Agios to Present at the RBC Capital Markets Global Healthcare Conference on May 14, 2024

On May 3, 2024 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the company is scheduled to present at the 2024 RBC Capital Markets Global Healthcare Conference on Tuesday, May 14, 2024, at 8:00 a.m. ET (Press release, Agios Pharmaceuticals, MAY 3, 2024, View Source [SID1234642624]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

Abeona Therapeutics Announces Pricing of $75 Million Underwritten Offering of Common Stock and Pre-Funded Warrants

On May 3, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) ("Abeona" or the "Company") reported the pricing of an underwritten offering of 12,285,056 shares of its common stock and, in lieu of common stock, pre-funded warrants to purchase 6,142,656 shares of its common stock, at an offering price of $4.07 per share, which is equal to the closing price on Thursday, May 2, 2024, or $4.0699 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Abeona Therapeutics, MAY 3, 2024, View Source [SID1234642623]). The pre-funded warrants will be immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the pre-funded warrants are exercised in full. The closing of the offering is expected to occur on or about May 7, 2024, subject to the satisfaction of customary closing conditions.

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The offering included participation from both new and existing investors, including Adage Capital Partners, L.P., Janus Henderson Investors, Nantahala Capital, Suvretta Capital, Vivo Capital, and other healthcare-dedicated investors.

Stifel is acting as the sole bookrunner for the offering.

The gross proceeds to Abeona from this offering are expected to be approximately $75 million, before deducting underwriting discounts and commissions and other offering expenses. Abeona intends to use the net proceeds from the offering primarily to fund preparations for resubmission of its BLA and for commercialization of its product candidate pz-cel, as well as for working capital and general corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256850) that was filed with the Securities and Exchange Commission (the "SEC") on June 7, 2021 and amended on August 27, 2021 and October 19, 2021, and was declared effective by the SEC on October 22, 2021. When available, the prospectus supplement and the accompanying prospectus that form a part of the registration statement will be filed with the SEC and available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained when available by contacting Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Abeona being offered, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Clarity to present at three world leading conferences

On May 3, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that new data will be presented at the upcoming AUA, ASCO (Free ASCO Whitepaper) and SNMMI 2024 Annual Meetings, covering clinical results and trials in progress (Press release, Clarity Pharmaceuticals, MAY 3, 2024, View Source [SID1234642582]). The data showcases the extensive scope of Clarity’s Targeted Copper Theranostic (TCT) platform in developing multiple products for imaging and treating cancer patients, with focus on prostate cancer.

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Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The AUA, ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings are among the most prestigious conferences in urology, oncology and nuclear medicine, respectively. We are delighted that our data has been accepted for presentation at these world leading conferences. The abstracts accepted for presentations, including two oral presentations, highlight the exciting opportunities for our next-generation TCT radiopharmaceuticals as we continue to generate incredible data on what we strongly believe to be best in class assets for the treatment and diagnosis of cancer.

"We are looking forward to sharing this data as we continue to adhere to the highest standards of clinical research, work with world-class clinical sites and generate exciting results to date while expanding the platform into multiple indications. We are also looking forward to further developing our existing as well as novel TCT products as we get closer to our ultimate goal of improving treatment outcomes for children and adults with cancer."

Data to be presented at 2024 AUA, ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings
Product Abstract Title Conference
64Cu-SAR-bisPSMA CLARIFY: Positron Emission Tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy, a phase 3 diagnostic study AUA – Oral presentation
Session Date
Sunday, May 5th

Session Time
1:00-3:00 PM CT

Session Title
Clinical Trials in Progress—Cancer

64Cu-SAR-bisPSMA COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy ASCO – Poster presentation
Session Date
Sunday, June 2nd

Session Time
9:00 AM – 12:00 PM CT

Session Title/Track
Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track
Prostate Cancer–Local-Regional Disease

Abstract # 5100

Poster Bd # 506

64Cu-SAR-bisPSMA CLARIFY: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy (a phase 3 diagnostic study) ASCO – Poster presentation
Session Date
Sunday, June 2nd

Session Time
9:00 AM – 12:00 PM CT

Session Title/Track
Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track
Prostate Cancer–Local-Regional Disease

Abstract # TPS5129

Poster Bd # 524a

67Cu-SAR-bisPSMA SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer

ASCO – Poster presentation
Session Date
Sunday, June 2nd

Session Time
9:00 AM – 12:00 PM CT

Session Title/Track
Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track
Prostate Cancer– Advanced/Castrate-Resistant

