Entry Into a Material Definitive Agreement

On February 18, 2025 Plus Therapeutics, Inc. (the "Company") reported the company entered into a Securities Purchase and Exchange Agreement (the "SPEA") with certain existing accredited investors (the "Purchasers") (Filing, Cytori Therapeutics, FEB 18, 2025, View Source [SID1234650333]). Pursuant to the SPEA, on the Closing Date the Company issued secured convertible promissory notes (the "Funding Notes") in the aggregate principal amount of $3,362,251 together with common stock purchase warrants (the "Warrants") to purchase 3,002,009 shares of the Company common stock, par value $0.001 (the "Common Stock") at an exercise price of $1.12 per share (the "Warrant Exercise Price"). The aggregate purchase price for the Funding Note and Warrants was approximately $3.7 million (the "Aggregate Purchase Price") and included payment of $0.125 per Warrant in accordance with the Nasdaq Listing Rules.

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The Funding Notes mature on February 13, 2026, and bear interest at a rate of 10% per annum, subject to increase upon Events of Default.

The Warrants are exercisable for five-years from the date of issuance.

Secured Interest

The obligations of the Company under the SPEA and the Notes (as defined below) are secured by a pledge of substantially all of assets of the Company pursuant to a security agreement, dated as of the Closing Date, among the Company, CNSide Diagnostics, LLC (a subsidiary of the Company, "CNSide"), and Iroquois Master Fund Ltd., as collateral agent for the Purchasers (the "Security Agreement), subject to certain exceptions. The Security Agreement contains certain customary affirmative and negative covenants, including limitations on the Company’s and CNSide’s ability to dispose of assets, subject to customary exceptions. The repayment of the Company’s obligations under the SPEA and Notes are guaranteed pursuant to a subsidiary guarantee, dated as of the Closing Date (the "Subsidiary Guarantee"), by and among CNSide and the Purchasers.

Mandatory Conversion

In the event of a Common Stock financing by the Company on or before March 31, 2025, in which the Company receives at least $10.0 million in gross proceeds and that meets certain other conditions specified in the SPEA (a "Qualified Financing"), at the election of the Company seventy-five percent of the principal amount and interest of the Funding Notes, or at the election of the Purchaser, all of the principal amount and interest of the Funding Notes, will convert into the securities issued in the Qualified Financing (the "Mandatory Conversion"). The Mandatory Conversion does not apply, however, in the event that per share of Common Stock price in the Qualified Financing is $2.00 or greater (the "Maximum Amount").

Upon a consummation of a Qualified Financing, any portion of the Funding Notes not mandatorily converted in the Qualified Financing by the Company, at each Purchaser’s option, will either be voluntarily converted into such securities issued in the Qualified Financing or redeemed in cash.

Voluntary Conversion

Each Funding Note is convertible at any time after the Closing Date, at the option of each Purchaser, subject to certain exceptions set forth in the Funding Notes, into shares of Common Stock, or to comply with certain beneficial ownership limitations, into pre-funded warrants (the "Pre-Funded Warrants"), exercisable immediately at an exercise price of $0.001 per share. The initial conversion price for the Funding Notes is $1.12 per share (the "Conversion Price").

Anti-Dilution

Subject to obtaining stockholder approval, the Conversion Price and the Warrant Exercise Price are subject to anti-dilution protection upon any subsequent transaction at a fixed price lower than the Conversion Price or Warrant Exercise Price, as applicable, then in effect and standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction.

Covenants

The Funding Notes provide for certain customary negative covenants regarding the incurrence of certain indebtedness, the creation of liens, the repayment of indebtedness, the payment of cash or assets in respect of dividends, distributions or redemptions, and the transfer of assets, among other matters.

Company Optional Redemption Rights

Subject to Equity Conditions (as such term is defined in the Funding Notes), each Funding Note may be prepaid, at the option of the Company, in whole or in part, by paying in cash to the Purchaser the Mandatory Default Amount (as such term is defined in the Funding Notes) or 120% of the principal amount of the Funding Note, together with any accrued and unpaid interest and unpaid late charges thereon. In addition, the Company may prepay each Funding Note upon a Fundamental Transaction (as such term is defined in the Funding Notes) or a Change of Control Transaction (as such term is defined in the Funding Notes), provided that shares of Common Stock issuable pursuant to the Funding Notes are then registered under an effective registration statement, by paying to the Purchasers the Mandatory Default Amount.

Terms of the SPEA

The SPEA contains certain representations and warranties, covenants and indemnities customary for similar transactions.

