On August 12, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported its financial results for the second quarter of 2022 and provided a business update (Press release, Xenetic Biosciences, AUG 12, 2022, View Source [SID1234618262]).

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"The past quarter was marked by a shift in our focus and prioritization of our pipeline with the in-licensing of our DNase-based oncology platform. With this transaction, we now have a clear path toward a Phase 1 clinical study in pancreatic carcinoma and other advanced solid tumors, creating the potential for value driving regulatory and clinical milestones," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "As a demonstration of our commitment to advance this important program, we engaged Catalent, a preeminent contract development and manufacturing organization, to produce cGMP clinical supply for our planned Phase 1 study. We also entered into a research and development collaboration with Belgian Volition SARL, and we look forward to advancing this exploratory program to develop NETs-targeted adoptive cell therapies. We are focused on executing on our preclinical and clinical development plans and look forward to unlocking the full potential of this oncology platform."

DNase Oncology Platform:Targeting Neutrophil Extracellular Traps ("NETs") to improve cancer therapies with a focus on advancing systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and other locally advanced or metastatic solid tumors.

Program Highlights:

In April 2022, executed exclusive license and sublicense agreements with CLS Therapeutics to develop its interventional DNase-based oncology platform, which is designed to improve outcomes of existing treatments, including immunotherapies.
Advancing toward planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.
Systemic DNase program initially targeting multi-billion-dollar indications including pancreatic carcinoma.
DNase armored CAR T program focused on demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response of CAR T therapy against solid tumor indications.
In June 2022, entered into a manufacturing agreement with Catalent Pharma Solutions LLC, which will include cGMP manufacturing of Phase 1 clinical supply.
Subsequent to quarter end, entered into a collaboration agreement with Belgian Volition SARL to develop NETs-targeted adoptive cell therapies for the treatment of cancer.
XCART Platform Technology: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells.

Program Highlights:

Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlight:

Royalty payments of approximately $0.4 million were received in the three months ended June 30, 2022, representing an approximate 45% increase over the same period in 2021 as Takeda’s sublicensee continued its worldwide launch of the product.
Summary of Financial Results for Second Quarter 2022

Net loss for the quarter ended June 30, 2022 was approximately $2.7 million. Research and development ("R&D") expenses for the three months ended June 30, 2022 increased by approximately $1.6 million, or 296.1%, to approximately $2.1 million from approximately $0.5 million in the comparable quarter in 2021 due to in-process research and development ("IPR&D") expense of $1.3 million. During the three months ended June 30, 2022, the Company expensed $1.3 million of IPR&D associated with the Company’s licensing of the DNase platform. There was no similar expense in 2021. Excluding the $1.3 million of IPR&D expense from total R&D expense of $2.1 million, R&D expense for the three months ended June 30, 2022 increased by $0.3 million, or 47.3%, primarily due to increased spending related to our XCART platform technology program. General and administrative expenses for the three months ended June 30, 2022 increased by approximately $0.1 million, or 15.2%, to approximately $1.0 million from approximately $0.9 million in the comparable quarter in 2021. The increase was primarily due to an increase in legal costs related to the licensing of the DNase platform during the three months ended June 30, 2022 compared to the same period in 2021.

The Company ended the quarter with approximately $14.9 million of cash.

On August 12, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Ocuphire Pharma, AUG 12, 2022, View Source [SID1234618261]).

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"Ocuphire has continued to deliver in the second quarter of 2022 on execution as a highly-productive and capital efficient company, with continued success in late-stage clinical trials, multiple positive data presentations featured at medical meetings, and additional IP protection granted for both Nyxol and APX3330," said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma. "With the completion of the final clinical trials of Nyxol in reversal of mydriasis, we remain focused on a late 2022 NDA filing as we ramp up our pre-commercial activities and entertain discussions with commercial partners in preparation for the anticipated approval of Nyxol as the first and only dilation reversal drop in 2023. We look forward to reporting top-line results in the second half of this year from the Phase 2b trial of APX3330 in diabetic retinopathy (DR). The opportunity in retina has multi-billion dollar potential. We are well positioned to deliver on our upcoming late-stage clinical and regulatory milestones through the second half of 2022."