Abstract # TPS5116

Poster Bd # 517b

64Cu-SAR-bisPSMA COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy SNMMI – Oral presentation
Session Date
Tuesday, June 11th

Session Time
8:00 AM – 9:15 AM ET

Session Title
Prostate Cancer – Radiomics/Data Analysis

67Cu-SAR-bisPSMA SECuRE: A dose escalation/expansion study to assess the anti-tumor efficacy of 67Cu-SAR-bisPSMA in patients with metastatic castrate resistant prostate cancer SNMMI – Poster presentation
67Cu-SAR-BBN COMBAT: A study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for identification and treatment of GRPr-expressing metastatic castrate resistant prostate cancer ineligible for therapy with 177Lu-PSMA-617 SNMMI – Poster presentation
64Cu-SAR-BBN SABRE: Assessment of safety and efficacy of 64Cu-SAR-BBN in PSMA-negative biochemical recurrent prostate cancer patients SNMMI – Poster presentation
Posters and presentations containing study results will be available on Clarity’s official website after their presentation at the 2024 AUA, ASCO (Free ASCO Whitepaper) and SNMMI Annual Meetings: claritypharmaceuticals.com/pipeline/scientific_presentations

Abstracts for the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting will be released on the 23rd of May at 5 PM ET and will be available at the conference website: conferences.asco.org/am/abstracts

Galapagos reports first quarter 2024 financial results

On May 2, 2024 Galapagos NV (Euronext & NASDAQ: GLPG) reported its first quarter 2024 financial results and provided a business update and outlook for the remainder of 2024 (Press release, Galapagos, MAY 2, 2024, View Source [SID1234642637]).

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"We are moving forward with a renewed focus, a differentiated and expanding R&D pipeline, and competitive technology platforms to bring innovation to patients around the world. We continue to build a strong team of global leaders and we expanded our U.S. footprint," said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos. "As we look forward to the year ahead, we strive to make important progress in our clinical programs, achieving regulatory milestones to initiate clinical development of our CAR-T programs in the U.S., and expanding our decentralized CAR-T network in the U.S. and Europe. In parallel, we will continue to build our early-stage pipeline of cell therapy and small molecule investigational medicines in oncology and immunology, both internally and through external partnerships."

Thad Huston, CFO and COO of Galapagos, concluded: "We are committed to investing in our internal R&D pipeline, while we continue to actively pursue business development opportunities. We are broadening our oncology and immunology portfolio and will capitalize on opportunities that are aligned with our strategic objectives."

First quarter 2024 and recent business update

At the Annual and Extraordinary Shareholders’ Meetings held on 30 April 2024, all proposed resolutions were approved (see: press release of 30 April 2024).
Presented our innovative decentralized CAR-T manufacturing and 7-day vein-to-vein approach to hematological cancer care at the EBMT-EHA and EBMT annual meetings with new preliminary translational and previously published encouraging clinical data of our CD19 CAR-T candidates. The data support the promise of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (NHL) and GLPG5201 in relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT), in addressing the critical needs of patients facing poor prognosis.
Discontinued the development of CD19 CAR-T candidate in refractory systemic lupus erythematosus.
Transferred the Jyseleca business to Alfasigma per 31 January 2024.
Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen our growing early-stage oncology precision medicine pipeline.
Entered into a strategic collaboration agreement with Thermo Fisher Scientific for decentralized CAR-T manufacturing in the San Francisco area.
Participated with an investment of $40.0 million in the Series C financing round of precision oncology pioneer Frontier Medicines.
Financial performance
First quarter 2024 key figures (consolidated)
(€ millions, except basic & diluted income per share)

Three months ended 31 March % Change

2024 2023
Total net revenues 62.4 58.6 +7%
Cost of sales (2.5) –
R&D expenses (71.6) (52.5) +36%
G&Aii and S&Miii expenses (30.8) (27.1) +14%
Other operating income 9.4 6.8 +37%
Operating loss (33.1) (14.2)
Fair value adjustments and net exchange differences 30.6 (9.7)
Net other financial result 25.4 12.5
Income taxes 0.6 0.2
Net profit/loss (-) from continuing operations 23.5 (11.2)
Net profit from discontinued operations, net of tax 66.7 34.4
Net profit of the period 90.2 23.2
Basic and diluted earnings per share (€) 1.4 0.4
Current financial investments, cash & cash equivalents 3,557.9 4,005.5 (*)
(*) Including €15.4 million of net accrued interest income

DETAILS OF THE FINANCIAL RESULTS OF THE FIRST THREE MONTHS OF 2024
As a consequence of the transfer of our Jyseleca business to Alfasigma, the revenues and costs related to Jyseleca for the first quarter of 2024 are presented separately from the results of our continuing operations in the line ‘Net profit from discontinued operations, net of tax’ in our consolidated income statement. The comparative first quarter of 2023 has been restated accordingly for the presentation of the results related to the Jyseleca business.

