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 [SID1234597226]).

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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 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on oncology, anti-infective products in adjunct cancer care, unique prescription products, and stem cell therapies, reported business and financial results for the fiscal full year ended September 30, 2021 (Press release, Citius Pharmaceuticals, DEC 15, 2021, View Source [SID1234597255]).

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Fiscal Full Year 2021 Business Highlights and Subsequent Developments

Completed subject treatment in December 2021 in Pivotal Phase 3 trial of I/ONTAK (E7777) with topline results anticipated in the first half of 2022 and a biologics license application (BLA) submission in the second half of 2022;
Acquired Dr. Reddy’s Laboratories’ license for late-Phase 3 oncology immunotherapy I/ONTAK for the treatment of cutaneous T-cell lymphoma (CTCL) and other cancer indications;
Received third positive recommendation from independent Data Monitoring Committee to continue the Mino-Lok Phase 3 clinical superiority trial as planned without modifications; no safety concerns identified;
Completed dose-ranging proof-of-concept sheep study of iPSC-derived novel induced-mesenchymal stem cells (i-MSCs) for the treatment of acute respiratory distress syndrome (ARDS); analysis and documentation underway for peer-reviewed publication submission;
Expanded clinical, manufacturing and commercial capabilities with the addition of seasoned pharmaceutical executives;
Citius added to the Russell 3000 and 2000 indexes; and,
Raised net proceeds of $120.6 million in financing activities during the year.
Financial Highlights

Cash and cash equivalents of $70.1 million as of September 30, 2021;
R&D expenses were $12.2 million for the full year ended September 30, 2021, compared to $8.8 million for the full year ended September 30, 2020;
G&A expenses were $9.8 million for the full year ended September 30, 2021, compared to $8.1 million for the full year ended September 30, 2020;
Stock-based compensation expense was $1.5 million for the full year ended September 30, 2021, compared to $0.8 million for the full year ended September 30, 2020; and,
Net loss was $23.1 million, or ($0.23) per share for the full year ended September 30, compared to a net loss of $17.5 million, or ($0.45) per share for the full year ended September 30, 2020.
"2021 was a transformative year for Citius as we positioned the company financially and strategically to drive growth. We raised more than $120 million in proceeds to support our activities, providing us with the flexibility to advance our clinical programs and invest in opportunities for additional growth. With the recent addition of cancer immunotherapy I/ONTAK to our portfolio, we now have a robust pipeline that includes two late Phase 3 programs and three potentially first-in-class products," stated Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals.

"As we move into 2022, we anticipate multiple positive milestones. These include: accelerated enrollment and completion of the Mino-Lok trial during the year, topline results in the first half of 2022 for the recently completed I/ONTAK Pivotal Phase 3 trial followed by a BLA submission in the second half of the year, initiation of the Halo-Lido study in early 2022 and completion of the study by the end of the year, and continued progress on Mino-Wrap and our iPSC-derived mesenchymal stem cells for the treatment of acute respiratory distress syndrome (ARDS). With the addition of key personnel to our clinical, manufacturing and commercial teams, we are aligning our resources to ensure continued progress across each of our development programs, and the successful launch of potentially two commercial products in 2023. We believe our strong balance sheet will allow us to execute our development programs as planned in 2022 and we do not anticipate a need to raise additional capital in the coming year," concluded Mr. Holubiak.

Full Year 2021 Financial Results:

Liquidity

As of September 30, 2021, the Company had $70.1 million in cash and cash equivalents. During the fiscal year ended September 30, 2021, the Company received net proceeds of $120.6 million from financing activities.

In January 2021, the Company closed a private placement for common stock and warrants totaling gross proceeds of approximately $20 million and net proceeds of $18.5 million. In February 2021, the Company closed a registered direct offering of its common stock and warrants for gross proceeds of $76.5 million and net proceeds of $71 million. During the year ended September 30, 2021, the Company received $31.2 million in proceeds from the exercise of common stock options and warrants.

On June 21, 2021, stockholders approved an amendment to the Company’s Articles of Incorporation to increase the authorized number of shares from 210,000,000 to 410,000,000 and the authorized number of common shares from 200,000,000 to 400,000,000. As of September 30, 2021, the Company had 145,979,429 common shares issued and outstanding.

In 2021, the Company raised a total of $127.6 million through financing activities. We estimate that we will have sufficient funds for our operations through March 2023.

Research and Development (R&D) Expenses

R&D expenses were $12.2 million for the full year ended September 30, 2021, compared to $8.8 million for the full year ended September 30, 2020. The increase of $3.4 million is primarily due to an increase in research and development expenses for our proposed novel cellular therapy for ARDS of $6.1 million, of which $5 million was a license fee paid to Novellus, and an increase in R&D expenses related to the I/ONTAK license and Mino-Wrap, offset by decreases in research and development expenses related to our Mino-Lok and Halo-Lido product candidates.

We expect that research and development expenses will increase in fiscal 2022 as we continue to focus on our Phase 3 trial for Mino-Lok, progress the Halo-Lido product candidate, and continue our research and development efforts related to ARDS, Mino-Wrap and I/ONTAK (E7777).

General and Administrative (G&A) Expenses

G&A expenses were $9.8 million for the full year ended September 30, 2021, compared to $8.1 million for the full year ended September 30, 2020. The primary reason for the increase is costs associated with additional compensation costs for new employees and performance bonuses. General and administrative expenses consist primarily of compensation costs, professional fees related to our capital raising activities, corporate development services, and investor relations.

