On December 29, 2022 Rain Therapeutics Inc. ("Rain") (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, reported that it will change its name to Rain Oncology Inc. effective tomorrow, December 30, 2022, to better reflect the company’s focus on addressing unmet needs for cancer patients through precision oncology (Press release, Rain Therapeutics, DEC 29, 2022, View Source [SID1234625665]).

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"Our Company has always kept a steadfast focus on patients with cancer in an enduring passion to develop new precision oncology strategies. We felt it appropriate for our name to reflect that intent. As we enter the new year, now is the perfect time to launch Rain Oncology Inc. to reflect this unwavering mission," said Avanish Vellanki, Chief Executive Officer.

In connection with the name change, Rain will have a new corporate website at www.rainoncology.com. No action is required from current stockholders in connection with the name change. The company’s common stock will continue to be listed on The Nasdaq Global Select Market and the CUSIP will not change. The number of outstanding shares of the company’s common stock is not affected by the name change. The company’s ticker symbol "RAIN" will remain the same.

On December 29, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported its financial results for its fiscal year ended September 30, 2022, and provided recent corporate highlights (Press release, Outlook Therapeutics, DEC 29, 2022, View Source [SID1234625664]).

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Recent Corporate Highlights

Closed on approximately $50 million net proceeds from two new financings to support pre-launch activities through anticipated approval of ONS-5010 in third calendar quarter 2023.
Approximately $25 million registered direct equity offering priced at-the-market under Nasdaq rules.
Approximately $30 million net proceeds from issuance of an unsecured convertible promissory note with an initial conversion price of $2.00.
Received validation of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for ONS-5010/ LYTENAVA (bevacizumab-vikg).
Announced that the FDA accepted its Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg) for the treatment of wet AMD and set a PDUFA goal date of August 29, 2023.
Entered into a strategic commercialization agreement with AmerisourceBergen, a global healthcare company and leader in specialty pharmaceutical distribution and services who will provide third-party logistics (3PL) services and distribution, as well as medical information and pharmacovigilance services in the United States.
Strengthened Board of Directors with appointment of Julia Haller, MD, one of the country’s most accomplished professionals in ophthalmic education, research and clinical ophthalmic practice.
"Our fiscal year 2022 laid a solid foundation for what we believe will be a transformational 2023. We are driving our commercialization planning towards expected launch with the accepted FDA filing of our BLA for ONS-5010 and PDUFA date set for August 29, 2023, and review of our MAA in the EU underway with a decision date expected in early 2024. We believe that ONS-5010 has the potential to be a game-changer for patients and physicians in the retina community, and we now have the necessary capital to support these efforts. We remain steadfast in our mission to enhance the standard of care in the retinal anti-VEGF space," commented C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics. "On behalf of the entire team, I would like to thank all stakeholders for their continued support and look forward to what we believe will be an exciting future for Outlook Therapeutics."

Upcoming Anticipated Milestones

Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023;
PDUFA goal date of August 29, 2023; and
Estimated decision date from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on the Company’s submitted MAA in EU for ONS-5010 expected in early 2024.
ONS-5010 / LYTENAVA (bevacizumab-vikg) Pre-Launch Commercial Planning Underway

According to GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.

In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for the finished drug product.

Outlook Therapeutics is actively building out its sales and commercial team, and in September 2022, Outlook Therapeutics entered into a strategic commercialization agreement with AmerisourceBergen in preparation for the anticipated commercial launch in the United States of ONS-5010. As Outlook Therapeutics moves toward a potential launch in the United States, AmerisourceBergen’s commercialization support will expand to include additional services. Through the agreement with AmerisourceBergen, Outlook Therapeutics expects to significantly increase market access and efficient distribution of ONS-5010, if approved by the FDA. Moreover, working with AmerisourceBergen will help to provide Outlook Therapeutics with an accelerated pathway to deliver a high-quality customer experience to retina specialists. To bring ONS-5010 to market in a way that benefits all stakeholders – patients, clinicians, and payors – Outlook Therapeutics has also been in collaborative discussions with payors and the retina community.

Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and submitted them in December 2022. The formal review process of the MAA by the EMA’s CHMP is now set to begin with an estimated decision date expected in early 2024 and is also exploring a relationship with AmerisourceBergen to support the launch of ONS-5010 in international markets. AmerisourceBergen expanded its global distribution capabilities in 2021 with the acquisition of Alliance Healthcare, a leading wholesaler of healthcare products in Europe. Additionally, Outlook Therapeutics continues to explore potential strategic commercialization partners, such as the current partnership with Syntone Biopharma JV in China.

In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.

ONS-5010 / LYTENAVA (bevacizumab-vikg) Development Updates

As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application (sBLA) for approval to provide the product in a pre-filled, silicone oil liquid-free syringe that meets the FDA’s strict specifications for ophthalmic use. To support the anticipated submission of this sBLA, Outlook Therapeutics is conducting its NORSE SEVEN clinical trial to compare the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is expected to enroll approximately 120 subjects with visual impairment due to retinal disorders. Patients will be treated for three months; the enrollment of patients in the arm of the study receiving ONS-5010 in vials has already been completed.

Financial Highlights for the 2022 Fiscal Year Ended September 30, 2022

For the fiscal year ended September 30, 2022, Outlook Therapeutics reported a net loss attributable to common stockholders of $66.1 million, or $0.31 per basic and diluted share, compared to a net loss attributable to common stockholders of $53.2 million, or $0.35 per basic and diluted share, for fiscal 2021.

At September 30, 2022, Outlook Therapeutics had cash and cash equivalents of $17.4 million.

Subsequent to September 30, 2022, the Company closed a registered direct equity offering priced at-the-market under Nasdaq rules, resulting in aggregate gross proceeds of approximately $25.0 million. Additionally, the Company closed on an unsecured convertible promissory note (the "Note") with a face amount of $31.8 million and net proceeds of approximately $30.0 million after original issue discount and after deducting the Lender’s transaction costs covered by the Company in connection with the issuance. The combined proceeds from the Note and the registered direct offering are expected to provide funding through the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023.

About ONS-5010 / LYTENAVA (bevacizumab-vikg)

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.

Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

On December 29, 2022 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 the following year end update (Press release, Greenwich LifeSciences, DEC 29, 2022, View Source [SID1234625662]).

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SABCS Update & New Flamingo-01 Steering Committee

At the 2022 San Antonio Breast Cancer Symposium (SABCS), the Company met with the Flamingo-01 Steering Committee and met with clinicians from the US and various countries in Europe who are participating or planning to participate in Flamingo-01.

The Steering Committee is comprised of the following members and may be expanded as Flamingo-01 is expanded into Europe:

Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
Dr. Sara A. Hurvitz – Professor of Medicine at the David Geffen School of Medicine at UCLA, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit, Co-Director of the Santa Monica-UCLA Outpatient Oncology Practices, Director of the Breast Cancer Clinical Trials Program at UCLA, and Chief Medical Officer of TRIO-US
Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
Dr. Rimawi, Chair of the Steering Committee, commented, "We are excited about having initiated this trial. We believe that GP2 carries great potential to improve outcomes for patients with HER2 positive breast cancer. With growing interest and excitement about treatments that boost the immune response to cancer, this trial is as timely as it is innovative, and we look forward to conducting it with the exceptional team of investigators we will be collaborating with in Flamingo-01."

CEO Snehal Patel commented, "We were very encouraged by the meetings held at SABCS with clinicians who are participating in or interested in participating in Flamingo-01. The Company will continue to focus on opening more clinical sites than the 20 sites currently opened in the US, expanding Flamingo-01 into the largest countries in Europe, and enrolling and treating patients. We encourage potential patients to reach out to the clinical sites directly or to email the Company."

Clinical Sites Participating in Flamingo-01 Phase III Clinical Trial

Approximately 20 clinical sites with 63 locations at multiple hospitals and the largest oncology network in the US are currently recruiting patients. The Company has added a new page to its website to provide updates to Flamingo-01 which includes a map of participating clinical sites in the US (view here).