Results from our continuing operations
Total operating loss from continuing operations for the three months ended 31 March 2024 was €33.1 million, compared to an operating loss of €14.2 million for the three months ended 31 March 2023.

Total net revenues for the three months ended 31 March 2024 amounted to €62.4 million, compared to €58.6 million for the three months ended 31 March 2023. The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €57.6 million for the first three months of both 2024 and 2023. Our deferred income balance at 31 March 2024 includes €1.2 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration.
Cost of sales for the three months ended 31 March 2024 amounted to €2.5 million and related to the supply of Jyseleca to Alfasigma under the transition agreement. The related revenues are booked in total net revenues.
R&D expenses in the first three months of 2024 amounted to €71.6 million, compared to €52.5 million for the first three months of 2023. This increase was primarily explained by higher costs for CAR-T and small molecule programs in oncology.
G&A and S&M expenses amounted to €30.8 million in the first three months of 2024, compared to €27.1 million in the first three months of 2023. This increase was primarily due to an increase in legal and professional fees, mainly related to business development activities.
Other operating income amounted to €9.4 million in the first three months of 2024, compared to €6.8 million for the same period last year. This increase is mainly due to €2.2 million of recharges for transition services to Alfasigma for the months of February and March 2024.
Net financial income in the first three months of 2024 amounted to €56.0 million, compared to net financial income of €2.8 million for the first three months of 2023.

Fair value adjustments and net currency exchange gains in the first three months of 2024 amounted to €30.6 million, compared to fair value adjustments and net currency exchange losses of €9.7 million for the first three months of 2023, and were primarily attributable to €12.4 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, and to €17.6 million of positive changes in fair value of current financial investments.
Net other financial income in the first three months of 2024 amounted to €25.4 million, compared to net other financial income of €12.5 million for the first three months of 2023, and was primarily attributable to €25.2 million of interest income, which increased significantly due to the increase in interest rates.
Net profit from continuing operations for the first three months of 2024 was €23.5 million, compared to a net loss from continuing operations of €11.2 million for the first three months of 2023.

Results from discontinued operations

(€ millions)

Three months ended 31 March % Change

2024 2023
Product net sales 11.3 26.7 -58%
Collaboration revenues 26.0 93.6 -72%
Total net revenues 37.3 120.3 -69%
Cost of sales (1.9) (3.6) -47%
R&D expenses (13.4) (51.0) -74%
G&A and S&M expenses (9.2) (31.1) -71%
Other operating income 53.9 1.5
Operating profit 66.7 36.1
Net financial result 0.1 (1.3)
Income taxes (0.1) (0.4)
Net profit from discontinued operations 66.7 34.4
Total operating profit from discontinued operations amounted to €66.7 million in the first three months of 2024, compared to an operating profit of €36.1 million in the same period last year.

