On October 10, 2021 BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that BRUKINSA (zanubrutinib) has been approved in Australia for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (Press release, BeiGene, OCT 10, 2021, View Source [SID1234591037]). On October 7, 2021, BRUKINSA received its initial approval in Australia for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy.1

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"Our early BRUKINSA clinical trials started in Australia and coming off the heels of BRUKINSA’s TGA registration for the treatment of WM, we are delighted to be able to provide BRUKINSA to more Australians in need of new treatment options."

Following registration of BRUKINSA with the Australian Therapeutic Goods Administration (TGA) in both approved indications, these patients will have immediate access to BRUKINSA through the BeiGene sponsored post-approval, pre-reimbursement access program.

"Mantle cell lymphoma is an uncommon form of non-Hodgkin lymphoma that is generally considered incurable. While the majority of patients respond well to their initial treatment, virtually all will develop progressive lymphoma over time. Existing therapies for patients with recurrent or refractory MCL are often ineffective or have side effects that can lead to treatment discontinuation," said Professor Stephen Opat, Director of Clinical Haematology at Monash Health and a principal investigator in the zanubrutinib clinical program. "I’m encouraged that zanubrutinib – a highly selective BTK inhibitor with promising clinical results from two trials in relapsed or refractory MCL – will provide a new treatment option for these patients living in Australia."

"Australia has some of the highest rates of non-Hodgkin’s lymphoma in the world, and these patients need options for treatment beyond those that exist today," said Sharon Winton, CEO, Lymphoma Australia. "MCL patients will certainly welcome the news that BeiGene is providing access to BRUKINSA by sponsoring a pre-reimbursement program, as new therapies are critical, especially to those diagnosed later in life when it may be challenging to tolerate more aggressive types of treatment."

BeiGene submitted for reimbursement of BRUKINSA to the Australian Pharmaceutical Benefits Advisory Committee (PBAC), with MCL recommended for listing in July 2021.

"BRUKINSA was designed to provide deep and durable responses while reducing off-target side effects compared to first-generation BTK inhibitors," said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. "Our early BRUKINSA clinical trials started in Australia and coming off the heels of BRUKINSA’s TGA registration for the treatment of WM, we are delighted to be able to provide BRUKINSA to more Australians in need of new treatment options."

More than 6,000 people are diagnosed with non-Hodgkin’s lymphoma (NHL) in Australia each year, making it the sixth most common cancer in adults.2 MCL is a B-cell NHL that develops in the outer edge of a lymph node called the mantle zone.3 MCL usually has a poor prognosis, with a median survival of three to six years, and is often diagnosed at a later stage of disease.3

The Australian registration for BRUKINSA in MCL is based on efficacy results from two single-arm clinical trials. Across both trials, as assessed by independent review committee (IRC) per 2014 Lugano Classification, BRUKINSA achieved an overall response rate (ORR) of 83.7%, defined as the combined rate of complete responses (CRs) and partial responses (PRs).

In the multicenter Phase 2 trial of zanubrutinib in patients with relapsed or refractory (R/R) MCL BGB-3111-206 (NCT03206970), with a median follow-up time of 18.4 months, the ORR was 83.7% (95% CI: 74.2, 90.8), including 68.6% CRs (FDG-PET scan required) and 15.1% PRs; the median duration of response (DoR) was 19.5 months (95% CI: 16.6, NE). In the global Phase 1/2 trial BGB-3111-AU-003 (NCT02343120), with a media follow-up time of 14.75 months, the ORR was 84.4% (95% CI: 67.2, 94.7), including 25.0% CRs (FDG-PET scan not required) and 59.4% PRs; the median DoR was 18.5 months (95% CI: 12.6, NE).

Of the 118 patients with MCL who received at least one prior therapy and received BRUKINSA treatment, 13.6% of patients discontinued treatment due to adverse events in the trials, with the most frequent being pneumonia (3.4%). Adverse events leading to dose reduction occurred in 3.4% of patients, including hepatitis B, neutropenia, allergic dermatitis, and peripheral sensory neuropathy (in one patient each).