Stock-based Compensation Expense

For the full year ended September 30, 2021, stock-based compensation expense was $1.5 million as compared to $0.8 million for the prior year. The increase reflects expenses related to new grants made by Citius and the NoveCite stock option plan.

Net loss

Net loss was $23.1 million, or ($0.23) per share for the year ended September 30, compared to a net loss of $17.5 million, or ($0.45) per share for the year ended September 30, 2020. The increase in net loss is primarily due to the $3.4 million increase in our research and development expenses and a $1.6 million increase in general and administrative expenses.

On December 15, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that CEO Snehal Patel participated in a TD Ameritrade interview to discuss the Phase IIb poster presented at the 2021 San Antonio Breast Cancer Symposium on December 9, 2021 (Press release, Greenwich LifeSciences, DEC 15, 2021, View Source [SID1234597195]).

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Mr. Patel appeared for a second time as a featured guest in a live interview on TD Ameritrade Network’s The Watch List with host Nicole Petallides. A webcast of the interview can be seen here.

In the interview, Mr. Patel discussed how the new Phase IIb clinical trial findings could lead to a new treatment that complements GP2 peptide therapy and allows doctors to detect metastatic breast cancer recurrences earlier. The newly published Phase IIb clinical trial data shows that 22.8% of 145 patients had an immune response to GP2 prior to any treatment with GP2. Typically, no response to GP2 would be expected until after treatment with GP2. However, an immune response was seen in these patients before any treatment with GP2, suggesting that their cancer was already recurring. The data suggests that patients with an immune response to GP2 prior to treatment recurred twice as fast and approximately 7 to 11 months sooner than those without an immune response prior to treatment did. The number of recurrences was low in the Phase IIb clinical trial, so these observations will be confirmed further in the larger Phase III trial, and the data will be available as early as 2022.

Mr. Patel continued to discuss how in the Phase III clinical trial, T cells will be fully characterized and identified at the DNA level to better understand the initial immune response to GP2. GP2 immunotherapy trains T cells to attack metastatic breast cancer. By identifying the GP2 specific T cells that are attacking the cancer, the most effective T cells could be developed as drug candidates and given directly to patients as a treatment using CAR-T cell technology. Thus the Company could use this new patentable T cell technology for both diagnosis and treatment, expanding the Company’s pipeline beyond just GP2 and further benefiting patients.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On December 15, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its lead program, investigating ST101 for the treatment of advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy (Press release, Sapience Therapeutics, DEC 15, 2021, View Source [SID1234597227]). This is the second FTD designation received for the ST101 program, following FTD for recurrent glioblastoma (GBM), announced in early December 2021. ST101 is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors, which includes expansion cohorts in patients with cutaneous melanoma and refractory GBM.

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Dr. Barry Kappel, Sapience’s CEO and President, commented, "Melanoma is the fifth most diagnosed cancer in the U.S., with more than 100,000 new cases per year, and no well-established standard of care treatment regimen. We believe we have a significant opportunity to deliver a novel therapeutic option with ST101, which has a durable clinical efficacy and an excellent safety profile, for melanoma patients whose disease has progressed following treatment with anti-PD-1 therapy."

Dr. Gina Capiaux, PhD, Sapience’s Head of Regulatory Affairs added, "This is the second Fast Track designation received for ST101, underscoring the advancement of our ST101 program and its potential therapeutic benefit for both melanoma and GBM patients. We are grateful for the opportunity to quickly advance the development of ST101 for patients in need."

Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Sapience also previously received Orphan Drug Designation from the U.S. FDA and European Commission for ST101 for the treatment of glioma.

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted Fast Track Designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation by the European Commission for the treatment of glioma.

On December 15, 2021 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with high-grade gliomas, including glioblastoma multiforme (Press release, Nuvation Bio, DEC 15, 2021, View Source [SID1234597256]). NUV-422 received Orphan Drug Designation for the treatment of patients with malignant gliomas from the FDA in the first quarter of 2021.

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"We are pleased that NUV-422 received FDA Fast Track designation because it highlights the serious unmet need of patients with brain cancer and the potential of our lead drug candidate NUV-422 to serve as an innovative new treatment option for high-grade gliomas, including glioblastoma multiforme," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "Enrollment is ongoing in our expanded Phase 1/2 monotherapy study of NUV-422 for the treatment of adults with recurrent or refractory high-grade gliomas and solid tumors. We look forward to continuing to work closely with the FDA to expedite the development of NUV-422 with data from the Phase 1 portion of the study, which is on track for 2022."

NUV-422 is the Company’s lead investigational CDK2/4/6 inhibitor program that works to overcome the limitations of CDK4/6 inhibitors. CDK4/6 inhibitors are known clinical entities with proven efficacy, but some cancer cells can evade these treatments by increasing signaling through CDK2. Inhibition of CDK2 in addition to CDK4/6 cuts off the tumor’s natural escape route. NUV-422 is a potent inhibitor of CDK 2, 4, and 6. Preclinical studies have shown that NUV-422 has favorable blood-brain barrier penetration. NUV-422 is also designed to limit CDK1 inhibition, a potential cause of toxicity in other second-generation inhibitors. In addition to high grade gliomas, NUV-422 is currently being studied in HR+ HER2- advanced breast cancer (with and without brain metastases) and metastatic castration resistant prostate cancer (mCRPC). Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need with the goal of getting important new drugs to patients earlier. A drug that receives Fast Track designation is eligible for more frequent meetings and communications with the FDA, accelerated approval and priority review if certain criteria are met, and more.