On September 13, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the Company will be presenting initial data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held virtually on September 16-21, 2021 (Press release, Leap Therapeutics, SEP 13, 2021, View Source [SID1234587588]). The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

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"Initial data from the DisTinGuish study is extremely promising as it shows DKN-01 in combination with tislelizumab and chemotherapy to have high response rates in first-line patients suffering from gastric and gastroesophageal junction cancer," said Cynthia Sirard, MD, Chief Medical Officer of Leap. "Patients whose tumors have high levels of DKK1 expression, which is known to correlate with aggressive disease and poor prognosis, showed the highest response rates, suggesting how important the biomarker may be in predicting response to therapy. Additional data will be presented at ESMO (Free ESMO Whitepaper) and in our conference call to demonstrate the potential DKN-01 has as part of first-line therapy in this difficult-to-treat indication."

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts, in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Key Findings

DKN-01 in combination with tislelizumab and chemotherapy demonstrated compelling overall response rates (ORR) as a first-line treatment for advanced G/GEJ cancer
In the primary efficacy analysis, including all patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients as compared to a 56% ORR in DKK1-low patients
In the overall intent to treat population, including those patients who did not receive a full cycle of therapy, the ORR was 60%, with 75% ORR in DKK1-high patients as compared to a 56% ORR in DKK1-low patients
As of the date of the abstract, 13 patients had experienced a partial response (PR), six patients had a best response of stable disease (SD), one patient was non-evaluable for response (NE), three patients were unable to complete a full cycle of therapy (non-modified ITT (mITT)), and two patients were pending their first tumor assessment. Of the 18 patients that had RNAscope DKK1 expression available for the abstract, 9 were DKK1-high [6 PR, 1 NE, and 2 non-mITT] and 9 were DKK1-low [5 PR, 4 SD]. Subsequent to the date of the abstract, the two patients who were pending their first scan for response to therapy were determined to have had PRs, and three additional patients were determined to have had DKK1-high tumors, each of whom experienced a PR.

Further results will be presented at the ESMO (Free ESMO Whitepaper) 2021 Congress from September 16 to 21, 2021.

Leap Presentation Details:

Title: DKN-01 in combination with tislelizumab and chemotherapy as a first-line therapy in unselected patients with advanced gastroesophageal adenocarcinoma (GEA): DisTinGuish Trial
Abstract Number: 2218
Session type: E-Poster Presentation
Presenter: Samuel J. Klempner, Harvard Medical School
Date and time: Thursday, September 16, 2021; 2:30 a.m. ET

Conference Call

Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data. In addition to Leap’s executive management team, Dr Jaffer Ajani of M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 1729397. The presentation will be webcast live and may be accessed on the Investors page of the Company’s website at View Source, where a replay of the event will also be available for a limited time.

On September 13, 2021 Champions Oncology, Inc. (Nasdaq:CSBR), leaders in transformative technology solutions utilized in drug discovery and development, reported its financial results for its first quarter of fiscal 2022, ended July 31, 2021 (Press release, Champions Oncology, SEP 13, 2021, View Source [SID1234587605]).

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First Quarter and Recent Highlights:

Record quarterly revenue of $11.3 million, an increase of 18% year over year
Reported non-GAAP income from operations, excluding stock-based compensation, depreciation and amortization, of $422,000
Validated 6 therapeutic discovery targets
Ronnie Morris, CEO of Champions, commented, "On our year-end earnings call, we outlined the transformative strategic vision for Champions with the expansion of our services to include a Software as a Service ("SaaS") business and therapeutic target discovery platform. During the first quarter, we continued executing that strategy as we added new users to our SaaS platform and by advancing our therapeutic targets through the development pipeline."

David Miller, CFO of Champions, added, "During Q1 2022, we hit another quarterly revenue record surpassing $11 million for the first time. Operating income excluding stock compensation and depreciation expenses exceeded $400,000 even as we ramped up our R&D investment to support our new strategic initiatives."

First Fiscal Quarter Financial Results

For the first quarter of fiscal 2022, revenue increased 17.9% to $11.3 million compared to $9.5 million for the first quarter of fiscal 2021. The increase in revenue was due to a continued increase in sales, both in number and size of studies, and the expansion of our platforms and business lines. Total costs and operating expenses for the first quarter of fiscal 2022 were $11.4 million compared to $9.5 million for the first quarter of fiscal 2021, an increase of $1.9 million or 20.0%.

