HCW9218 for Cancer and Inflammaging," at the Third Annual International Conference on Cell and Experimental Biology. Dr. Wong presented preclinical data for the first time that showed results of the Company’s investigational work related to the treatment of inflammaging indications in naturally-aged mice. The Company believes these results demonstrate the potential of HCW9218 to fundamentally change the treatment of a broad range of diseases and conditions associated with aging, even aging itself, by enhancing health span that has been diminished with aging.

First Quarter 2022 Financial Results:

Cash and cash equivalents: On March 31, 2022, the Company’s cash balance was $18.1 million, short-term investments were $17.0 million and long-term investments were $9.8 million. Investments are all U.S. Treasury bills or notes. The Company estimates that the current cash balance is sufficient to fund operations through the end of 2023.

Revenues: Revenues were $3.1 million for the three-month period ended March 31, 2022, and there were no revenues in the three-month period ended March 31, 2021. Revenues were derived from the sale of clinical development material to our licensee, Wugen.

Research and development (R&D) expenses: R&D expenses were $1.8 million for the three-month period ended March 31, 2022, as compared to $2.3 million for the three-month period ended March 31, 2021. The 22% decrease in R&D expenses was driven primarily by a decrease in manufacturing and materials expenses and preclinical expenses.

General and administrative expenses (G&A): G&A expenses were $1.9 million for the three-month period ended March 31, 2022, as compared to $1.1 million for the three-month period ended March 31, 2021. The 73% increase reflects higher salaries, benefits and related expenses as a result of stock-based compensation expense associated with an equity award to the Company’s CEO upon completion of the Company’s IPO and an increase for Board compensation under our non-employee director compensation program, with a partial offset resulting from a decrease in performance-related bonuses.

Net loss: Net loss was $2.1 million for the three-month period ended March 31, 2022, compared to $2.8 million for the three-month period ended March 31, 2021.

On May 13, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended March 31, 2022 (Press release, Soligenix, MAY 13, 2022, View Source [SID1234614521]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We remain focused on our significant upcoming milestones for 2022. We anticipate submitting a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing authorization of HyBryte (SGX301 or synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) in the second half of this year. We expect to initiate a Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) in the second half of this year as well. With approximately $22.9 million in cash, not including our non-dilutive government funding, we anticipate having the capital required to achieve our near-term milestones, including NDA filing and expansion into psoriasis with the initiation of the Phase 2a clinical study."

Dr. Schaber continued, "Supported by funding from the National Institute of Allergy and Infectious Diseases, our Public Health Solutions business segment continues to achieve key objectives with our heat stable vaccine platform technology, ThermoVax. Recently, we announced results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in non-human primates (NHPs) demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. As always, we continue to evaluate various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On April 19, 2022, the Company announced it had received approximately $1.4 million, net of transaction costs, in non-dilutive funding via multiple government tax programs. To view this press release, please click here.
On March 17, 2022, the Company announced the results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in NHPs demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. To view this press release, please click here.
Financial Results – Year Ended March 31, 2022

Soligenix’s revenues for the quarter ended March 31, 2022 were $0.2 million as compared to $0.1 million for the quarter ended March 31, 2021. Revenues primarily included payments on government contracts and grants received to support the development of: RiVax, our ricin toxin vaccine candidate; SGX943, for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization platform technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $4.3 million, or ($0.10) per share, for the quarter ended March 31, 2022, as compared to $2.4 million, or ($0.06) per share, for the quarter ended March 31, 2021. The increase in net loss was primarily attributed to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries as well as an increase in research and development expenses associated with preparation of the upcoming HyBryte NDA filing.

Research and development expenses were $1.7 million as compared to $1.3 million for the quarter ended March 31, 2022 and 2021, respectively. The increase in research and development spending for the quarter ended March 31, 2022 was primarily attributable to the increased expenses associated with preparation of the upcoming HyBryte NDA filing.

General and administrative expenses were $2.6 million and $1.0 million for the quarter ended March 31, 2022 and 2021, respectively. This increase in general and administrative expenses is primarily attributable to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries.

As of March 31, 2022, the Company’s cash position was approximately $22.9 million.

On May 13, 2022 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2022 (Press release, Leap Therapeutics, MAY 13, 2022, View Source [SID1234614520]).

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Leap Highlights:

Presented positive new data from the DisTinGuish Study of DKN-01 plus BeiGene’s anti-PD-1 antibody tislelizumab and chemotherapy in gastroesophageal junction/gastric (GEJ/G) cancer patients at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium

Completed enrollment in Part B of the DisTinGuish Study evaluating DKN-01 plus tislelizumab in second-line GEJ/G cancer patients whose tumors express high levels of DKK1 (DKK1-high)

Entered partnership on DKK1 companion diagnostic with Leica Biosystems

Presenting initial data from the investigator-sponsored Phase 1b/2a clinical trial of DKN-01 in prostate cancer at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting
"We are making consistent progress in advancing DKN-01 across multiple tumor types and look forward to Dr. David Wise of New York University presenting initial prostate cancer data at the upcoming ASCO (Free ASCO Whitepaper) conference," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "With compelling response and survival data for DKN-01 in combination with BeiGene’s tislelizumab in gastric cancer patients presented in January, and the recent completion of enrollment in our second-line cohort, we are preparing for updated data readouts from our DisTinGuish study in the second half of the year. We are also looking forward to hosting an R&D Day in late June to outline the next phase in the clinical development strategy for DKN-01."