Under the SPEA, the Company agreed, among other conditions, to not effect or enter an agreement to effect any variable rate transaction, except for certain exempt issuances of equity securities, until the later of the two year anniversary of the Closing Date or such date that the Notes are no longer outstanding. The Company also agreed to hold a stockholder meeting by no later than May 30, 2025, to seek approvals for future adjustments of the Warrant Exercise Price and Conversion Price for anti-dilution adjustments and similar matters, the reduction of the exercise price of the Warrants by $0.125, the extension of the period of exercise for the Series B common warrants issued pursuant to the May 2024 Purchase Agreement until five years from the original issue date of those warrants, and other matters necessary for compliance with Nasdaq Listing Rule 5635(d) (the "Stockholder Approvals"). Pursuant to the SPEA, the Company will be obligated to continue to seek the Stockholder Approvals at least three times each year until the Stockholder Approvals are obtained.

In addition, the Company granted the Purchasers participation rights in future offerings of Common Stock or Common Stock Equivalents (as such term is defined in the SPEA) for cash consideration, during the later of 18 months after the Closing Date or such time as less than 50% of the Warrants remain outstanding, in an amount of up to 50% of the securities being sold in such offerings.

Exchange Notes

As previously disclosed, the Company entered into that certain securities purchase agreement, dated May 5, 2024, as amended on May 8, 2024 (the "May 2024 Purchase Agreement"), with the Purchasers, among other investors, for the private placement of securities, including Series A common warrants ("Series A Warrants") to purchase an aggregate of up to 3,591,532 shares of common stock. The May 2024 Purchase Agreement included certain limitations and restrictions on the Company’s ability to issue securities and provided the Purchasers and the other investors signatories to the May 2024 Purchase Agreement participation rights in future equity and equity-linked offerings of securities, subject to certain limited exceptions (the "Financing Restrictions"). On the Closing Date, pursuant to the SPEA, the Company issued to the Purchases secured convertible promissory notes in the aggregate amount of $3,188,922 (the "Exchange Notes" and together with the Funding Notes, the "Notes") in exchange for cancellation of the Series A Warrants of the Purchasers, and the Purchasers entered into a second amendment to the May 2024 Purchase Agreement to eliminate the Financing Restrictions (the "Financing Waiver").

The terms and conditions of the Exchange Notes are substantially identical in all material respects to the Funding Notes, except that the Mandatory Conversion applies to all of the principal amount of the Exchange Notes instead of being limited to seventy-five percent, and the Maximum Amount does not apply. The Security Agreement and Subsidiary Guarantee also apply to the obligations under the Exchange Notes.

Registration Rights Agreement

In connection with the SPEA, the Company entered into a registration rights agreement (the "Registration Rights Agreement"), dated as of the Closing Date, with the Purchasers, pursuant to which the Company agreed to prepare and file a registration statement with the Securities and Exchange Commission (the "Commission") covering the resale of the shares of Common Stock issuable pursuant to the Notes and Warrants (the "Registration Statement") at the earlier of the fifteenth calendar day after the Company has filed its Annual Report on Form 10-K for the calendar year ended December 31, 2024, or April 15, 2025 (the "Filing Due Date"), and to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than June 30, 2025 (the "Effectiveness Due Date"), provided, however, that the Effectiveness Due Date for the shares of common stock issuable under the Exchange Notes is the earlier of the fifteenth calendar day after the Company has filed its Annual Report on Form 10-K for the calendar year ended December 31, 2024, or April 15, 2025. In addition, pursuant to the Registration Rights Agreement, the Company is required to use its reasonable best efforts to keep the Registration Statement continuously effective from the date on which the Commission declares the Registration Statement to be effective until such date that all Registrable Securities (as such term is defined in the Registration Rights Agreement) covered by the Registration Statement have been sold pursuant to a registration statement under the Securities Act of 1933, as amended (the "Securities Act"), under Rule 144 as promulgated by the Commission under the Securities Act ("Rule 144"), or otherwise shall have ceased to be Registrable Securities.

In the event that (i) the Company fails to file the Registration Statement by the Filing Due Date, (ii) the Company fails to file with the Commission a request for acceleration of the Registration Statement within 5 Trading Days (as such term is defined in the Registration Rights Agreement) of the date that the Company is notified by the Commission that such Registration Statement will not be "reviewed" or will not be subject to further review, (iii) the Registration Statement is not declared effective on or prior to the Effectiveness Due Date, (iv) after being declared effective, (A) the Registration Statement ceases to remain continuously effective as to all Registrable Securities for which it is required to be effective, or (B) the holders are not permitted to utilize the prospectus in the Registration Statement to sell Registrable Securities, other than certain allowed delays, or (v) an allowed delay exceeds beyond the length permitted for an allowed delay, then the Company has agreed (unless the Registrable Securities are freely tradable pursuant to Rule 144) to make payments to each Purchaser as liquidated damages in an amount equal to 1% of the aggregate amount invested by each such holder in the Registrable Securities, subject to a 12% cap in the aggregate as set forth in the Registration Rights Agreement.

