On May 20, 2024 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported the opening of its proposed $100 million tender offer (the "Tender Offer") (Press release, PureTech Health, MAY 20, 2024, View Source [SID1234643460]).

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!

Tender Offer Highlights

•
The Tender Offer opens today 20 May 2024. Subject to the terms and conditions of the Tender Offer, the Company will purchase for cash a maximum of $100 million in value of ordinary shares of one pence each in the capital of the Company ("Ordinary Shares") (including Ordinary Shares represented by the Company’s American Depositary Shares each representing 10 Ordinary Shares ("ADSs")).

•
The Tender Offer for the Company’s Ordinary Shares will close at 1:00 p.m. London time on Thursday 20 June 2024 (the "Ordinary Share Closing Date"), and the Tender Offer for the Company’s ADSs will close at 5:00 p.m. New York City time on Tuesday 18 June 2024 (the "ADS Closing Date"), unless the Tender Offer is extended.

•
The Company is offering to purchase up to 33,500,000 Ordinary Shares (including Ordinary Shares represented by ADSs) representing approximately 12 percent of the Company’s issued ordinary share capital as at 16 May 2024 (being the latest practicable date before publication of this announcement ("Latest Practicable Date")) at a fixed price of 250 pence per Ordinary Share (equivalent to £25.00 per ADS) (the "Tender Price") up to a maximum aggregate amount of $100 million. The maximum amount of $100 million will be translated into a pounds sterling amount on the Ordinary Share Closing Date, and that pounds sterling amount shall determine the maximum number of shares to be accepted for payment in the Tender Offer.

•
The Tender Price represents a premium of 25 percent to PureTech’s trailing volume weighted average price per Ordinary Share over the three days prior to 19 March 2024, the date of the Company’s initial announcement of the Tender Offer proposals and a premium of 12.6 percent to the closing price of 222 pence per Ordinary Share on the Latest Practicable Date.

•
If the full $100 million is not returned through the Tender Offer, then, if there is sufficient surplus, the Company’s board of directors ("Board") intends to return such surplus by way of a special dividend following completion of the Tender Offer, without interest, less any applicable withholding taxes and subject to market and industry conditions at the time and any relevant legal restrictions (the "Special Dividend").

•
Completion of the Tender Offer will be conditional, among other things, on shareholder approval at a general meeting of the Company to be held at 11:00 a.m. New York City time (4:00 p.m. London time) on 6 June 2024 at the Company’s offices at 6 Tide Street, Boston, Massachusetts, 02210, United States (the "General Meeting").

•
Full details of the Tender Offer are included in a circular to the Company’s Shareholders (the "Circular") which will be mailed to Shareholders and ADS Holders today and available on a website set up by the Company for the purposes of the Tender Offer. The website is available at View Source Copies of the Circular will be submitted to the National Storage Mechanism and will be available for inspection at View Source The Circular will also be included as an exhibit to the Schedule TO to be filed with the Securities and Exchange Commission and will be available for inspection at View Source

•
SHAREHOLDERS AND ADS HOLDERS ARE ADVISED TO CONSULT WITH THEIR PROFESSIONAL TAX ADVISORS IN CONNECTION WITH CERTAIN US FEDERAL WITHHOLDING TAX CONSIDERATIONS DESCRIBED IN FURTHER DETAIL BELOW (SEE "Certain US Federal Income Tax Considerations with Respect to the Tender Offer").

Structure of the Tender Offer

The Tender Offer will be implemented on the basis of Jefferies International Limited ("Jefferies") acquiring, as principal, the successfully tendered Ordinary Shares (including Ordinary Shares represented by ADSs) at the Tender Price. In turn, Jefferies has the right to require the Company to purchase such Ordinary Shares (including Ordinary Shares represented by ADSs) from it at the same Tender Price pursuant to an option agreement entered into between the Company and Jefferies (the "Option Agreement"). If Jefferies does not exercise its right to require the Company to purchase such Ordinary Shares (including Ordinary Shares represented by ADSs), the Company has the right to require Jefferies to sell such Ordinary Shares (including Ordinary Shares represented by ADSs) to it at the same price. The Company intends to cancel the Ordinary Shares (including Ordinary Shares represented by ADSs) purchased by it pursuant to the Tender Offer.