Dr. Jay Pepose, Ocuphire’s Chief Medical Advisor and Board Member added, "A disruptive catalyst later this year will be top-line results from the ongoing multi-center, randomized, double-masked, placebo-controlled Phase 2b ZETA-1 trial evaluating APX3330 in diabetic retinopathy. APX3330 is a novel oral therapy with a dual mechanism of action in validated pathways, decreasing both abnormal angiogenesis and inflammation. It has shown a favorable safety profile for a systemic oral drug in hundreds of patients in 11 prior clinical trials. More recently, masked safety data from 70% of the 103 enrolled patients who completed 24 weeks of treatment in ZETA-1 trial were presented in July confirming the favorable safety and tolerability profile seen in prior trials. If approved, APX3330 has the potential to be a convenient oral treatment for diabetic patients with non-proliferative diabetic retinopathy and other diabetes-related complications. This could represent a paradigm shift from observation and monitoring progression today to an early, non-injection treatment option."

Key Anticipated Future Milestones

Reversal of Mydriasis (RM): Planned New Drug Application (NDA) with the FDA for Nyxol in RM indication in late 2022, with potential launch as first dilation reversal drop in 2H 2023
Presbyopia: Plan to initiate VEGA-2 trial, the first of two Phase 3 registration trials intended to support the use of Nyxol alone and Nyxol with 0.4% low dose pilocarpine (LDP) in presbyopia, in 2H of 2022; if successful, the Company expects to file a supplemental NDA for Nyxol as a single-agent for presbyopia and a new NDA for the combination thereafter
Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Report top-line results from the APX3330 Phase 2b ZETA-1 trial in 2H 2022
Second Quarter and Recent Business Highlights

Clinical Development

In April, the Company announced positive results from the MIRA-4 Phase 3 pediatric study in subjects aged 3-12 years, the final clinical trial supporting a planned NDA submission with for Nyxol in RM. The study met its primary safety endpoint, demonstrating a favorable safety and tolerability profile with no adverse events reported with similar efficacy seen in adults.
In May, the Company announced positive top-line results from the LYNX-1 Phase 3 trial evaluating Nyxol for Night Vision Disturbance (NVD). The study met the FDA-agreed upon primary endpoint with statistically significantly more Nyxol-treated subjects having gained 15 or more letters of mesopic low contrast distance visual acuity compared to placebo. Key secondary efficacy endpoints were also met with statistical significance, and Nyxol showed a favorable safety and tolerability profile with no serious adverse events reported. This is the first Phase 3 trial to study NVD and to show an improvement in distance and contrast vision at night with a pupil modulation mechanism which has cross-over safety differentiation to presbyopia. The Phase 3 protocol for VEGA-2 was submitted to the FDA in July.
In June, the Company held a Type B Pre-NDA meeting with the FDA at which it received guidance on the content of CMC, clinical and non-clinical modules of the planned NDA for Nyxol in RM. The FDA confirmed that OraVerse and Regitine were appropriate to use as reference listed drugs to support a 505(b)(2) NDA.
Presentations, Publications, and Conferences