Product net sales of Jyseleca in Europe were €11.3 million for the first three months of 2024 consisting of sales to customers in January 2024. Product net sales to customers for the first three months of 2023 amounted to €26.7 million. As from 1 February 2024, all economics linked to the sales of Jyseleca in Europe are to the benefit of Alfasigma.
Collaboration revenues for the development of filgotinib with Gilead amounted to €26.0 million for the first three months of 2024, compared to €93.6 million for the same period last year. The sale of the Jyseleca business to Alfasigma on 31 January 2024 led to the full recognition in revenue of the remaining deferred income related to filgotinib.
Cost of sales related to Jyseleca net sales were €1.9 million for the first three months of 2024. Cost of sales related to Jyseleca net sales for the first three months of 2023 amounted to €3.6 million.
R&D expenses for the development of filgotinib for the first three months of 2024 amounted to €13.4 million, compared to €51.0 million in the first three months of 2023. As from 1 February 2024, all filgotinib development expenses are recharged to Alfasigma.
G&A and S&M expenses related to the Jyseleca business amounted to €9.2 million in the first three months of 2024, compared to €31.1 million in the first three months of 2023. As from 1 February 2024, all remaining G&A and S&M expenses relating to Jyseleca are recharged to Alfasigma.
Other operating income for the first three months of 2024 amounted to €53.9 million (€1.5 million for the same period last year) and comprised €53.2 million related to the preliminary calculation of the gain on the sale of the Jyseleca business to Alfasigma. This preliminary result at 31 March 2024 of the transaction is considering the following elements:
€50.0 million of upfront payment received at closing of the transaction of which €40.0 million was paid on an escrow account. This amount will be kept in escrow for a period of one year after the closing date of 31 January 2024. We gave customary representations and warranties which are capped and limited in time (at 31 March 2024, this €40.0 million is presented as "Escrow account" in our balance sheet).
€13.2 million of cash received at closing of the transaction from Alfasigma for preliminary settlement for net cash and working capital and an additional adjustment estimated at €1.1 million related to settlement for completion accounts.
€47.0 million of estimated fair value on 31 January 2024 of the future earn-outs payable by Alfasigma to us (the fair value of these future earn-outs at 31 March 2024 is presented on the lines "Non-current contingent consideration receivable" and "Trade and other receivables").
€40.0 million of liability towards Alfasigma on 31 January 2024 for R&D cost contributions of which €5.0 million was paid in the first quarter of 2024 (at 31 March 2024, €35.0 million of liabilities for R&D cost contribution is presented in our balance sheet in "Other non-current liabilities" for €10.0 million and on the line "Trade and other liabilities" for €25.0 million).
Net profit from discontinued operations related to Jyseleca amounted to €66.7 million for the first three months of 2024, compared to a net profit amounting to €34.4 million for the first three months of 2023.

Cash, cash equivalents and current financial investments totaled €3,557.9 million as of 31 March 2024, as compared to €3,684.5 million as of 31 December 2023. Total net decrease in cash and cash equivalents and current financial investments amounted to €126.6 million during the first three months of 2024, compared to a net decrease of €88.6 million during the first three months of 2023. This net decrease was composed of (i) €125.2 million of operational cash burn, (ii) €36.9 million for the acquisition of financial assets held at fair value through profit or loss, (iii) €38.7 million of net cash in related to the sale of the Jyseleca business to Alfasigma of which €40.0 million has been transferred to an escrow account, offset by (iv) €36.8 million of positive exchange rate differences, positive changes in fair value of current financial investments and variation in accrued interest income.

Outlook 2024

Financial outlook
For the full year 2024, we reconfirm our cash burn guidance of €280 million to €320 million (compared to €414.8 million for the full year 2023), not including future potential business development opportunities.

R&D Outlook
We are progressing three CAR-T Phase 1/2 studies in hemato-oncology:
GLPG5101 in relapsed/refractory NHL;
GLPG5201 in relapsed/refractory CLL, and RT; and
GLPG5301 in relapsed/refractory multiple myeloma.
We are progressing two Phase 2 studies with TYK2 inhibitor GLPG3667, in systemic lupus erythematosus and in dermatomyositis.
We plan to file Investigational New Drug applications in the U.S. to progress clinical development of our CAR-T programs in hemato-oncology.
We will further upscale our CAR-T network and operations in the U.S. and Europe.
Business development
We will continue to evaluate business development opportunities that fit our strategy to accelerate and expand our pipeline of potential best-in-class investigational medicines in our therapeutic focus areas of oncology and immunology.

Conference call and webcast presentation
We will host a conference call and webcast presentation on 3 May 2024, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call by using the conference access information provided in the email received after registration, or by selecting the "call me" feature.

The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.

Entry into a Material Definitive Agreement

On May 2, 2024 Sonnet BioTherapeutics Holdings, Inc., a Delaware corporation (the "Company") entered into a ChEF Purchase Agreement (the "Purchase Agreement") and a Registration Rights Agreement (the "Registration Rights Agreement"), each with Chardan Capital Markets LLC ("Chardan") related to a "ChEF," Chardan’s committed equity facility (the "Facility") (Filing, 8-K, Sonnet BioTherapeutics, MAY 2, 2024, View Source [SID1234642635]). Pursuant to the Purchase Agreement, the Company has the right from time to time at its option to sell to Chardan up to the lesser of (i) $25,000,000 in aggregate gross purchase price of newly issued shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), and (ii) the Exchange Cap (as defined below), subject to certain conditions and limitations set forth in the Purchase Agreement. The Company is under no obligation to sell any securities to Chardan under the Purchase Agreement.