DKN-01 Development Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the DKK1 protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

Positive New Data from the DisTinGuish Clinical Trial (NCT04363801) of DKN-01 Plus Tislelizumab and Chemotherapy Presented at the ASCO (Free ASCO Whitepaper) GI Cancer Symposium. In January 2022, the Company presented positive new progression-free survival (PFS) and overall response data from Part A, the first-line cohort of the Phase 2a study in patients with gastroesophageal junction or gastric (GEJ/G) cancer, and initial findings from Part B of the clinical trial, studying DKN-01 and tislelizumab in second-line advanced GEJ/G cancer patients with high tumoral DKK1 expression.

Part A First-Line Patients: Of the 25 first-line patients who received a full cycle of DKN-01 therapy, overall response rate (ORR) was 68.2%, with 90% ORR in DKK1-high patients (9 partial responses (PR)) and 56% in DKK1-low patients (1 complete response, 4 PR). Among those patients with low PD-L1 expression ORR was 79% (with 100% ORR in DKK1-high patients and 57% ORR in DKK1-low patients), and in patients with higher PD-L1 expression ORR was 67% (with 75% ORR in DKK1-high patients and 50% in DKK1-low patients). The preliminary median PFS was 10.7 months in the overall first-line population, and median overall survival had not been reached. The Company expects to present updated survival data from the study in the second half of 2022.

Part B Second-Line Patients: Of the 30 second line DKK1-high GEJ/G cancer patients who received a full cycle of DKN-01 therapy and were response evaluable, ORR was 25%, with an additional patient who experienced an irPR by iRECIST criteria.

Completed Enrollment in the DisTinGuish Clinical Trial (NCT04363801) of DKN-01 Plus Tislelizumab in DKK1-high Second Line GEJ/G Cancer Patients. In May 2022, the Company completed enrollment in Part B of the DisTinGuish clinical trial, studying DKN-01 and tislelizumab in second-line advanced GEJ/G cancer patients with high tumoral DKK1 expression.

Entered Partnership on Companion Diagnostic with Leica Biosystems to Advance Care for Cancer Patients. In January 2022, Leap and Leica Biosystems, a cancer diagnostics company, entered into an agreement to develop a companion diagnostic to detect DKK1 in patient tumor biopsies. The assay developed by Leica will utilize RNAscope technology on the BOND-III Automated Staining System, which allows for detection of DKK1 with high sensitivity and specificity to help identify patients for DKN-01 treatment.

Abstract Accepted for Poster Presentation at the Upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Highlighting Initial Clinical Data from the Phase 1b/2a Clinical Trial (NCT03837353) of DKN-01 Plus Docetaxel in Prostate Cancer. The Company will present initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer at the upcoming 2022 ASCO (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL on June 3-7. Dr. David Wise of NYU Langone Medical Center is the lead investigator on the study.
Selected First Quarter 2022 Financial Results

Net Loss was $10.4 million for the first quarter 2022, compared to $9.1 million for the same period in 2021. The increase was primarily due to an increase in clinical trial costs due to the timing of patient enrollment and the duration of patients on study in the DisTinGuish trial and an increase in the number of research and development employees to support the development of DKN-01.

License revenues were $0.4 million for the first quarter 2021 and relate to the agreement with BeiGene for the development and commercialization of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. There were no license revenues recognized in the first quarter 2022, as the upfront payment was fully recognized as of December 31, 2021.

Research and development expenses were $7.8 million for the first quarter 2022, compared to $6.8 million for the same period in 2021. The increase in research and development expenses was due to an increase of $0.6 million in clinical trial costs due to timing of patient enrollment in the DisTinGuish study, an increase of $0.6 million in payroll and other related expenses, and an increase of $0.2 million in stock based compensation expense during the three months ended March 31, 2022. These increases were partially offset by a $0.4 million decrease in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns.

General and administrative expenses were $2.8 million for the first quarter 2022, compared to $2.7 million for the same period in 2021. The increase in general and administrative expenses was due an increase of a $0.2 million in stock based compensation expense and an increase of $0.1 million in payroll and other related expenses during the three months ended March 31, 2022. These increases were partially offset by a $0.2 million decrease in professional fees.

Cash and cash equivalents totaled $103.2 million at March 31, 2022. Research and development incentive receivables totaled $1.3 million at March 31, 2022.