The Company has granted the Purchasers customary indemnification rights in connection with the Registration Rights Agreement. The Purchasers have also granted the Company customary indemnification rights in connection with the Registration Rights Agreement.

The foregoing descriptions of the SPEA, Funding Notes, Exchange Notes, Security Agreement, Subsidiary Guarantee, Warrants, Pre-Funded Warrants, Financing Waiver, and Registration Rights Agreement are qualified in their entirety by reference to the full text of such documents, copies of which are attached hereto as exhibits, and each of which is incorporated herein in its entirety by reference. 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.

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

The information set forth in Item 1.01 above relating to the SPEA and Notes is incorporated herein by reference.

Item 3.02 Unregistered Sales of Equity Securities.

The information set forth in Item 1.01 of this Current Report on Form 8-K regarding the sale and issuance of the securities is incorporated herein by reference into this Item 3.02.

The Company issued the Exchange Notes in reliance on the exemption from registration afforded by Section 3(a)(9) of the Securities Act, The Company otherwise sold the securities to "accredited investors," as that term is defined in the Securities Act, in reliance on the exemption from registration afforded by Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder, and corresponding provisions of state securities or "blue sky" laws. The Purchasers represented that they were acquiring the securities pursuant to the SPEA for investment only and not with a view towards the resale or distribution thereof in violation of the Securities Act. Accordingly, the securities issued pursuant to the SPEA have not been registered under the Securities Act and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.

Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein.

Item 7.01 Regulation FD Disclosure.

On February 18, 2025, the Company issued a press release announcing the private placement and exchange described above and a $2.0 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT), as part of its existing $17.6 million grant.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number
Description of Document

4.1 Form of Pre-Funded Warrant
4.2 Form of Warrant issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.1* Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.2 Form of Secured Convertible Note for Funding Notes issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.3 Form of Secured Convertible Note for Exchange Notes issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.4* Security Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc., CNSide Diagnostics, LLC, and Iroquois Master Fund Ltd., as collateral agent for the purchasers named therein
10.5 Subsidiary Guarantee, dated as of February 13, 2025, by and among CNSide Diagnostics, LLC and the purchasers named therein
10.6 Registration Rights Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein
10.7 Second Amendment to Securities Purchase Agreement, dated May 5, 2024, as amended on May 9, 2024, by and among Plus Therapeutics, Inc. and the purchasers named therein
104 Cover Page Interactive Data File (embedded with the Inline XBRL document)

*
Schedules and exhibits have been Omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish supplemental copies of any of the Omitted schedules or exhibits upon request by the Securities and Exchange Commission; provided that the Company may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, for any schedules or exhibits so furnished.

Cidara Therapeutics Announces Appointment of Frank Karbe as Chief Financial Officer

On February 18, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, reported that Frank Karbe has been appointed Chief Financial Officer (CFO), effective February 24, 2025 (Press release, Cidara Therapeutics, FEB 18, 2025, View Source [SID1234650332]). Mr. Karbe will succeed Preetam Shah, Ph.D., MBA, who is departing to pursue other professional opportunities. Dr. Shah will serve as a consultant to the Company.

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"We are pleased to welcome Frank to the team as we advance our long-acting influenza antiviral drug CD388 through the end of this flu season in the Phase 2b NAVIGATE study and plan for Phase 3 and beyond." said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "We expect that Frank’s extensive experience as a leader in the biopharma industry and proven track record for transitioning companies to multi-billion-dollar commercial organizations will prove invaluable to the strategic vision of Cidara. On behalf of the entire Cidara team, I thank Preetam for his guidance and dedication which helped position Cidara for success. We wish him luck in his future endeavors."

Mr. Karbe added, "Cidara is at an important stage in the company’s evolution, with its novel DFC candidate, CD388, showing immense potential as a universal influenza preventative. Influenza continues to drive significant morbidity and mortality despite the availability of vaccines and antiviral treatments. I am excited to join the Cidara team and look forward to leveraging my experience to drive the company’s growth and bring CD388 to the tens of millions of patients who can benefit from it."

Mr. Karbe is a widely experienced senior executive with over 25 years of leadership experience in life sciences, healthcare, and technology. Most recently, he served as Chief Executive Officer and President of Better Therapeutics, where he led the company to the first-ever FDA authorization of a digital therapeutic for the treatment of type 2 diabetes. Previously, as President and Chief Financial Officer of Myovant Sciences, Mr. Karbe played a pivotal role in scaling the company from a startup to a publicly listed company with 500+ employees and two FDA approved products in under five years, raising over $2 billion in capital and securing a $4 billion partnership with Pfizer. He also served for over a decade as Executive Vice President and Chief Financial Officer at Exelixis, where he drove the company’s transformation from discovery to commercialization. Earlier in his career, he worked as an investment banker for Goldman Sachs, focusing on corporate finance and mergers & acquisitions in the life sciences industry.