From April through August 2022, Ocuphire was represented at conferences by Mina Sooch and several prominent key thought leaders, including David Boyer, MD, Peter Kaiser, MD, David Lally, MD, and Michael Allingham, MD, PhD who presented updates on APX3330 in DR, as well as Jay Pepose, MD, PhD, Marguerite McDonald, MD, Inder Paul Singh, MD, Ralph Chu, MD, James Katz, MD and Douglas Devries, OD who presented data for Nyxol in Presbyopia and RM. Since the beginning of the year, 9 podium papers, 5 posters, and over 10 panel or company talks were presented across a total of 20 medical, scientific, industry and investment conferences.
In June at the 45th Annual Macula Society Meeting in Germany and in July at the American Society of Retina Specialists (ASRS) 2022 in New York, David Boyer, MD and David Lally MD, presented updated masked safety data from the ongoing ZETA-1 Phase 2b trial evaluating APX3330. The latest data from mid-June represented 100% of 103 subjects having completed 12 weeks or more and 70% having completed 24 weeks. These safety data are consistent with favorable safety profile from the prior 11 clinical trials with total exposure experience of over 9,000 subject-days with a 600 mg daily dose of APX3330.
In July, at the 40th Annual Meeting of ASRS, David Boyer, MD, presented for the first time to the retina medical community a late-breaking paper highlighting positive data from the MIRA-2 and MIRA-3 Phase 3 registration trials for Nyxol eye drops to rapidly reverse mydriasis.
In July, the Company announced the publication of a preclinical study supporting the novel mechanism of action inhibiting NFkB and the inflammatory pathway for APX3330 and APX pipeline candidates. The publication, titled "RelA is an Essential Target for Enhancing Cellular Responses to the DNA Repair/Ref-1 Redox Signaling Protein and Restoring Perturbated Cellular Redox Homeostasis in Mouse PDAC Cells" was published in Frontiers in Oncology and can be accessed here.
Corporate

In April, Ocuphire appointed Jay Pepose, MD, PhD, as Chief Medical Advisor in addition to his Board of Directors role.

Ocuphire was granted two new patents covering APX3330 and Nyxol:
APX3330 for Use in Diabetics: U.S. Patent No. 11,351,130 with claims to methods of treating inflammation and chronic pain in subjects suffering from diabetes using APX3330 was issued on June 7, 2022 with expiry in 2038.
Nyxol for Reversal of Mydriasis: U.S. Patent No. 11,400,077 with claims directed to methods for mydriasis treatment using phentolamine was issued on August 2, 2022 with expiry in 2039.
Second Quarter Ended June 30, 2022 Financial Highlights

As of June 30, 2022, Ocuphire had cash and cash equivalents of approximately $17.0 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations through the third quarter of 2023. Net cash used in operating activities in the second quarter of 2022 was $3.8 million, with a cumulative total for the six months ended June 30, 2022 of $10.0 million.

General and administrative expenses for the three and six months ended June 30, 2022, were $1.8 million and $3.5 million, respectively, compared to $3.4 million and $5.million, respectively, for the three and six months ended June 30, 2021.

Research and development expenses for the three and six months ended June 30, 2022, were $3.2 million and $7.9 million, respectively, compared to $3.8 million and $7.3 million, respectively, for the three and six months ended June 30, 2021. The decrease from the comparable second quarter in 2021 was primarily attributable to the completion of clinical trials and the timing manufacturing activities for Nyxol and APX3330. The increase from the comparable six-month period in 2021 was primarily attributable to more ongoing clinical trials and manufacturing activities for Nyxol and APX3330 as well as regulatory, preclinical and other development activities.

The total loss from operations for the three and six months ended June 30, 2022, was $4.9 million and $11.4 million, respectively, compared to $7.1 million and $12.3 million, respectively, for the three and six months ended June 30, 2021.

Net loss for the three and six months ended June 30, 2022, was $4.9 million and $11.5 million, respectively, compared to $7.1 million and $46.2 million, respectively, for the three and six months ended June 30, 2021. Net loss per share for the three and six months ended June 30, 2022, was ($0.25) and ($0.60) per share, respectively, compared to ($0.52) and ($3.76) per share, respectively, for the comparable periods in 2021.

For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 to be filed with the Securities and Exchange Commission.

On August 12, 2022 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its second quarter ended June 30, 2022 (Press release, HCW Biologics, AUG 12, 2022, View Source [SID1234618260]).