Patients who are interested in participating in the Flamingo-01 Phase III clinical trial can contact the Company by email at:

[email protected]

Patients can obtain the latest clinical site contact information to contact sites directly on www.clinicaltrials.gov with identifier NCT05232916 (view here, then click on "Contacts and Locations" near the top right corner or near the bottom of the web page). The current listing of US sites from www.clinicaltrials.gov with email contact information for some sites is also shown below and will be continually updated during the trial:

Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Principal Investigator: Erica Stringer-Reasor, MD

Arizona

Arizona Oncology Associates, PC – HOPE

Tucson, Arizona, United States, 85745

Contact: Stacey Kimbell, R.N. [email protected]

Principal Investigator: Aisha Ahmed, MD

California

University of Southern California

Los Angeles, California, United States, 90033

Principal Investigator: Danielle Sterrenberg, MD

University of California, Los Angeles

Los Angeles, California, United States, 90404

Principal Investigator: Sara Hurvitz

Torrance Memorial Physicians Network

Torrance, California, United States, 90505

Principal Investigator: David Chan, MD

PIH Hospital – Whittier

Whittier, California, United States, 90602

Principal Investigator: Lisa Wang, MD

Colorado

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80220

Principal Investigator: Mabel Mardones, MD

Florida

University of Miami

Coral Gables, Florida, United States, 33146

Principal Investigator: Mauricio Escobar, MD

Orlando Health Cancer Institute

Orlando, Florida, United States, 32806

Principal Investigator: Nikita Shah, MD

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Principal Investigator: Aixa Soyano, MD

Maryland

Maryland Oncology Hematology (USOR)

Annapolis, Maryland, United States, 21401

Principal Investigator: Jeanine Werner, MD

Nebraska

Nebraska Cancer Specialists (USOR)

Omaha, Nebraska, United States, 68114

Contact: Heather Cordes [email protected]

Principal Investigator: Mary Wells, MD

Nevada

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States, 89052

Principal Investigator: Stephani Christensen, MD

New York

Columbia University

New York, New York, United States, 10032

Contact: [email protected]

Principal Investigator: Julia McGuinness, MD

Stony Brook University

Stony Brook, New York, United States, 11794

Principal Investigator: Jules Cohen, MD

Oregon

Compass Oncology (USOR)

Tigard, Oregon, United States, 97223

Contact: Jennifer Thompson [email protected]

Principal Investigator: Jay Andersen, MD

Texas

Texas Oncology – Austin

Austin, Texas, United States, 78745

Contact: Sara Manning [email protected]

Principal Investigator: Debra A Patt, MD

Texas Oncology – Dallas (USOR)

Dallas, Texas, United States, 75246

Contact: Christine Terraciano [email protected]

Principal Investigator: Cynthia Osborne, MD

Baylor College of Medicine

Houston, Texas, United States, 77057

Contact: Mothaffar Rimawi, MD

Principal Investigator: Mothaffar Rimawi, MD

Texas Oncology San Antonio (USOR)

San Antonio, Texas, United States, 78240

Contact: Shannon Syring [email protected]

Principal Investigator: Emmalind Aponte, MD

Texas Oncology – Tyler (USOR)

Tyler, Texas, United States, 75702

Principal Investigator: Nanna Sulai, MD

Virginia

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Principal Investigator: Shruti Tiwari, MD

The Colorado and Alabama sites listed above are not yet recruiting. An additional 10 sites near the following locations may be activated in the future: San Francisco, Boston, Chicago, Philadelphia, Houston, Cincinnati, Albany, Dallas, Omaha, and New Haven. Negotiations are under way to add an additional 60-75 sites in Europe, bringing the total number of potential sites in Flamingo-01 to over 90 sites.

Flamingo-01 Enrollment & Open Label Data

Future updates or abstracts/posters may include the patient enrollment status of the trial and potentially open label data results.

Mr. Patel further added, "We look forward to analyzing open label data, which may include injection site reactions, delayed type hypersensitivity testing, and immune response data as they become available by HLA type. The objective, although there is no assurance that any of this will be possible, is to assess how Flamingo-01 is progressing compared to the Phase IIb trial, where no recurrences were observed in the GP2 treated patients as previously reported. Along the way, the treatment of patients of different HLA types and the use of new T cell identification technologies may provide additional insights into GP2’s mechanism of action and market potential, including potential additional intellectual property for the Company."

Commercial Manufacturing & New Intellectual Property

In the fourth quarter of 2022, the Company initiated commercial manufacturing activities, which, if successful, would lead to the completion of the first 3 commercial lots of GP2 active ingredient in 2023 and which in total could be used to prepare approximately 200,000 doses of GP2. These commercial lots would be submitted to the FDA in the US and other regulatory agencies in Europe when a marketing application is filed seeking approval to sell GP2 in these respective locations.