For the first quarter of fiscal 2022, Champions reported a loss from operations of $175,000, including $280,000 in stock-based compensation and $317,000 in depreciation and amortization expenses, compared to income from operations of $24,000, inclusive of $120,000 in stock-based compensation and $277,000 in depreciation and amortization expenses, in the first quarter of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $422,000 for the first quarter of fiscal 2022 compared to non-GAAP income from operations of $421,000 in the first quarter of fiscal 2021.

Cost of oncology solutions was $5.4 million for the three-months ended July 31, 2021, an increase of $60,000, or 1.1% compared to $5.3 million for the three-months ended July 31, 2020. For the three- months ended July 31, 2021, gross margin was 52.0% compared to 44.1% for the three-months ended July 31, 2020. The nominal increase in cost of sales was primarily due to reducing our reliance on outsourcing lab work by performing the work internally. The associated cost reduction offset the increase in compensation and lab supply expenses resulting from the increase in study volume. The nominal increase in cost of sales on revenue growth of $1.7 million led to the improvement in gross margin.

Research and development expense for the three-months ended July 31, 2021 was $2.3 million, an increase of $707,000 or 44.3%, compared to $1.6 million for the three-months ended July 31, 2020. The increase was primarily from compensation and lab supplies as we increased investment in our therapeutic discovery platforms. Sales and marketing expense for the three-months ended July 31, 2021 was $1.6 million, an increase of $366,000, or 30.3%, compared to $1.2 million for the three-months ended July 31, 2020. The increase was primarily due to compensation expense driven by the continued investment in expanding our business development team, including the addition of a dedicated SaaS business development team for our Lumin Bioinformatics platform. General and administrative expense for the three-months ended July 31, 2021 was $2.2 million, an increase of $772,000, or 55.9%, compared to $1.4 million for the three-months ended July 31, 2020. The increase was primarily due to an increase in compensation, which included $123,000 of additional stock compensation expense, as well as an increase in IT related expenses and depreciation and amortization.

Net cash provided by operating activities was $216,000 for the three-months ended July 31, 2021.The cash generated from operating activities was primarily due to operating income excluding stock compensation, depreciation and amortization expenses.

The Company ended the quarter with a strong cash position of $4.0 million. The Company has no debt.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its first quarter financial results. To participate in the call, please call 844-602-0380 (domestic) or 862-298-0970 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available by Tuesday, September 14, 2021 in the Company’s Form 10-Q at www.championsoncology.com.

* Non-GAAP Financial Information

See the attached Reconciliation of GAAP net income (loss) to Non-GAAP net income for an explanation of the amounts excluded to arrive at Non-GAAP net income and related Non-GAAP earnings per share amounts for the three months ended July 31, 2021 and 2020. Non-GAAP financial measures provide investors and management with supplemental measures of operating performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income and Non-GAAP earnings per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings per share amounts as Non-GAAP net earnings divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings and Non-GAAP diluted earnings per share may differ from similarly named measures used by other companies.

On September 13, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that Management will participate in the upcoming investor events set out below (Press release, Transgene, SEP 13, 2021, View Source [SID1234587622]):

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– Investor Access Forum – Physical event (Paris, France)
September 27 & 28, 2021

– HealthTech Innovation Days 2021 – Digital & physical event (Paris, France)
October 4 & 5, 2021

-European Midcap Event – Digital & physical event (Paris, France)

October 21 & 22, 2021

– EigenKapitalForum – Digital event

November 22, 2021

-Investir Day – Physical event (Paris, France)

November 23, 2021

On September 13, 2021 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of the next generation minimally invasive cryoablation technology that destroys tumors by freezing, reported that the first peer reviewed article "Cryoablation Without Excision for Low-Risk, Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial" was published in the Annals of Surgical Oncology with Dr. Richard Fine, MD, FACS, an ICE3 investigator who serves as Program Director of the Breast Surgical Oncology Fellowship and as Director of Research and Education at the West Comprehensive Breast Center in Germantown, TN, as the lead author (Press release, IceCure Medical, SEP 13, 2021, View Source [SID1234587654]).