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"We have achieved several milestones in the first half of 2022, and some important pieces of our strategic plan have fallen into place. First, we are now a clinical-stage company, with the entry of our lead product candidate, HCW9218, into the clinic in a solid tumor cancer trial. Our pancreatic study is not far behind, and we expect to initiate this clinical trial in the third quarter. Next, we have produced promising data in preclinical studies for our lead product candidate, HCW9302, in the treatment of proinflammatory diseases driven by activated inflammasomes. We used this data as a basis for a pivotal scientific paper for HCW9302 that we expect to be published in a high-impact, peer-reviewed journal by the end of the year," stated Hing C. Wong, Ph.D., Founder and CEO of the Company.

Dr. Wong continued, "By working with preeminent National Cancer Institute designated Comprehensive Cancer Centers, it appears that we have mitigated some of the risk for maintaining our expected rate of patient enrollment. At our current pace, we expect to be in a position to provide an early human-experience data readout from the clinical trials for HCW9218 by the end of 2022. While it is very early, we are encouraged by how patients are responding to HCW9218."

Dr. Wong reported, "HCW Biologics has advanced one of our key strategic initiatives – establishing our own domestic manufacturing capability. We have committed to purchase a 36,000 square foot building in Miramar, Florida that will be the new headquarters for our offices, research labs, and manufacturing facility. To buildout our new facilities, our team will leverage their past experience in constructing similar facilities. We expect to complete the project by the end of 2023, and to move into our new facility shortly thereafter. Currently, contract manufacturers are experiencing backlogs of up to two years. With our own manufacturing facility, we believe we will have better control over our supply chain as we advance to later-stage clinical trials requiring additional clinical materials, as well as fulfilling our obligations to our licensee, Wugen."

Business Highlights:

On May 19, 2022, the Masonic Cancer Center, University of Minnesota, announced that they opened a new Phase 1 solid tumor cancer clinical trial and treated their first patient with HCW9218, an injectable, bifunctional immunotherapeutic, developed by HCW Biologics Inc. This Phase 1, first-in-human clinical trial is enrolling patients that have advanced solid tumors with progressive disease after prior chemotherapies.
On August 2, 2022, HCW Biologics was granted U.S. Patent No. 11,401,324 which contains claims for immunotherapeutic compounds comprised of a single-chain chimeric polypeptide with two target-binding domains on a scaffold made of an extracellular domain of human tissue factor. This patent provides protection for the underlying intellectual property on which the Company has based its lead product candidate, HCW9302. The issuance of the Company’s first patent with such broad claims marks an important step in the evolution of its patent portfolio.
On August 10, 2022, HCW Biologics committed to purchase a building located in Miramar, Florida for approximately $10.0 million, as the Company’s new headquarters. The Company received a commitment for a five-year term facility to finance the purchase, expansion, and improvement of the new property. An initial takedown equal to 65% of the purchase price will be funded on the closing date which is expected to be on August 15, 2022. The term facility may be increased to provide additional funding for expansion and improvements of the property; however, future borrowings will be subject to full credit approval and due diligence by the lender.
Second Quarter 2022 Financial Results:

Cash and cash equivalents: On June 30, 2022, the Company’s cash balance was $42.1 million, consisting of $15.4 million in cash and cash equivalents, $17.0 million in short-term investments, and $9.7 million in long-term investments. Investments are all U.S. Treasury bills or notes. The Company estimates that the current cash balance, along with a commitment for a term facility for the purchase of the Company’s new headquarters, is sufficient to fund operations and capital expenditures through the end of 2023.
Revenues: Revenues were $454,000 for the three-month period ended June 30, 2022, and there were no revenues in the three-month period ended June 30, 2021. Revenues were $3.6 million for the six-month period ended June 30, 2022, and there were no revenues in the six-month period ended June 30, 2021. Revenues were derived exclusively from the sale of clinical development material to our licensee, Wugen.
Research and development (R&D) expenses: R&D expenses were $1.7 million for the three-month period ended June 30, 2021, as compared to $2.0 million for the three-month period ended June 30, 2022, an 18% increase, due primarily to an increase in preclinical expenses. R&D expenses were $4.0 million for the six-month period ended June 30, 2021, as compared to $3.8 million for the six-month period ended June 30, 2022, a 5% decrease, due primarily to a decrease in manufacturing and materials expenses partially offset by an increase in preclinical expenses.
General and administrative (G&A) expenses: G&A expenses were $1.1 million for the three-month period ended June 30, 2021, as compared to $1.7 million for the three-month period ended June 30, 2022, a 55% increase. G&A expenses were $2.2 million for the six-month period ended June 30, 2021, as compared to $3.6 million for the six-month period ended June 30, 2022, a 64% increase. These increases reflect 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, an increase for Board compensation under our non-employee director compensation program, and an increase in insurance costs and other expenses related to operating as a public company.
Net loss: Net loss was $2.8 million for the three-month period ended June 30, 2021, compared to $3.5 million for the three-month period ended June 30, 2022. Net loss was $5.6 million for in each of the six-month periods ended June 30, 2021 and June 30, 2022. Net loss for the six-month period ended June 30, 2021 included the impact of forgiveness of the Company’s PPP loan. Net loss for the six-month period ended June 30, 2022 included the impact of unrealized loss on investments resulting from changes in interest rates.

On August 12, 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 June 30, 2022 (Press release, Soligenix, AUG 12, 2022, View Source [SID1234618259]).

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"We have accomplished a number of important milestones thus far in 2022, with more significant milestones anticipated before year-end," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Under our Specialized Biotherapeutics business segment, the results of our successful Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating HyBryte (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) were published in the prestigious JAMA Dermatology. We received agreement from the U.S. Food & Drug Administration (FDA) on an initial pediatric study plan for HyBryte which stipulates our intention to request a full waiver of pediatric studies upon submission of the HyBryte new drug application (NDA) in the fourth quarter of this year. Additionally, we are expanding into new disease indications with synthetic hypericin (SGX302) having received FDA investigational new drug (IND) clearance for a Phase 2a clinical trial in mild-to-moderate psoriasis, also expected to begin in the fourth quarter of this year.

Our Public Health Solutions business segment, supported by funding from the National Institute of Allergy and Infectious Diseases, continues to achieve key objectives that have the potential to play an important role in the Biden-Harris Administration’s initiatives for pandemic preparedness. Recently, we demonstrated 100% protection of non-human primates against both lethal Sudan ebolavirus and Marburg marburgvirus challenge using a bivalent, thermostabilized vaccine formulated in a single vial. This same heat stable subunit vaccine platform technology has been applied to the development of our COVID-19 vaccine, CiVax, which has demonstrated rapid and broadly functional vaccine and booster responses, including against delta and omicron variants. We also entered into a strategic partnership with SERB Pharmaceuticals to supply our novel ricin antigen in support of their early stage ricin therapeutic development program."

Dr. Schaber continued, "With approximately $20.2 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 initiation of the Phase 2a psoriasis study, while we continue to evaluate various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments
On July 27, 2022, the Company announced it had received agreement from the FDA on an initial pediatric study plan for HyBryte for the treatment of CTCL. To view this press release, please click here.

On July 25, 2022, the Company announced it had signed a worldwide exclusive license to supply its ricin antigen to SERB Pharmaceuticals, for development of a novel therapeutic treatment against ricin toxin poisoning. To view this press release, please click here.

On July 20, 2022, the Company announced that the results of its successful Phase 3 FLASH study evaluating HyBryte for the treatment of CTCL has been published in the Journal of the American Medical Association (JAMA) Dermatology. To view this press release, please click here.

On June 28, 2022, the Company announced that the FDA had cleared the IND application for its Phase 2a clinical trial titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." To view this press release, please click here.