The overall safety profile of BRUKINSA is based on pooled data from 779 patients with B-cell malignancies treated with BRUKINSA in clinical trials. The most common adverse reactions (≥20%) with BRUKINSA were neutropenia, thrombocytopenia, upper respiratory tract infection, hemorrhage/hematoma, rash, bruising, anemia, musculoskeletal pain, diarrhea, pneumonia, and cough. The most common Grade 3 or higher adverse reactions (≥5%) were neutropenia, thrombocytopenia, pneumonia, and anemia.

The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.

About BRUKINSA (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesised, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimising bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA is approved in the following indications and regions:

For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021);
For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021);
Registered and reimbursed for the treatment of MCL in patients who have received at least one prior therapy (Israel, April 2021);
For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**;
For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021);
For the treatment of MCL in adult patients who have received at least one prior therapy (Chile, July 2021);
For the treatment of adult patients with MCL who have received at least one previous therapy (Brazil, August 2021);
For the treatment of adult patients with WM (United States, August 2021);
For the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (United States, September 2021)*;
For the treatment of adult patients with MCL who have received at least one previous therapy (Singapore, October 2021);
For the treatment of adult patients with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy (Australia, October 2021); and
For the treatment of adult patients with MCL who have received at least one prior therapy (Australia, October 2021).
To date, more than 30 marketing authorization applications in multiple indications have been submitted in the United States, China, the European Union, and more than 20 other countries or regions.

* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB)

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.4% of patients treated with BRUKINSA monotherapy. Hemorrhage events of any grade occurred in 35% of patients treated with BRUKINSA monotherapy.

Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 27% of patients, most commonly pneumonia. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (26%), thrombocytopenia (11%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 13% of patients, and Grade 4 thrombocytopenia occurred in 3.6% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer, reported in 8% of patients. Other second primary malignancies included malignant solid tumors (4.0%), melanoma (1.7%) and hematologic malignancies (1.2%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Atrial fibrillation and atrial flutter were reported in 3.2% of patients treated with BRUKINSA monotherapy. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher events were reported in 1.1% of patients treated with BRUKINSA monotherapy. Monitor signs and symptoms for atrial fibrillation and atrial flutter and manage as appropriate.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse reactions

The most common adverse reactions, including laboratory abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847) included decreased neutrophil count (54%), upper respiratory tract infection (47%), decreased platelet count (41%), hemorrhage (35%), decreased lymphocyte count (31%), rash (31%) and musculoskeletal pain (30%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with moderate or strong CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

Please see full U.S. Prescribing Information at www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf.

BeiGene Oncology

BeiGene is committed to advancing hematology, immuno-oncology and targeted therapies in order to bring impactful and affordable medicines to patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy subjects. Our expansive portfolio is directed by a predominantly internalised clinical development team supporting trials in more than 40 countries or regions. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China. BeiGene has a high quality, innovative science and medicine organisation and is a leader in China with a large oncology focused commercial team.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialise a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialise tislelizumab in North America, Europe, and Japan.

On October 8, 2021 Blue Water Vaccines, Inc. ("BWV" or "Blue Water Vaccines" or "the Company") a biopharmaceutical company developing vaccines, reported that it has filed a registration statement (Registration No.: 333-260137) on Form S-1 with the U.S. Securities and Exchange Commission relating to the proposed initial public offering of its common stock (Press release, Onconetix, OCT 8, 2021, View Source [SID1234641101]). The shares of common stock to be sold in the offering are expected to be offered by the Company. The number of shares to be offered and the price range for the proposed offering have not yet been determined.

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Maxim Group LLC will serve as sole book-running manager for the proposed offering. The Company plans to use the proceeds from this offering to fund its research and development activities, for working capital and other general corporate purposes. The proposed offering will be made only by means of a prospectus, which forms a part of the registration statement. Copies of the registration statement and the preliminary prospectus included therein relating to the proposed offering, when available, may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov.

A registration statement on Form S-1 (Registration No.: 333-260137)relating to the proposed sale of these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective.

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

On October 8, 2021 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, reported the pricing of concurrent but separate underwritten public offerings of 14,838,706 shares of its common stock at a price to the public of $1.55 per share and 774,194 shares of its Series X Convertible Preferred Stock at a price to the public of $15.50 per share (Press release, Cidara Therapeutics, OCT 8, 2021, View Source [SID1234636983]). The gross proceeds to Cidara from these offerings, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $35.0 million.