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"Having a peer reviewed publication of the ICE3 Clinical Study[1] interim results in a well-respected medical journal represents a major milestone for IceCure in solidifying the efficacy and adaptation of its minimally invasive solution by the broader medical community for the treatment of certain breast cancers," stated IceCure CEO, Eyal Shamir. The article reports the results previously announced on April 29, 2021 at the American Society of Breast Surgeons Annual Meeting, that at a mean of 34.83 months following treatment with ProSense Cryoablation System, only 2.06% (4 of 194 patients) experienced cancer recurrence.

The journal article concludes that "breast cryoablation presents a promising alternative to surgery while offering the benefits of a minimally-invasive procedure with minimal risks."[2] Study author Dr. Fine stated that "the 3-year ICE3 trial results highlighting the efficacy and safety of the procedure in this patient group are extremely promising for breast cryoablation. Being able to provide a minimally-invasive option for treating appropriate low risk patients represents a dramatic improvement in care – the procedure is quick, painless and can be delivered with local anesthesia in doctor’s office, with minimal recovery time and excellent cosmetic outcomes."

Dr. Richard Fine will be presenting his findings on cryoablation at the upcoming Mayo Clinic School of Continuous Professional Development Conference "Breast Cancer Care: Innovation, Disruptive Technologies and Early Adopters 2021" in Rochester, MN on Friday, September 17, 2021. Scott Peairs, IceCure US Commericial Director, will be on site at the exhibit.

On September 13, 2021 ITM AG, a leading radiopharmaceutical biotech company, reported that it has signed a strategic long-term agreement to create a Joint Venture with Chengdu Gaotong Isotope Co. Ltd., the leading provider of radiopharmaceuticals and nuclear services in China and a subsidiary of ITM’s collaboration partner China Isotope and Radiation Corporation (CIRC) (Press release, ITM Isotopen Technologien Munchen, SEP 13, 2021, View Source [SID1234587673]). The newly formed company is planned to start operations in Q4 2021 and will be located in Chengdu, China. It will focus its operations on the supply of ITM’s EndolucinBeta (n.c.a. 177Lu) and Gallium Generators to the rapidly emerging Chinese radiopharmaceutical industry. ITM hereby also increases its footprint in China with a second in country location after having established its first subsidiary in Shanghai earlier this year. The Joint Venture will be led by both companies with the goal of scaling and securing access to ITM’s state-of-the-art medical radioisotopes in China.

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"China is an important market for us and this Joint Venture represents our commitment to the region as well as our global efforts to bring a new generation of targeted radiopharmaceuticals to patients with hard-to-treat cancers worldwide," said Steffen Schuster, CEO of ITM. "We are committed to further expanding our successful, long-term partnership with CIRC and are looking forward to increasing our global footprint in China. Next to our own clinical development of targeted radiotherapeutics and diagnostics through our Chinese subsidiary, the new Joint Venture with Gaotong will also help facilitate market access and build new partnerships for our therapeutic radioisotope EndolucinBeta and our Gallium generators for precision oncology treatments with the growing Chinese radiopharmaceutical industry as a whole."

"The demand for innovative, precise and high-quality treatment options for cancer patients in China continues to increase. Together with ITM, we are working toward addressing this need," said Mr. Wang Suohui, the General Manager of CIRC. "We established a collaboration with ITM over ten years ago and strengthened our partnership in 2019 to locally manufacture and distribute ITM’s EndolucinBeta and Gallium Generators. We are excited to establish this Joint Venture as the next step in our common development and look forward to working with ITM in providing increasing quantities of high-quality medical radioisotopes to Chinese hospitals and industry and to further improving access for precise cancer radiotherapeutics and diagnostics for patients."

The Joint Venture follows the existing strategic partnership between ITM and CIRC which was initially formed in 2010 and further extended in November 2019. As part of the newly-formed Joint Venture, ITM and CIRC will also work on securing and scaling the supply of diagnostic and therapeutic radioisotopes as a robust basis for the clinical development and commercialization of targeted radiotherapeutics and diagnostics in China both independently and together with local pharmaceutical partners. Further details of the agreement were not disclosed.