In the fourth quarter of 2022, a new patent application was filed with regards to the use of GP2 in an immune response assay that could be used as a biomarker. Plans are in place to potentially file additional patent applications with regards to the use of GP2 in treating patients and with regards to GP2 manufacturing, pharmacy, or injection processes.

IR Calendar, Bloomberg Interview, & Updated Corporate Presentation Webcast

The Company’s events over the past 6 months can be seen on the events calendar (view here), which include Jefferies and Wainwright investor conferences, BIO Europe partnering conference, Susan G. Komen Race for Cure, and an interview of CEO Patel aired on Bloomberg (view here). The corporate presentation has also been updated, and the webcast will be updated shortly (view here).

About Flamingo-01 and GLSI-100

Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, 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.

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 29, 2022 F-star Therapeutics, Inc. (the "F-star") reported the following update regarding its Agreement and Plan of Merger, dated as of June 22, 2022, as amended (the "Merger Agreement"), by and among, the Company, invoX Pharma Limited ("invoX"), Fennec Acquisition Incorporated, a wholly owned subsidiary of invoX ("Fennec" and together with the F-star and invoX, the "Parties"), and Sino Biopharmaceutical Limited, as guarantor ( "Sino Biopharm") (Filing, 8-K, F-star, DEC 29, 2022, View Source [SID1234625661]):

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Effective at December 29, 2022 at 12:05 a.m. Eastern Time, the Committee on Foreign Investment in the United States ("CFIUS") issued an order (the "Interim Order") preventing the consummation of the transactions pursuant to the Merger Agreement, citing unresolved national security risks. The Interim Order also prohibits (1) the transfer, lease, license, sale, or otherwise acquisition of any asset or affiliate of F-star to Sino Biopharm, invoX, or any of their affiliates, or (2) the transfer, lease, license, sale, or acquisition otherwise of any securities, equity, or other ownership interests or rights in F-star or any affiliate of F-star, including any rights to acquire any of the foregoing, by Sino Biopharm, invoX, Fennec, or any affiliates of any of the foregoing, including through merger.

The Interim Order is for an indeterminate duration, lasting until: (1) CFIUS concludes action under Section 721 with respect to the transaction; (2) the President of the United States ("President") takes action or declines to take action under Section 721 with respect to the transaction; or (3) CFIUS or the President revokes or terminates this Interim Order.

The purpose of the Interim Order is to provide CFIUS adequate opportunity to continue its review and investigation. The Parties may provide CFIUS with additional relevant information and CFIUS will consider such information, including information regarding the Interim Order or proposals to mitigate the identified national security risks.

As described below, the extension of the tender offer enables the Parties to have additional time for discussions with CFIUS regarding the Interim Order and to evaluate whether mitigation steps can be taken to permit the timely closing of the transactions contemplated by the Merger Agreement. Previously, CFIUS had confirmed to the Parties that it had determined that mitigation measures would be available. However, other than outlining some core attributes of such mitigation, CFIUS had provided no specific information, had indicated its views were preliminary, and had not indicate a timetable for its determination of any specific requirements to be imposed.

Tender Offer Extended Until 5 p.m. Eastern Time on Friday December 30, 2022

On December 29, 2022, invoX, Fennec, and Sino Biopharm extended the Offer to 5:00 p.m., Eastern Time, on December 30, 2022. The End Date, as defined in the Merger Agreement, is one (1) minute past 11:59 p.m., Eastern Time, on December 30, 2022. As previously described, the Merger Agreement may be terminated by either party, subject to certain exceptions, if any of the Offer conditions, are not satisfied or waived, to the extent waiveable, by Purchaser on or before the End Date. The foregoing provides the Parties additional time to have discussions with CFIUS regarding the Interim Order and to evaluate any next steps.

The Offer was previously set to expire at one (1) minute past 11:59 p.m., Eastern Time, on December 28, 2022. As of such time, the Depositary had advised that Shares representing approximately 76% of the outstanding Shares had been validly tendered into and not properly withdrawn from the Offer.