On June 23, 2022, the Company announced it had achieved 100% protection of non-human primates against lethal Marburg marburgvirus challenge using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with sterile water immediately prior to use. To view this press release, please click here.

On June 1, 2022, the Company announced a publication describing key binding characteristics of its Innate Defense Regulator, dusquetide, to the p62 protein. To view this press release, please click here.

On May 23, 2022, the Company announced the United States Patent and Trademark Office had issued a Notice of Allowance for the patent application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines." To view this press release, please click here.
Financial Results – Year Ended June 30, 2022
Soligenix’s revenues for the quarter ended June 30, 2022 were $0.4 million as compared to $0.2 million for the quarter ended June 30, 2021. Revenues primarily included licensing revenue from the Company’s strategic partnership with SERB Pharmaceuticals and payments on government contracts and grants. The Company has received government funding to support the development of: RiVax, its ricin toxin vaccine candidate; SGX943, for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, its thermostabilization platform technology; and CiVax, its vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $2.4 million, or ($0.06) per share, for the quarter ended June 30, 2022, as compared to $1.9 million, or ($0.05) per share, for the three months ended June 30, 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 $2.0 million as compared to $1.9 million for the quarter ended June 30, 2022 and 2021, respectively. The increase in research and development spending for the quarter ended June 30, 2022 was primarily attributable to the increased expenses associated with preparation of the upcoming HyBryte NDA filing.

General and administrative expenses were $1.4 million and $1.1 million for the quarter ended June 30, 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 June 30, 2022, the Company’s cash position was approximately $20.2 million.

On August 12, 2022 Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the second quarter ended June 30, 2022 (Press release, Leap Therapeutics, AUG 12, 2022, View Source [SID1234618258]).

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Leap Highlights:

Initiation of Part C of the ongoing DisTinGuish study to evaluate DKN-01, Leap’s anti-Dickkopf 1 (DKK1) antibody, in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy compared to a tislelizumab and chemotherapy control arm, in patients with gastric or gastroesophageal junction cancer (G/GEJ)

Initiation of a new company-sponsored trial of DKN-01 in combination with standard of care bevacizumab and chemotherapy in second-line patients with colorectal cancer (CRC)

Supporting an investigator-initiated trial of DKN-01 plus pembrolizumab in patients with endometrial cancer to be conducted at The University of Texas M.D. Anderson Cancer Center and at the University of Alabama at Birmingham

Presented initial clinical data from an investigator-sponsored Phase 1b/2a dose escalation and dose expansion study of DKN-01 as a monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer (mCRPC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Cash and cash equivalents totaled $90.9 million at June 30, 2022, expected to provide financial runway to mid-2024
"The Company has made important steps during the second quarter to expand the development of DKN-01 with the initiation of a randomized controlled clinical trial in combination with BeiGene’s tislelizumab and chemotherapy in first-line G/GEJ cancer patients. The results to date from Part A and B of our DisTinGuish study have been compelling, and we look forward to further data readouts in the second half of the year," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We are also excited to initiate a company-sponsored study in second-line colorectal cancer patients and to support an investigator-initiated study with Merck’s anti-PD-1 antibody pembrolizumab in endometrial cancer patients, as part of a broad strategy for the global development of 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.

Leap and BeiGene Announced Initiation of Part C of the Ongoing DisTinGuish Study to Evaluate DKN-01, in Combination with Tislelizumab and Chemotherapy Compared to a Tislelizumab and Chemotherapy Control Arm, in Patients with G/GEJ. The DisTinGuish study (NCT04363801) is a Phase 2 study of DKN-01 in combination with tislelizumab and standard of care (SOC) chemotherapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. Part C of the DisTinGuish study will enroll approximately 160 first-line, HER2-negative patients who have had no prior therapy for unresectable locally advanced or metastatic G/GEJ adenocarcinoma. Patients will be randomized 1:1 to study DKN-01 in combination with tislelizumab and SOC chemotherapy, compared to tislelizumab and SOC chemotherapy. The primary objective of Part C is progression-free survival (PFS) in patients whose tumors express high levels of DKK1 (DKK1-high). Secondary objectives of Part C include PFS in all patients regardless of DKK1 expression, as well as overall survival (OS) and objective response rate (ORR) as measured by RECIST v1.1 in DKK1-high and all patients.

