On December 15, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT) ("Corcept"), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported an update to its offer to purchase up to 10,000,000 shares of its common stock at a price not greater than $23.75 nor less than $20.75 per share closing at one minute after 11:59 P.M., New York City time, on December 15, 2021 (the "Tender Offer") (Press release, Corcept Therapeutics, DEC 15, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-waiver-condition-its-tender-offer [SID1234597190]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Corcept’s Board of Directors has determined that it is advisable to proceed with the Tender Offer despite the recent fluctuations in the price of Corcept’s stock and has therefore declined to exercise Corcept’s option, as set forth in the offer to purchase, to terminate the Tender Offer due to changes in the company’s stock price.
The Tender Offer is subject to other terms and conditions, which are described in detail in the offer to purchase. Except for the waiver of the share price condition set forth above, the terms and conditions of the Tender Offer remain the same.

None of Corcept, the members of its Board of Directors, the dealer manager, the financial advisor, the information agent or the depositary for the Tender Offer makes any recommendation as to whether or not any stockholder should participate in the Tender Offer or as to the purchase price or purchase prices at which stockholders may choose to tender their shares.

The sole dealer manager for the Tender Offer is Truist Securities, Inc. D.F. King is serving as the information agent for the Tender Offer and Continental Stock Transfer & Trust Company is serving as the depositary. Canaccord Genuity LLC is serving as a financial advisor. For all questions relating to the Tender Offer, please contact the information agent, D.F. King & Co., Inc. at [email protected] or call toll-free at 1 (800) 431-9646, or call the dealer manager, Truist Securities, Inc. at 1 (404) 926-5832.

On December 15, 2021 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative pharmacology, biomarker, and data platforms, reported its financial results for its second quarter of fiscal 2022, ended October 31, 2021 (Press release, Champions Oncology, DEC 15, 2021, View Source [SID1234597189]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter and Recent Highlights:

Record quarterly revenue of $11.8 million, an increase of 17% year over year
Reported non-GAAP income from operations, excluding stock-based compensation, depreciation and amortization, of $743,000
Gross margin improved to 52%
Ronnie Morris, CEO of Champions, commented, "We had another quarter of milestone achievements for the Company as we saw strong operating results in our research service business and continued to expand the customer base of our SaaS Lumin platform." Morris added, "We’re advancing our therapeutic targets along the drug discovery pipeline and we’re excited about their progress and transformative potential for Champions."

David Miller, CFO of Champions, said, "We achieved another quarterly revenue record reaching $11.8 million. Additionally, by improving efficiencies and reducing certain costs, we improved our gross and operating margins all while continuing to increase R&D investment to support longer term strategic initiatives."

Second Fiscal Quarter Financial Results

For the second quarter of fiscal 2022, revenue increased 17% to $11.8 million compared to $10.1 million for the second quarter of fiscal 2021. The increase in revenue was due to continued demand for our pharmacology studies and the expansion of both our platform and product lines, driving an increase in sales, both in number and size of studies. Total costs and operating expenses for the second quarter of fiscal 2022 were $11.5 million compared to $10.1 million for the second quarter of fiscal 2021, an increase of $1.4 million or 14.0%.

For the second quarter of fiscal 2022, Champions reported net income from operations of $263,000, including $134,000 in stock-based compensation and $346,000 in depreciation and amortization expenses, compared to income from operations of $7,000, inclusive of $85,000 in stock-based compensation and $307,000 in depreciation and amortization expenses, in the second quarter of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $743,000 for the second quarter of fiscal 2022 compared to non-GAAP income from operations of $399,000 in the second quarter of fiscal 2021.

Cost of oncology solutions was $5.6 million for the three-months ended October 31, 2021, a decrease of $35,000, or (0.6)% compared to $5.6 million for the three-months ended October 31, 2020. For the three-months ended October 31, 2021, gross margin was 52.4% compared to 44.2% for the three-months ended October 31, 2020. Total cost of sales remained flat as we reduced the level of outsourcing required. The cost reduction more than offset the increase in compensation and lab supply expenses resulting from the increase in study volume.

Research and development expense for the three-months ended October 31, 2021 was $2.3 million, an increase of $649,000 or 39.3%, compared to $1.7 million for the three-months ended October 31, 2020. The increase was primarily from compensation and sequencing costs as we increased investment in our therapeutic target discovery platform. Sales and marketing expense for the three-months ended October 31, 2021 was $1.6 million, an increase of $292,000, or 21.7%, compared to $1.3 million for the three-months ended October 31, 2020. The increase was primarily due to compensation expense driven by the continued investment to expand our salesforce, including the addition of a dedicated SaaS business development team for our Lumin Bioinformatics platform. General and administrative expense for the three-months ended October 31, 2021 was $2.0 million, an increase of $507,000, or 34.5%, compared to $1.5 million for the three-months ended October 31, 2020. The increase was primarily due to an increase in compensation and IT related expenses.