On December 28, 2022, NeuBase Therapeutics, Inc. (the "Company") reported to have entered into a Purchase Agreement (the "Purchase Agreement") with Alumni Capital LP, a Delaware limited partnership ("Alumni Capital"), pursuant to which the Company agreed to sell, and Alumni Capital agreed to purchase, upon request of the Company in one or more transactions, a number of shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock") providing aggregate gross proceeds to the Company of up to $3,000,000 (subject to the right, but not the obligation, of the Company to increase such amount up to $10,000,000 pursuant to the terms of the Purchase Agreement) (the "Maximum Investment Amount") (Filing, NeuBase Therapeutics, DEC 28, 2022, View Source [SID1234625689]). The Purchase Agreement expires upon the earlier of the aggregate gross proceeds from the sale of shares of Common Stock meeting the Maximum Investment Amount or December 28, 2024.

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Among other limitations, unless otherwise agreed upon by Alumni Capital, each individual sale of shares of Common Stock will be limited to a sale of shares of Common Stock of up to $500,000 (subject to the right of the Company and Alumni Capital to mutually agree to increase such figure to $1,000,000) and further limited to no more than the number of shares of Common Stock that would result in the direct or indirect beneficial ownership by Alumni Capital of more than 9.99% of the then-outstanding shares of Common Stock. Alumni Capital will purchase the shares of Common Stock under the Agreement at the lowest traded price of the Common Stock during the three (3) business days immediately prior to the date of purchase of the shares of Common Stock multiplied by 95%. In addition, the total cumulative number of shares of Common Stock that may be issued to Alumni Capital under the Purchase Agreement may not exceed the requirements of Nasdaq Listing Rule 5635(d), except that such limitation will not apply in the event the Company obtains stockholder approval of the shares of Common Stock to be issued under the Purchase Agreement, if necessary, in accordance with the requirements of Nasdaq Listing Rule 5635(d).

In exchange for Alumni Capital entering into the Purchase Agreement, the Company issued 146,699 shares of Common Stock to Alumni Capital upon execution of the Purchase Agreement. The Company will issue to Alumni Capital, on December 28, 2023, shares of Common Stock in an amount equal to one-half of one percent (0.5%) of the Investment Amount (as defined in the Purchase Agreement) divided by the closing price of the Common Stock on the third business day prior to the date of issuance and delivery of such shares of Common Stock. In addition, the Company will issue to Alumni Capital, on the date of expiration of the Purchase Agreement, shares of Common Stock in an amount equal to one-half of one percent (0.5%) of the Investment Amount divided by the closing price of the Common Stock on the third business day prior to the date of issuance and delivery of such shares of Common Stock. If the Company elects to increase the Maximum Investment Amount, it shall issue to Alumni Capital Increase Commitment Shares (as defined in the Purchase Agreement) (based on each increase of Investment Amount) within five (5) business days of the Company’s written notice of such election.

The Purchase Agreement provides that the Company will file a prospectus supplement (the "Prospectus Supplement") to its Registration Statement on Form S-3, which was declared effective on April 14, 2021 (File No. 333-254980) (the "Base Registration Statement"), covering the offering and sale of the shares of Common Stock to Alumni Capital pursuant to the Purchase Agreement. Alumni Capital’s obligation to purchase shares of Common Stock under the Purchase Agreement is conditioned upon, among other things, the filing of the Prospectus Supplement and the Base Registration Statement remaining effective.

The Purchase Agreement contains customary representations, warranties and covenants by each of the Company and Alumni Capital. Actual sales of shares of Common Stock to Alumni Capital will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. Alumni Capital has no right to require any sales of shares of Common Stock by the Company, but is obligated to make purchases of shares of Common Stock from the Company from time to time, pursuant to directions from the Company, in accordance with the Purchase Agreement. During the term of the Purchase Agreement, Alumni Capital has covenanted not to cause or engage in any short selling of shares of Common Stock.

This Current Report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock 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 other jurisdiction.

The net proceeds under the Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of Common Stock to Alumni Capital. The Company expects that any proceeds received by the Company from such sales of shares of Common Stock to Alumni Capital under the Purchase Agreement will be used for general corporate and working capital purposes.

The foregoing summary of the Purchase Agreement is qualified in its entirety by reference to the complete agreement, a copy of which is attached hereto as Exhibit 10.1 and incorporated herein by reference. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to the Purchase Agreement, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Purchase Agreement is incorporated herein by reference only to provide investors with information regarding the terms of the Purchase Agreement, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Securities and Exchange Commission.