Shareholders can decide whether they want to tender all, some or none of their Ordinary Shares or ADSs in the Tender Offer.

If the aggregate value at the Tender Price of all validly tendered Ordinary Shares (including Ordinary Shares represented by ADSs) exceeds $100 million (based on the applicable exchange rate of US dollars to pounds sterling on the Ordinary Share Closing Date) or the number of validly tendered Ordinary Shares (including Ordinary Shares represented by ADSs) exceeds 33,500,000 Ordinary Shares, then not all of the Ordinary Shares (including Ordinary Shares represented by ADSs) validly tendered will be accepted and purchased. In these circumstances, tenders will be scaled down pro-rata to the total number of Ordinary Shares (including Ordinary Shares represented by ADSs) so tendered by that shareholder, such that the total cost of Ordinary Shares (including Ordinary Shares represented by ADSs) purchased pursuant to the Tender Offer does not exceed $100 million or the total number of validly tendered Ordinary Shares (including Ordinary Shares represented by ADSs) does not exceed 33,500,000 Ordinary Shares.

Certain US Federal Income Tax Considerations with Respect to the Tender Offer

Shareholders and ADS Holders should consult their professional tax advisors in connection with the Tender Offer.

Shareholders and ADS Holders should note that, due to the circumstances of its formation and the application of Section 7874 of the United States Internal Revenue Code of 1986, as amended ("Code"), the Company is treated as a US domestic corporation for US federal income tax purposes. Accordingly, the Company is subject to US federal income tax as if it were a US corporation, and distributions made by the Company (including certain payments in respect of the Tender Offer that are treated as distributions for US federal income tax purposes) are generally treated as US-source dividends, as if the Company were incorporated in the US. As a result, both US Holders and Non-US Holders (each as defined in the Circular) may be subject to US federal income tax withholding on receipt of cash proceeds from any tendered Ordinary Shares or ADSs accepted in the Tender Offer and the Special Dividend (if any).

The attention of Shareholders and ADS Holders is drawn to Part VI of the Circular, which provides a summary of certain material UK tax and US federal income tax consequences for Shareholders and ADS Holders of accepting the Tender Offer or receipt of the Special Dividend (if any).

All Shareholders and ADS Holders should receive a Section 302 Certification. Copies of the Section 302 Certification, IRS Form W-9, and IRS Forms W-8, as well the IRS instructions with respect to such IRS Forms, are also available on the Microsite set up by the Company for the purposes of the Tender Offer. The Microsite is available at View Source

In consultation with their professional tax advisors regarding their individual circumstances, Shareholders and ADS Holders should complete the Section 302 Certification and an IRS Form W-9 or applicable IRS Form W-8, as applicable, in accordance with the instructions thereon. Shareholders and ADS Holders should return the properly completed Section 302 Certification and the IRS Form W-9 or applicable IRS Form W-8, as applicable, in accordance with the instructions set forth the Circular, the Tender Form, the Letter of Transmittal and the Section 302 Certification, as applicable. Part VI of the Circular also provides additional information to Shareholders and ADS Holders on the process for returning a Section 302 Certifications and an IRS Form W-9 or applicable IRS Forms W-8, as applicable.

The appropriate IRS Form W-9 or Form W-8 should be returned whether or not a Shareholder plans to participate in the Tender Offer, if not previously provided. IRS Form W-9 and IRS Form W-8 will also be relevant in connection with the Special Dividend (if any).

This information is not tax advice, and the Company cannot advise you with respect to taxes. Shareholders and ADS Holders should consult their professional tax advisors, in particular regarding their individual tax position and the exemptions or reductions of US withholding tax that may be available to them. For more information, Shareholders and ADS Holders should read the full text of this announcement of the Tender Offer, the Circular, the Tender Form, and the Letter of Transmittal.