Net cash generated from operating activities for the quarter was $1.2 million resulting from increased operating income excluding stock compensation and other non-cash related expenses. Net cash used in investing activities was $495,000 primarily from investment in additional lab equipment and software development. The Company ended the quarter with a strong cash position of $4.8 million. The Company has no debt.

Year-to-Date Financial Results

For the first six months of fiscal 2022, revenue increased 17% to $23.0 million compared to $19.7 million for the first six months of fiscal 2021. The increase in revenue was due to the expansion of our platforms and business lines. Total costs and operating expenses for the first six months of fiscal 2022 were $23.0 million compared to $19.6 million for the first six months of fiscal 2021, an increase of $3.3 million or 17%.

For the first six months of fiscal 2022, Champions reported net income from operations of $88,000, including $414,000 in stock-based compensation and 663,000 in depreciation and amortization expenses, compared to income from operations of $31,000, inclusive of $205,000 in stock-based compensation and $584,000 in depreciation and amortization expenses, in the first six months of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $1.2 million for the first six months of fiscal 2022 compared to non-GAAP income from operations of $822,000 in the first six months of fiscal 2021.

Cost of oncology solutions was $11.0 million for the six-months ended October 31, 2021, a slight increase of $25,000, or 0.2% compared to $11.0 million for the six-months ended October 31, 2020. For the six-months ended October 31, 2021, gross margin was 52.2% compared to 44.2% for the six-months ended October 31, 2020. The improvement in gross margin was primarily attributable to decreasing the Company’s reliance on outsourcing while continuing to grow revenue.

Research and development expense for the six-months ended October 31, 2021 was $4.6 million, an increase of $1.4 million or 41.8%, compared to $3.2 million for the six-months ended October 31, 2020. The increase was primarily from compensation, sequencing costs, and lab supplies as we increased investment in our therapeutic target discovery platforms. Sales and marketing expense for the six-months ended October 31, 2021 was $3.2 million, an increase of $658,000, or 25.7%, compared to $2.6 million for the six-months ended October 31, 2020. The increase was primarily due to compensation expense driven by the continued investment in expanding our business development teams. General and administrative expense for the six-months ended October 31, 2021 was $4.1 million, an increase of $1.3 million, or 44.9%, compared to $2.9 million for the six-months ended October 31, 2020. The increase was primarily due to an increase in compensation as well as an increase in IT related expenses to support the overall infrastructure growth of the organization.

Net cash provided by operating activities was $1.4 million for the six-months ended October 31, 2021.The cash generated from operating activities was primarily due to operating income excluding stock compensation, depreciation and amortization expenses. Net cash used in investing activities was $1.5 million and was primarily from investment in additional lab equipment and software development.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 877-545-0320 (Domestic) or 973-528-0002 (International) and enter the access code 694190 ten minutes ahead of the call.

Full details of the Company’s financial results will be available by Tuesday, December 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 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 and six months ended October 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 December 15, 2021 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported new data highlighting the mechanism of action of plinabulin in the prevention of chemotherapy-induced neutropenia (CIN) at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, held virtually and in person in Atlanta, Georgia from December 11-14, 2021 (Press release, BeyondSpring Pharmaceuticals, DEC 15, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-announces-new-clinical-data-confirming-plinabulins-fast-onset-mechanism-of-action-in-the-prevention-of-chemotherapy-induced-neutropenia-at-the-63rd-ash-annual-mee [SID1234597188]). The data demonstrate that adding plinabulin to a myelosuppressive regimen rapidly reversed (within 24 hours) neutropenia and leukopenia in the PROTECTIVE-1 and -2 clinical studies by protecting progenitor stem cells in the bone marrow.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This clinical data provides evidence confirming the hypothesized progenitor stem cell protective mechanism of action for plinabulin, which further validates the positive Phase 3 data from the PROTECTIVE-2 clinical program. These data also build upon the rapid effect seen in clinical trials to date and support the opportunity for enhanced CIN prevention care with plinabulin," said Dr. Douglas Blayney, professor of medicine at Stanford University Medical School and global principal investigator for the CIN studies. "These data provide a strong rationale for combining plinabulin with pegfilgrastim, since the latter has a mechanism of action exerting CIN prevention in week 2 of the chemotherapy cycle while plinabulin shows a week 1 benefit. This early CIN benefit is critically important because these white blood cells are the body’s main source of defense against infection. If a cancer patient gets an infection due to CIN, it may affect their ability to finish chemotherapy for cancer treatment."