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While there are distinct differences, the Facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis outside the context of a traditional underwritten follow-on offering. From and after the Commencement (as defined below), sales of Common Stock to Chardan under the Purchase Agreement, and the timing of any sales, will be determined by the Company from time to time in its sole discretion and will depend on a variety of factors including, among other things, market conditions, the trading price of the Common Stock and determinations by the Company regarding the use of proceeds of such Common Stock. The net proceeds from any sales under the Purchase Agreement will depend on the frequency with, and prices at, which the shares of Common Stock are sold to Chardan. The Company expects to use the proceeds from any sales of shares of our Common Stock to Chardan under the Facility, together with our existing cash and cash equivalents, for research and development, including clinical trials, working capital and general corporate purposes.

Upon the satisfaction of the conditions to Chardan’s purchase obligation set forth in the Purchase Agreement (the "Commencement" and the date of initial satisfaction of all of such conditions, the "Commencement Date"), including that a registration statement registering the resale by Chardan of shares of Common Stock issued to it by the Company under the Purchase Agreement (the "Initial Resale Registration Statement") under the Securities Act of 1933, as amended (the "Securities Act"), which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC (the date of such effectiveness, the "Effective Date") and a final prospectus relating thereto is filed with the SEC, the Company will have the right, but not the obligation, from time to time at the Company’s sole discretion over the 36-month period from and after the Effective Date, to direct Chardan to purchase up to an amount of shares of Common Stock (the "VWAP Purchase Share Amount") not to exceed certain limitations set forth in the Purchase Agreement (each, a "VWAP Purchase") by delivering a written notice (a "VWAP Purchase Notice") to Chardan after 6:00 a.m., New York City time, but prior to 9:00 a.m., New York City time on any trading day (the "Purchase Date"), so long as all shares of Common Stock subject to all prior VWAP Purchases and Intraday VWAP Purchases (as defined below) theretofore required to have been received by Chardan have been received by Chardan in accordance with the Purchase Agreement and certain other conditions have been satisfied. The purchase price of the shares of Common Stock that the Company elects to sell to Chardan pursuant to the Purchase Agreement will be determined by reference to the volume weighted average price of the Common Stock ("VWAP") during the applicable Purchase Date on which the Company has timely delivered a VWAP Purchase Notice (and/or Intraday VWAP Purchase Notice (as defined below), as applicable), less a fixed 4.0% discount.

In addition to the regular VWAP Purchases described above, after the Commencement, the Company will also have the right, but not the obligation, subject to the continued satisfaction of the conditions set forth in the Purchase Agreement, from time to time at the Company’s sole discretion over the 36-month period from and after the Effective Date, to offer to Chardan the right to or, in certain circumstances, to direct Chardan, to purchase, on any trading day, including the same Purchase Date on which a regular VWAP Purchase is effected, up to an amount of shares of Common Stock (the "Intraday VWAP Purchase Share Amount") not to exceed certain limitations set forth in the Purchase Agreement that are similar to those that apply to a regular VWAP Purchase (each, an "Intraday VWAP Purchase"), by delivering a written notice (each, an "Intraday VWAP Purchase Notice") to Chardan prior to 3:00 p.m., New York City time, on such Purchase Date.

The Purchase Agreement provides that the number of shares of Common Stock issuable pursuant to any VWAP Purchase Notice (and, if applicable, the number of shares of Common Stock issuable pursuant to any Intraday VWAP Purchase Notice delivered on the same Purchase Date that such VWAP Purchase Notice is delivered) shall not, without Chardan’s express written agreement, exceed the lesser of: (i) the number of shares of Common Stock which, when aggregated with all other shares of Common Stock then beneficially owned by Chardan and its affiliates, would exceed the Beneficial Ownership Limitation (as defined below), (ii) the number of shares of Common Stock which would cause the total aggregate purchase price to be paid by Chardan in any VWAP Purchase together with, if applicable, all Intraday VWAP Purchases, made on one Purchase Date, to exceed $5.0 million, (iii) the number of shares of Common Stock that equals 20% of the total number (or volume) of shares of Common Stock traded on The Nasdaq Capital Market ("Nasdaq") (or a successor Principal Market (as defined in the Purchase Agreement)) during the applicable purchase period on such Purchase Date and (iv) the VWAP Purchase Share Amount (for a VWAP Purchase) or the Intraday VWAP Purchase Share Amount (for an Intraday VWAP Purchase).