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In addition, with respect to the common stock offering, Cidara has granted the underwriters a 30-day option to purchase up to an additional 2,225,805 shares of its common stock at the public offering price of $1.55 per share less underwriting discounts and commissions. The offerings are expected to close on or about October 13, 2021, subject to satisfaction of customary closing conditions. The closing of each offering is not contingent upon the closing of the other.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for each offering. Wedbush Securities is acting as the lead manager. Needham & Company, LLC, Maxim Group LLC and Aegis Capital Corp. are acting as co-managers.

The securities described above are being offered by Cidara pursuant to a shelf registration statement, which has been declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus and prospectus supplements. Preliminary prospectus supplements and the accompanying prospectus relating to the offerings have been filed with the SEC and are available for free on the SEC’s website at View Source Final prospectus supplements and the accompanying prospectus relating to the offerings will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplements and the accompanying prospectus relating to these offerings, when available, may be obtained from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

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

On October 8, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported the filing by 2seventy bio of an updated Form 10 Registration Statement with the U.S. Securities and Exchange Commission (SEC) (Press release, 2seventy bio, OCT 8, 2021, View Source [SID1234594668]). This Form 10 reflects bluebird bio’s plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company. The spin-off is on track to be completed by early November 2021. bluebird bio also announced the appointment of Najoh Tita-Reid and Sarah Glickman to the bluebird bio board of directors. Upon effectiveness of the Form 10, Ms. Glickman will also be a member of the board of directors of 2seventy bio and will step down from the bluebird bio board of directors upon completion of the spin-off.

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"As we approach separation, we have been strategic and diligent in setting up each business for success," said Nick Leschly, chief bluebird and expected chief kairos officer, 2seventy bio. "The first part of this year was largely directed toward focusing and shaping our internal operations and continuing to advance the transformative gene and cell therapy products that sit on both sides of the current business. Rounding out those necessary pillars for success is financial strength and leadership, and we’re extremely pleased to share today further detail on the balance sheet that each company is expected to launch with, as well as key members of each board of directors. This is another step forward and we remain on track to launch bluebird bio and 2seventy bio by early November with the right pieces in place to drive both entities toward delivering for patients with meaningful, value-creating milestones."

Upon separation, bluebird bio plans to distribute 100% of the outstanding shares of 2seventy bio common stock to bluebird’s shareholders in a 3:1 ratio. For every three shares of bluebird bio stock, current shareholders will receive one share of 2seventy bio stock.

The company anticipates that its cash, cash equivalents and marketable securities balance at separation will be approximately $1.0B, inclusive of proceeds from the recent sale of the company’s manufacturing facility in North Carolina and its private placement equity financing. bluebird bio expects to fund 2seventy bio with approximately $480M in cash upon separation, with the balance to be retained by bluebird bio. Together with existing and emerging sources of revenue and other anticipated cash inflows, which includes the potential sale of priority review vouchers that would be issued with anticipated U.S. regulatory approvals of BLAs for bluebird’s therapies in beta-thalassemia and cerebral adrenoleukodystrophy, the Company expects its cash, cash equivalents and marketable securities balance will be sufficient to fund operations for bluebird bio and 2seventy bio into 2023 under current business plans.

The company also announced the appointment of two new board members.

Najoh Tita-Reid was appointed to the bluebird bio board of directors. Najoh Tita-Reid is Chief Marketing Officer for Logitech, a global manufacturer of computer peripherals, software and services with headquarters in Switzerland and California. In her role, Ms. Tita-Reid is leading the transformation of the global marketing function and spearheading a strategic, digital-first and data-driven consumer and customer omnichannel experience. A multi-faceted executive with global marketing expertise, she has a record of strategic and operational ingenuity and transformation across complex organizations. Prior to her role at Logitech, Ms. Tita-Reid was Global Chief Marketing Officer and Executive Board Member for Hero-AG, a family-run healthy food company, and held leadership positions at Bayer PLC and Merck & Co, Inc. Ms. Tita-Reid spent 19 years at Procter & Gamble where she managed several multi-billion-dollar brands. She also led African American Marketing for P&G, the world’s largest advertiser, and created breakthrough marketing strategies, including "My Black is Beautiful," which stands as a template for multi-cultural campaigns across industry today. Ms. Tita-Reid graduated with a Bachelor of Arts from Spelman College and holds an MBA from Fuqua School of Business at Duke University.