Dr. Ramon Mohanlal, executive vice president of research and development and chief medical officer at BeyondSpring Pharmaceuticals, added, "This presentation at ASH (Free ASH Whitepaper) provides mechanistic support for the observed benefit of plinabulin in the prevention of CIN, a condition that still has unmet medical need, despite the availability of the standard of care CIN prevention drug, G-CSF. In addition, the rapid onset of action is critical since week 1 of each chemotherapy cycle is when more than 75% of CIN cases occur, even with G-CSF. Investigating the nuances of how and when plinabulin works is a continuous part of our work in understanding this multifaceted therapy. We look forward to sharing more of these insights with the oncology community in future studies."

This poster was presented on Sunday, December 12, 2021 and is available on the ASH (Free ASH Whitepaper) website.

Poster Title: Plinabulin Rapidly (within 24 Hours) Reverses Myelosuppression Induced by Chemotherapy
Abstract Number: 2056
Key Findings:

This new data analysis from the PROTECTIVE-1 and 2 studies aimed to further evaluate plinabulin’s fast onset mechanism of action (MoA) and potential progenitor stem cell involvement in plinabulin’s fast onset MoA.
The comparison was made between cancer patients receiving plinabulin 40 mg (n=228) or not receiving plinabulin (n=172), and with all patients receiving myelosuppressive chemotherapy (docetaxel with or without doxorubicin and cyclophosphamide). Plinabulin 40 mg was given 30 minutes after chemotherapy.
Plinabulin rapidly (within 24 hours) reversed chemo-induced myelosuppression in both the PROTECTIVE-1 and 2 human studies. Plinabulin-mediated increases in cell numbers are dose-dependent and correlated among cells of the myeloid, lymphoid and erythroid lineages.
Neutrophils (p<0.0001; increase by >3x10E9/L with plinabulin and decrease by >0.5x10E9/L without plinabulin)
Monocytes (p=0.0023)
Eosinophils (p=0.0775)
Basophils (p<0.0001)
The data suggest that plinabulin targets granulocyte-monocyte-progenitor (GMP) stem cells (N, M, B and E progenitor) as well as progenitor cells further upstream in the hematopoietic lineage.
About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC) with recently released positive topline data. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation from both U.S. and China FDA for the CIN prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.

On December 15, 2021 Alligator Bioscience AB ("Alligator") and Aptevo Therapeutics ("Aptevo") (NASDAQ: APVO) reported publication of an article in the December 15, 2021, issue of the peer-reviewed journal, Nature Communications on the mechanism of action of CD137 (4-1BB) targeting bispecific antibodies (Press release, Alligator Bioscience, DEC 15, 2021, View Source [SID1234597187]). Nature Communications is an open access, multidisciplinary journal dedicated to publishing high-quality research in all areas of the biological, health, physical, chemical and Earth sciences.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The article titled, CD137 (4-1BB) co-stimulation of CD8 T cells is more potent when provided in cis than in trans with respect to CD3-TCR stimulation, details the mechanism of action of 4-1BB targeting bispecific antibodies. This work was published in collaboration by internationally renowned 4-1BB expert, Professor Ignacio Melero, and his team at the University of Navarra, Pamplona, Spain. Professor Melero’s data supports the bispecific antibodies, such as ALG.APV-527, targeting 4-1BB, and link 4-1BB signaling in cis (directly to tumor targets, such as 5T4), are more efficient at stimulating the anti-tumor response than bispecific agents that link 4-1BB signaling in trans to adjacent non-tumor cell targets such as the stroma.

"This study unveils an important mechanism for tumor-cell targeting therapies for cancer. Bispecific antibodies targeting 4-1BB offer a synthetic biology that can be very useful in cancer immunotherapy. In this study, we found a spatial requirement in regard to antigen recognition and 4-1BB co-stimulation. This means that the T cells can detect the antigen on the same cell that is providing natural or artificial 4-1BB co-stimulation. This type of co-stimulation, and the ensuing immune system activation and survival, is far more potent. The bispecific antibody from Alligator Bioscience and Aptevo Therapeutics, ALG.APV-527, is a tool that shows this potent 4-1BB co-stimulation in the tumor microenvironment and has the potential to provide a superior therapy to treat cancers," stated Ignacio Melero, MD, PhD, Cima and Clínica Universidad de Navarra, Spain.