General Meeting

Implementation of the Tender Offer is conditional upon, amongst other things, the approval of the shareholders of the resolution necessary to implement the Tender Offer (the "Resolution"). For this purpose, the Company is convening the General Meeting for 11 a.m. New York City time (4 p.m. London time) on 6 June 2024 to be held at 6 Tide Street, Boston, Massachusetts, 02210, United States to consider and, if thought fit, pass the Resolution to approve the terms on which the Tender Offer will be effected. A notice convening the General Meeting is set out at the end of the Circular.

Participating in the Tender Offer

If you are a Shareholder and hold your Ordinary Shares in Certificated Form and you wish to tender all or any of your Ordinary Shares, you should complete the Tender Form in accordance with the instructions printed on it and in Part V of the Circular and return it by post in the accompanying reply-paid envelope (for use in the UK only) to the Receiving Agent, at the Pavilions, Bridgewater Road, Bristol, BS99 6AH so as to be received by no later than 1:00 p.m. (London time) on Thursday 20 June 2024, together with your share certificate(s) in respect of the Ordinary Shares tendered.

If you are a Shareholder and hold your Ordinary Shares in Uncertificated Form and you wish to tender all or any of your Ordinary Shares, you should send the TTE Instruction through CREST so as to settle by no later than 1:00 p.m. (London time) on Thursday 20 June 2024.

Any ADS Holder who holds ADSs on the books of the Depositary who wishes to tender pursuant to the Tender Offer should properly complete and duly execute a Letter of Transmittal (or facsimile thereof), together with any required signature guarantees and any other required documents, and deliver such documents to the tender agent for the ADSs, Citibank, N.A. (the "Tender Agent"), at the appropriate address set forth in the Letter of Transmittal so as to be received no later than 5:00 p.m. (New York City time) on the ADS Closing Date (unless the Tender Offer is extended). In addition, the ADRs evidencing the tendered ADSs must be received by the Tender Agent at the appropriate address or be delivered pursuant to the procedures for book-entry transfer set forth below (and a confirmation of receipt of such transfer must be received by the Tender Agent) so as to be received no later than 5:00 p.m. (New York City time) on the ADS Closing Date.

If the ADSs are held through a broker, dealer, commercial bank, trust company or other securities intermediary and the ADS Holder wishes to participate in the Tender Offer, such ADS Holder should provide tender instructions in accordance with the instructions provided by such intermediary in sufficient time so as to ensure that such intermediary can provide such instructions to the Tender Agent so as to be received no later than 5:00 p.m. (New York City time) on the ADS Closing Date (unless the Tender Offer is extended).

Timetable

A summary expected timetable of principal events is set out in Appendix I to this announcement.

On May 20, 2024 Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) reported that it has been invited to present PTX-100 Phase 1b results at the 15th Annual T-Cell Lymphoma Forum (TCLF) to be held in California from June 6 to 8 (Press release, Prescient Therapeutics, MAY 20, 2024, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-to-present-ptx-100-results-at-t-cell-lymphoma-forum-in-california [SID1234643459]).

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!

Primary goals met
The Phase 1b study of PTX-100, which targeted patients with relapsed and refractory T-cell lymphomas (r/r TCLs), has met its primary goals of demonstrating safety and determining both pharmacokinetics – how the drug is absorbed, distributed, metabolised and excreted in the body – and pharmacodynamics, or the effects of the drug on the body.

Additionally, the study has shown promising preliminary efficacy in r/r TCL patients, surpassing the typical results expected from standard treatments, with an overall response rate of 45%.

This means that five out of 11 evaluable TCL patients responded positively to the treatment.

Orphan disease designation
T-cell lymphomas (TCLs) are a type of non-Hodgkin lymphoma that originates from T-cells, a kind of white blood cell.

TCLs are considered an orphan disease, which means they are rare, with around 30,000 cases. There is a significant need for more effective treatments for TCLs, especially for those with relapsed and refractory disease.

Accordingly, PTX-100 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA), a status given to drugs intended for the treatment of rare diseases.

