On September 14, 2021 Nucleai, a leader in AI-powered spatial biology, and Jefferson Health, a leading cancer center, reported that they have entered into a strategic collaboration to discover spatial immunotherapy biomarkers, leveraging Nucleai’s ATOM platform and Jefferson’s repository of pathology and clinical data (Press release, Nucleai, SEP 14, 2021, View Source [SID1234587793]). The mutual collaboration will help advance AI-based solutions in discovering histological biomarkers and patient selection in clinical trials and clinical settings. The Israeli Innovation Authority supports the collaboration as part of the International Health-Tech Pilot Program.

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Nucleai’s ATOM platform analyzes pathology images using computer vision and machine learning methods to model the tumor and the immune system’s spatial characteristics, creating unique and specific histological biomarkers that may predict patient response to therapy. These biomarkers hold the potential to provide a better understanding of cancer biology, enable further stratification of responder/non-responder patient populations, and improve the success rate of clinical trials and patient care. Nucleai leverages proprietary multimodal datasets of pathology images and clinical data from leading hospitals and Health Maintenance Organizations (HMOs) in the U.S and Israel to develop its platform.

As part of the collaboration between Nucleai and Jefferson, the two parties will test the utility of AI-based predictive biomarkers in a real-world clinical setting and assess the clinical benefit that the novel platform could provide for cancer patients treated with immunotherapy.

"It is now clear that analysis of digital pathology through computational approaches opens access to "hidden" information that is beyond the resolution of a pathologist’s examination through a microscope. We look forward to working with Nucleai to "unlock" such information to learn new disease mechanisms and using it to help our patients," said Stephen Peiper, Peter A. Herbut Professor and Chair Department of Pathology, Anatomy and Cell Biology at Thomas Jefferson University and Senior Vice President for the Enterprise Pathology and Laboratory Medicine Service Line of Jefferson Health System.

"Jefferson is dedicated to providing the highest-quality, compassionate clinical care for patients, preparing tomorrow’s professional leaders for 21st century careers, and discovering new treatments to define the future of care. The collaboration with Nucleai epitomizes this vision," said Zvi Grunwald, the Director of the Jefferson Israel Center.

"We are thrilled to launch this collaboration with Jefferson Health and are honored to be included in the Israeli Innovation Authority pilot program. Nucleai brings a unique spatial biology perspective into precision medicine, and we are eager to apply our platform to support novel biomarker discovery, diagnostics development, and clinical decision support," Nucleai CEO Avi Veidman said in a statement.

On September 14, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported the outcome of the exercise of the warrants of series ALLR TO 3 that were issued in connection with the Company’s issue of units in June 2021 (Press release, Allarity Therapeutics, SEP 14, 2021, View Source [SID1234587747]). In total, 9,719,266 warrants of series TO 3 were exercised, corresponding to approximately 6.7 percent of the total number of outstanding warrants, for subscription of 9,719,266 shares at a subscription price of SEK 1.7 per share. Through the exercise of the warrants, Allarity will receive approximately SEK 16.5 million (U.S. $1.9 million) before issuing costs amounting to approximately SEK 1.8 million.

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Chairman of Allarity’s Board of Directors Duncan Moore (who exercised 283,407 warrants) and the Company’s largest shareholder, Sass & Larsen ApS, were among the subscribers.

The exercise period for the warrants of series TO 3 took place from August 30 up to and including September 13, 2021. The accelerated exercise period was established, as previously announced, due to the Board of Directors’ determination that it was in the best interest of all shareholders as part of the Company’s plan to move to the U.S. Nasdaq stock market and to meet the requirements of the previously announced U.S. $20 Million recapitalization investment with 3i LP (New York).

Exercised warrants will be replaced with interim shares, pending registration with the Danish Business Authority. The interim shares are expected to be converted to shares within approximately two (2) weeks. Through the exercise, the number of shares in the Company increase from 390.063.114 shares to 399.782.380 shares, and the share capital increase by DKK 485,963.3, from DKK 19.503.155,70 to DKK 19,989,119.00.

Steve Carchedi, CEO of Allarity, commented, "I am pleased that our Company has completed the exercise of series TO 3 warrants, as this step is to secure our foundational investment by 3i LP and will support our migration to the U.S. Nasdaq stock market, which I believe will enable us to unlock the true value of our Company."

On September 14, 2021 Checkmate Pharmaceuticals Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported that Barry Labinger, CEO, will present at the Cantor Virtual Global Healthcare Conference on Thursday, September 30 from 10:40-11:10am ET (Press release, Checkmate Pharmaceuticals, SEP 14, 2021, View Source [SID1234587746]). Checkmate will also host 1×1 investor meetings during the conference.

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The webcast can be accessed under "Events & Presentations" in the Investors section of the Checkmate website. An archived copy of the webcast will be available on the Checkmate website for approximately 90 days after the event.

On September 14, 2021 Avalo Therapeutics, Inc. ("Avalo" or the "Company") (Nasdaq: AVTX), a leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet clinical need in immunology, immuno-oncology, and rare genetic diseases, reported that it intends to offer for sale shares of its common stock in an underwritten public offering (Press release, Avalo Therapeutics, SEP 14, 2021, View Source [SID1234587735]). Avalo intends to grant the underwriters a 30-day option to purchase additional shares of its common stock sold in the proposed offering of up to 15% of the aggregate number of shares of common stock. All of the shares of common stock will be offered by Avalo. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies and RBC Capital Markets are acting as joint book-running managers for the offering.
Avalo intends to use the net proceeds of the offering for working capital and other general corporate purposes.

This offering by Avalo is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-254000), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on March 8, 2021 and declared effective by the SEC on March 19, 2021, and the accompanying prospectus contained therein. The offering of the shares of common stock will be made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC, and will be available on the SEC’s website at View Source or by contacting Jefferies LLC at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by e-mail at [email protected] or by calling (877) 547-6340; and RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281-8098 or by telephone at 877-822-4089 or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that Avalo has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about Avalo and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the shares of common stock described herein, nor shall there be any sale of these shares of common stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 14, 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 14, 2021, View Source [SID1234587719]).

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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.