Under the applicable rules and regulations of Nasdaq, in no event may the Company issue to Chardan under the Purchase Agreement more than 622,168 shares of Common Stock, which number of shares is equal to 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement (the "Exchange Cap"), unless the Company’s stockholders have approved the issuance of Common Stock pursuant to the Purchase Agreement in excess of the Exchange Cap in accordance with the applicable rules and regulations of Nasdaq or such approval is not required in accordance with the applicable rules and regulations of Nasdaq or otherwise. The Exchange Cap is not applicable to issuances and sales of Common Stock pursuant to VWAP Purchases and Intraday VWAP Purchases that the Company may effect pursuant to the Purchase Agreement to the extent such shares of Common Stock are sold in such VWAP Purchases or Intraday VWAP Purchases (as applicable) at a weighted average price (when taking into account prior purchases under the Facility) equal to or in excess of the applicable "minimum price" (as defined Nasdaq Listing Rule 5635(d)) of the Common Stock, calculated at the time such VWAP Purchases or Intraday VWAP Purchases (as applicable) are effected by the Company under the Purchase Agreement, if any, as adjusted as necessary for compliance with the rules of Nasdaq to take into account certain fees and expenses payable and/or reimbursable by the Company to Chardan. Moreover, the Company may not issue or sell any shares of Common Stock to Chardan under the Purchase Agreement which, when aggregated with all other shares of Common Stock then beneficially owned by Chardan and its affiliates (as calculated pursuant to Section 13(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 13d-3 promulgated thereunder), would result in Chardan beneficially owning more than 4.99% of the outstanding shares of Common Stock (the "Beneficial Ownership Limitation").

There are no restrictions on future financings, and no rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, as applicable, other than a prohibition on entering (with certain limited exceptions) into a Specified Transaction (as defined in the Purchase Agreement), as further described in the Purchase Agreement. At no time prior to the date of the Purchase Agreement has Chardan engaged in or effected, in any manner whatsoever, directly or indirectly for its own principal account, any (i) "short sale" (as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of the Common Stock or (ii) hedging transaction, which establishes a net short position with respect to the Common Stock that remains in effect as of the date of the Purchase Agreement.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

The Purchase Agreement will automatically terminate on the earliest to occur of (i) the 36-month anniversary of the Effective Date of the Initial Resale Registration Statement (such term being subject to extension by the parties to the Purchase Agreement), (ii) the date on which Chardan shall have purchased $25,000,000 of shares of Common Stock pursuant to the Purchase Agreement, (iii) the date on which the Common Stock shall have failed to be listed or quoted on Nasdaq or a successor Principal Market, and (iv) the commencement of certain bankruptcy proceedings or similar transactions with respect to the Company or all or substantially all of its property.

The Company has the right to terminate the Purchase Agreement at any time after Commencement, at no cost or penalty, upon ten (10) trading days’ prior written notice to Chardan. Chardan also has the right to terminate the Purchase Agreement upon ten (10) trading days’ prior written notice to us, but only upon the occurrence of certain customary events as listed in the Purchase Agreement. Neither the Company nor Chardan may assign or transfer its rights and obligations under the Purchase Agreement or the Registration Rights Agreement.

As consideration for Chardan’s commitment to purchase shares of Common Stock at the Company’s direction upon the terms and subject to the conditions set forth in the Purchase Agreement, (i) on the Effective Date, the Company shall pay to Chardan a non-refundable commitment fee of $100,000 (the "Initial Commitment Fee"), and (ii) prior to or on the 6-moth anniversary of the Purchase Agreement, the Company shall pay to Chardan a non-refundable commitment fee of $150,000. The Company also paid Chardan a documentation fee, consisting of $25,000 in connection with the preparation of the Purchase Agreement. Further, the Company agreed to reimburse Chardan for its fees and expenses (including fees and disbursements of its counsel) (i) for initial diligence and documentation related to the Facility in an amount up to $75,000, provided, however, that any amount of reimbursement exceeding $75,000 will reduce, on a dollar-for-dollar basis, the Initial Commitment Fee, and (ii) up to $20,000 per fiscal quarter during which the Facility is active and not suspended for its reasonable and documented fees and expenses related to ongoing diligence of the Company except for any quarter in which additional diligence is reasonably required because of a material amendment or restatement to the registration statement, in which such amount shall not exceed $25,000 per quarter, absent unusual circumstances, provided, that such amount is not to exceed $300,000 in the aggregate during the term of the Purchase Agreement

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to, and incorporate herein by reference, the full text of the Purchase Agreement and the Registration Rights Agreement, which are filed herewith as Exhibit 10.1 and Exhibit 10.2, respectively.

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