Leap Announced Initiation of the DeFiance Study of DKN-01 in Combination with SOC Bevacizumab and Chemotherapy in Second-line Patients with CRC. The DeFianCe study (NCT05480306) is a Phase 2 study of DKN-01 in combination with bevacizumab and SOC chemotherapy in patients with advanced CRC who have received one prior systemic therapy. The study is designed with an initial 20 patient cohort and to then expand into a 130 patient randomized controlled trial against bevacizumab and SOC chemotherapy. The primary objective is PFS. Secondary objectives include ORR, duration of response (DOR), and OS.

Leap Announced the Support of an Investigator-initiated Trial of DKN-01 Plus Pembrolizumab in Patients with Endometrial Cancer to be Conducted at The University of Texas M.D. Anderson Cancer Center and at the University of Alabama at Birmingham. The investigator-initiated trial of DKN-01 in combination with pembrolizumab is an open-label, Bayesian design, Phase 2 trial and will initially enroll 15 patients each into DKK1-high and DKK1-low cohorts. If the efficacy criteria is met in either or both of the 15 patient cohort(s), then the cohort(s) will be expanded by an additional 15 patients. The primary objective of the study is ORR. Secondary objectives include clinical benefit rate (CBR), PFS, OS, and DOR.

Leap Presented Initial Clinical Data from the Investigator-Sponsored Study of DKN-01 Plus Docetaxel in Patients with Prostate Cancer at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. In May 2022, the Company presented 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 mCRPC. Highlights from the data include:
No DLTs were observed at DKN-01 300mg or 600mg dose levels as monotherapy or in combination with docetaxel, and no treatment-related adverse events occurred in either cohort
No partial responses (PR) were seen in the monotherapy cohort with best overall response of stable disease in 2 out of 5 evaluable patients
In the combination cohort, all 6 patients had a greater than 50% reduction in PSA levels (PSA50), and the 5 patients with measurable disease each had a PR by RECIST (3 confirmed, 2 unconfirmed)
Confirmed partial responses in the combination cohort were observed in both DKK1 high and low expressing tumors, including in 2 out of 3 patients with aggressive variant prostate cancer
Selected Second Quarter 2022 Financial Results

Net Loss was $17.0 million for the second quarter 2022, compared to $9.5 million for the same period in 2021. The increase was primarily due to an increase in manufacturing costs related to clinical trial material, an increase in clinical trial costs due to 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.

Research and development expenses were $14.0 million for the three months ended June 30, 2022, compared to $7.2 million for the three months ended June 30, 2021. The increase in research and development expenses was due to an increase of $5.2 million in manufacturing costs related to clinical trial material and manufacturing campaigns, an increase of $1.2 million in clinical trial costs due to patient enrollment and duration of patients on study, an increase of $0.4 million in payroll and other related expenses due to an increase in headcount of our research and development full time employees, and an increase of $0.2 million in stock based compensation expense due to new stock options and restricted stock units granted to research and development full time employees, offset by a decrease of $0.2 million in consulting fees.

General and administrative expenses were $2.9 million for the three months ended June 30, 2022, compared to $2.8 million for the three months ended June 30, 2021. The increase in general and administrative expenses was due to an increase of $0.1 million in stock based compensation expense due to new stock options and restricted stock units granted to general and administrative full time employees.

Cash and cash equivalents totaled $90.9 million at June 30, 2022. Additionally, short-term research and development incentive receivable totaled $1.1 million.