"We are very pleased to have been selected for publication in a high-ranking peer-reviewed journal such as Nature Communications. This is very encouraging and validates the superior mechanism and design of ALG.APV-527. The data further highlights the strong positioning of ALG.APV-527 in the bispecific 4-1BB antibody field," said Søren Bregenholt, CEO at Alligator.

"The publication of Professor Melero’s findings further support the potential of ALG.APV-527 overall, to evoke an effective tumor-targeting immune response with fewer adverse events. This work highlights the potential differentiating benefit of ALG.APV-527 to induce stronger and more tumor-directed T cell responses with the potential for improved safety and efficacy in patients and represents a significant contribution from the scientific teams at Aptevo and Alligator. We are proud of their achievements and know their work will continue producing invaluable data going forward," commented Marvin White, CEO of Aptevo.

The complete article is available in print and in digital format which can be viewed via the following link: (link to article).

About ALG.APV-527

ALG.APV-527 is a 4-1BB and tumor-binding immunomodulatory antibody. 4- 1BB has the ability to stimulate the immune cells (anti-tumor specific T cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. The tumor-binding part of ALG.APV-527 targets the 5T4 tumor-associated antigen. 5T4 is a protein expressed in multiple tumor types, as well as certain types of aggressive tumor cells (tumor-initiating cells), but at low levels or not at all in normal tissue, making 5T4 a compelling target molecule for cancer therapy.

Alligator and Aptevo are advancing ALG.APV-527 into Phase I clinical development. The companies will continue to explore licensing opportunities as ALG.APV-527 moves into clinical development.

On December 15, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the appointment of Sara Kenkare-Mitra, Ph.D., as President and Head of Research and Development (Press release, Alector, DEC 15, 2021, View Source [SID1234597186]). In this newly created role, Dr. Kenkare-Mitra will lead all aspects of the company’s immuno-neurology and oncology R&D efforts, including oversight of the research, development, clinical, manufacturing, regulatory, and related functions. Dr. Kenkare-Mitra will report to Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Kenkare-Mitra joins Alector from Genentech where, as Senior Vice President, Development Sciences, she served as a member of the research and development leadership team, overseeing the transition of molecules from discovery to the clinic and their continued translation into medicines through clinical development. During her 23-year tenure, she led a large, integrated global organization of approximately 650 employees, and played a key role in the filing of more than 100 Investigational New Drug/clinical trial applications around the world, and the approval of 15 medicines for diverse diseases, including cancers and neurological diseases.

"Sara has an impressive background as a scientist, drug developer and leader, with a successful track record of building high-performing teams and fostering innovation in the development of new medicines," said Dr. Rosenthal. "As we continue to advance and grow our immuno-neurology and oncology programs, her expertise across all aspects of drug development and her passion for translational medicine will be invaluable to our team. I’m pleased to welcome Sara, and I look forward to partnering with her."

"Alector’s approach to harnessing the body’s innate immune system has the potential to transform the treatment of neurological diseases and certain cancers. With a combination of pioneering science and an exceptional team, we have a significant opportunity to play an important role in developing innovative treatments for patients in need," said Dr. Kenkare-Mitra. "I’m excited to join Alector and work closely with the team to fully realize the potential of the company’s deep portfolio."

Prior to joining Alector, Dr. Kenkare-Mitra held roles of increasing responsibility at Genentech over the course of 23 years. She most recently served as Senior Vice President, Development Sciences in Genentech’s research and early development unit. During her tenure, she served as a member of Genentech’s research review committee, development review committee and early-stage portfolio committee, as well as an ad-hoc member of the late-stage review committee. Dr. Kenkare-Mitra received her Ph.D. in Pharmaceutical Chemistry from the University of California, San Francisco, where she also stayed on as a Post-Doctoral Fellow in Clinical Pharmacology before joining Genentech. Dr. Kenkare-Mitra also holds adjunct faculty positions in the Department of Bioengineering and Therapeutic Sciences at the University of California, San Francisco and at the University of the Pacific in Stockton. Dr. Kenkare-Mitra is an elected member of the National Academy of Medicine (NAM) and the American Association for the Advancement of Science (AAAS). She has been widely recognized for her work in the industry with awards such as the American Association of Pharmaceutical Scientists’ Alice E. Till Advancement of Women in Pharmaceutical Sciences Recognition, Endpoints’ 20 Most Extraordinary Women in Biopharma, Fierce Pharma’s Fiercest Women in the Life Sciences, and the University of California, San Francisco’s Distinguished Alumnus of the Year.