The 15th annual T-Cell Lymphoma Forum (TCLF) is a specialised conference focusing on the latest and most significant advancements in T-cell lymphomas, including new agents and treatment approaches.

It brings together clinicians, scientists and industry professionals dedicated to TCLs.

The PTX-100 study results will be presented in a plenary address by the study’s Principal Investigator, Professor H. Miles Prince, AM, a distinguished haematologist and globally recognized expert in TCLs.

Esteemed platform
Prescient Therapeutics managing director and CEO Steven Yatomi-Clarke said: "The TCLF is an esteemed platform for sharing the latest research and developments in the field of TCLs.

"To be invited to present our data in a coveted slot to world leaders in the field of TCLs showcases the relevance and potential of PTX-100 in this area of unmet need.

"It also highlights the momentum and standing that Prescient has in this specialised community of TCL clinicians and drug developers, having previously presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 65th Annual Meeting and the 5th World Congress of Cutaneous Lymphomas.

"Prescient is committed to advancing into a Phase 2 trial in r/r TCL, with the study aiming to commence in Q3 2024. The company believes this will be a big catalyst for Prescient, potentially offering a new beacon of hope for patients with limited treatment options."

On May 20, 2024 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, reported an update on the Company’s recent activities, including notable pre-clinical developments (Press release, Lixte Biotechnology, MAY 20, 2024, View Source [SID1234643458]).

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!

"LIXTE continues to make progress with its proprietary compound, LB-100, in ongoing clinical trials for lung, ovarian and sarcoma cancers," said Bas van der Baan, LIXTE’s President and Chief Executive Officer. "We also are pleased with the findings of recent pre-clinical data with LB-100 in an entirely new field of cancer biology — activation lethality — that we believe has outstanding potential in advancing new treatment options."

Recent Company highlights include:

● Pre-clinical studies in a new field of cancer biology — activation lethality — have shown that LB-100 can force cancer cells to give up their cancer-causing properties. The findings open a potentially new treatment strategy in addition to LIXTE’s current three ongoing clinical trials. René Bernards, Ph.D., a leader in the field of molecular carcinogenesis and Senior Staff Scientist at the Netherlands Cancer Institute, presented the new pre-clinical data at the Joint Conference of European and American Associations for Cancer Research in Dublin, Ireland. The paper, "Paradoxical Activation of Oncogenic Signaling as a Cancer Treatment Strategy," was posted in the online medical journal Cancer Discovery on April 30, 2024. Dr. Bernards is a member of LIXTE’s Board of Directors.

● Bas van der Baan, LIXTE’s President and Chief Executive Officer, presented at the MedInvest Biotech and Pharma Investor Conference on April 3, 2024 in New York City. The two-day event featured presentations from more than 40 companies, developing and commercializing technologies across a broad spectrum of indications, including oncology. The conference also featured talks from key industry opinion leaders, investor panel discussions, and conversations with the National Cancer Institute on patenting, facilitating collaborations, licensing and technology analysis and marketing.

● LIXTE co-sponsored an international scientific workshop on "Therapeutic Over-Activation in Cancer" at Harvard University’s Dana Farber Cancer Institute in Boston, Massachusetts on May 9 and 10, 2024. The workshop brought together leading experts from the pharmaceutical industry and academia who discussed a radically different approach to cancer therapy that is being spearheaded by LIXTE’s outsourced research team at the Netherlands Cancer Institute.

LIXTE has clinical trials underway at the University of Texas MD Anderson Cancer (ovarian clear cell carcinoma); City of Hope Cancer Center and the Sarah Cannon Research Institute (small cell lung cancer); and the Spanish Sarcoma Group (advanced soft tissue sarcoma). In February 2024, LIXTE signed an exclusive patent license agreement with the National Institute of Neurological Disorders and Stroke (NINDS) and the National Cancer Institute (NCI), each an institute or center of the National Institute of Health (NIH).

Click here for a brief video overview by LIXTE’s Chief Executive Officer.