"As we approach separation, we are in a strong financial and operational position and poised to unlock value both for our patients and our shareholders," said Andrew Obenshain, president, severe genetic diseases and expected chief executive officer, bluebird bio, post separation. "We are pleased to welcome Najoh to bluebird bio’s board of directors and look forward to benefiting from her expertise in multi-brand strategy and execution as we enter the next chapter for bluebird bio, focused on the commercialization of three transformational gene therapies for severe genetic diseases."

Sarah Glickman was also appointed to the bluebird bio board of directors and is expected to join the 2seventy bio board of directors as Audit Committee Chair upon separation. Ms. Glickman is the Chief Financial Officer for Criteo, a global technology company headquartered in Paris, France and listed on Nasdaq. She jointly leads Criteo’s strategy to drive profitable long-term growth and shareholder value through transformational change, including M&A. Key responsibilities include leading all aspects of financial planning and reporting, investor relations, treasury, tax, controllership and internal controls. She is also responsible for global IT, procurement and real estate. Prior to Criteo, she was the acting Chief Financial Officer and Chief Transformation Officer of XPO Logistics in Greenwich, CT. Prior to XPO, she was the Chief Financial Officer for the Novartis Business Services division of Novartis AG, a global pharmaceutical company. Ms. Glickman spent ten years at Honeywell, Inc. and before held finance roles at Bristol-Myers Squibb and PricewaterhouseCoopers. She is a Certified Public Accountant (US) and Fellow Chartered Accountant (UK) and graduated with a Bachelor of Arts in Economics and History, with honors, from the University of York in England.

"We’re excited that Sarah will join the board of 2seventy bio in this crucial launch phase," said Nick Leschly. "Her financial leadership experience at several successful companies will be a tremendous asset as we focus on shoring up our balance sheet and setting up 2seventy bio with a healthy foundation to enable the continued advancement of our cell therapy platform."

On October 8, 2021, Adhera Therapeutics, Inc. (the "Company") reported that entered into a Securities Purchase Agreement ("SPA") with an institutional investor (the "Buyer"), pursuant to which the Company issued the Buyer a 10% Convertible Redeemable Note in the principal amount of $131,250 (the "Note") and a three-year warrant to purchase 476,190 shares of common stock of the Company (the "Warrant") for which the Company received consideration of $110,000 (Filing, 8-K, Adhera Therapeutics, OCT 8, 2021, View Source [SID1234591173]).

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The Note is due October 5, 2022. The Note provides for guaranteed interest at the rate of 10% per annum, payable at maturity. The Note is convertible into shares of common stock at any time following the date of cash payment at the Buyer’s option at a conversion price of $0.075 per share, subject to certain adjustments. Furthermore, the Buyer will not be allowed to effect a conversion if such conversion, along with all other shares of the Company’s common stock beneficially owned by the Buyer and its affiliates would exceed 4.99% of the outstanding shares of common stock of the Company, which may be increased up to 9.9% upon 60 days’ prior written notice by the Buyer.

The Warrants are exercisable for three-years from October 5, 2021 at an exercise price of $0.095 per share, subject to certain adjustments, which exercise price may be paid on a cashless basis. The aggregate exercise price is $45,238.05.

Pursuant to the SPA, the Company shall have filed a registration statement within 90 days providing for the registration of all shares issuable upon conversion of the Note and exercise of the Warrant.

For services rendered in connection with the SPA, the Company paid Carter, Terry & Company a fee of $10,000. In addition, the Company reimbursed the Buyer $5,000 for legal expenses incurred in connection with the transaction.

The foregoing description of the terms of the SPA, the Note, the Warrant and the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to the form of SPA, the form of Note, and the form of Warrant, a copy which is filed as Exhibits 10.1, 10.2, and 10.3, respectively, to this Current Report on Form 8-K and is incorporated herein by reference.