Filing of Quarterly Report on Form 10-Q for the three months ended March 31, 2024

Additional information with respect to LIXTE’s business, clinical trials and financial condition is contained in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, which has been filed with the U.S. Securities and Exchange Commission at www.sec.gov.

On May 20, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported that UPMC in Pittsburgh, Pennsylvania has been activated as the fourth clinical trial site in the Deltacel-01 Phase 1 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) (Press release, Kiromic, MAY 20, 2024, View Source [SID1234643457]).

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!

UPMC is a world-renowned healthcare system that employs some of the nation’s top clinicians and medical researchers. UPMC Hillman Cancer Center is Western Pennsylvania’s only National Cancer Institute-designated Comprehensive Cancer Center.

The lead principal investigator for Deltacel-01, Jason J. Luke, MD, FACP, will also serve as principal investigator at the UPMC site. Dr. Luke is Associate Professor of Medicine at the University of Pittsburgh and UPMC Hillman Cancer Center, where he is Associate Director for Clinical Research and Director of the Immunotherapy and Drug Development Center.

"We’re delighted to have Dr. Jason Luke and UPMC participating in the conduct of research of our potentially transformative therapy. Dr. Luke is one of the world’s foremost investigators in immuno-oncology, having led clinical trials of immunotherapies across many cancer types. His expertise in early phase drug development for solid tumors has played a critical role in shaping our trial, and we are optimistic Deltacel will demonstrate continued favorable outcomes in this deadly disease as we expand treatment to patients across more sites. We expect to activate one more clinical trial site later this quarter and to begin enrolling patients at UPMC this summer," said Pietro Bersani, Chief Executive Officer of Kiromic.

Kiromic also announces favorable preliminary safety and tolerability data from the fourth patient in Deltacel-01, with early efficacy data on this patient expected by the end of May. The fifth and sixth patients are expected to be enrolled later in May and June, respectively.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On May 20, 2024 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported that it has entered into a securities purchase agreement with a single institutional investor to purchase 1,672,452 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Inhibikase Therapeutics, MAY 20, 2024, View Source [SID1234643456]). In a concurrent private placement, the Company also agreed to issue unregistered Series A warrants to purchase up to an aggregate of 1,672,452 shares of common stock, and unregistered Class B warrants to purchase up to an aggregate of 1,672,452 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold with one Series A warrant to purchase one share of common stock and one Series B warrant to purchase one share of common stock at a combined purchase price of $1.68. The Series A and Series B warrants will each have an exercise price of $1.68 per share, will be exercisable beginning on the effective date of stockholder approval and, in the case of Series A warrants, will expire on the one-year anniversary from the date of stockholder approval, and in the case of Series B warrants, will expire on the five-year anniversary from the date of stockholder approval.

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 Company has also entered into a warrant inducement agreement with the investor to exercise certain outstanding warrants that the Company issued in January 2023. Pursuant to the warrant inducement agreement, the investor has agreed to exercise outstanding warrants to purchase an aggregate of 708,500 shares of the company’s common stock at an amended exercise price of $1.68. In consideration for the immediate exercise of the warrants, the Company also agreed to reduce the exercise price of the remaining unexercised portion of such warrants to purchase 1,229,484 shares of common stock to $1.68, and to issue the investor unregistered Series C warrants to purchase an aggregate of 708,500 shares of the Company’s common stock, and Series D warrants to purchase an aggregate of 708,500 shares of the Company’s common stock. The Series C and Series D warrants will each have an exercise price of $1.68 per share, will be exercisable beginning on the effective date of stockholder approval and, in the case of Series C warrants, will expire on the one-year anniversary from the date of stockholder approval, and in the case of Series D warrants, will expire on the five-year anniversary from the date of stockholder approval.

The gross proceeds to the Company from the registered direct offering, concurrent private placement and warrant inducement are estimated to be approximately $4.0 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company. The offering is expected to close on or about May 22, 2024, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The shares of common stock (or pre-funded warrants in lieu thereof) are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-262551), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on February 11, 2022. The warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act") under Section 4(a)(2) thereof and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock and pre-funded warrants will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3500.