Celyad Oncology announces the publication of the preclinical and clinical data of CYAD-211 providing proof-of-concept of its miRNA-based shRNA platform

On February 18, 2025 Celyad Oncology (Euronext: CYAD) (the "Company"), reported the publication of the preclinical data of the non-gene edited allogeneic CYAD-211 and clinical data from the Phase I IMMUNICY-1 clinical study which evaluated CYAD-211 in relapsed or refractory (r/r) multiple myeloma (MM) patients (Press release, Celyad, FEB 18, 2025, View Source [SID1234650331]). The findings were published in the International Journal of Molecular Science (IJMS).

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CYAD-211 is the Company’s first allogeneic chimeric antigen receptor (CAR) T-cell candidate, engineered to co-express a B-cell maturation antigen (BCMA)-specific CAR and a microRNA-based single shRNA which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex, evaluated clinically.

The IJMS publication includes preclinical data which showcases the knockdown of CD3ζ efficiently removed the TCR complex from the cell surface, and inhibited TCR mediated activation in vitro and in vivo. The publication also presents clinical data of the dose-escalation segment of the IMMUNICY-1 phase-I clinical trial (NCT04613557) in patients with r/r MM. Importantly, data highlighted an overall good safety profile and some clinical responses, with no signs of graft-versus-host disease (GvHD), demonstrating the effectiveness and safeness of the technology to abrogate the risk of GvHD.

Overall, these data provides the proof-of-concept of the safe administration of CAR T-cells engineered using a miRNA-based shRNA technology. CYAD-211 is the first allogeneic CAR T-cell candidate using a non-gene edited approach to achieve allogenicity. This differentiated strategy provides key advantages by being easily implemented, safe, efficient, tunable, and with the possibility to modulate multiple target genes simultaneously.

Results of Operations and Financial Condition

On February 18, 2025, Arcus Biosciences, Inc. (the "Company") reported that, as of December 31, 2024, it had approximately $992 million in cash, cash equivalents and marketable securities (Press release, Arcus Biosciences, FEB 18, 2025, View Source [SID1234650330]). This estimate of its cash, cash equivalents and marketable securities balance is preliminary and subject to completion of its financial closing procedures, including the completion of management’s reviews. Accordingly, the unaudited preliminary cash, cash equivalents and marketable securities balance set forth above reflects its preliminary estimate with respect to such information, based on information currently available to management, and may vary from its actual financial position as of December 31, 2024. Further, this preliminary estimate is not a comprehensive statement or estimate of its financial results or financial condition as of December 31, 2024.

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Item 8.01 Other Events.

The contents of Item 2.02 above are also incorporated by reference into this Item 8.01.

Gilead Opt-in Decision

On February 18, 2025, the Company announced that the time-limited exclusive option of Gilead Sciences, Inc. ("Gilead") to the casdatifan program has expired without exercise by Gilead. As a result, Gilead has no future rights to casdatifan; the Company retains full global development and commercial rights, subject to Taiho Pharmaceutical Co., Ltd.’s option right for its territory, which is limited to Japan and certain other Asian countries (excluding China).

ARC-20 Data Release

On February 15, 2025, the Company reported new data from three cohorts of its ARC-20 study for casdatifan in patients with metastatic clear cell renal cell carcinoma, most of whom had progressed on at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor therapy. The new data include median progression-free survival and overall response rate ("ORR") for the cohort evaluating 50mg of casdatifan twice a day ("BID"), and ORR for the cohorts evaluating 50mg of casdatifan once daily ("QD") and 100mg QD. The patient population was heavily pretreated; more than half (52-59%) of subjects received at least three prior lines of therapy and approximately one quarter (24-29%) had received at least four prior lines of therapy. Most patients (70-76%) had an International Metastatic Renal Cell Carcinoma Database Consortium risk factor of intermediate or poor.

With a data cut-off of January 3, 2025 (the "DCO"), most patients (81-87%) experienced disease control with either a partial response or stable disease. The median duration of response had not been reached, with all but two of the 26 responders across all three cohorts still on treatment.

No unexpected safety signals were observed at the time of the DCO, and casdatifan had an acceptable and manageable safety profile across all doses. Across all three cohorts, one patient discontinued treatment as a result of anemia and two due to hypoxia. A summary of the efficacy and safety results is below:

50mg BID
(n=32) 50mg QD
(n=28) 100mg QD Tablet
(Go-forward dose)
(n=27)
Efficacya

Median Follow-up 15 months 12 months 5 monthsb
Median Progression-Free

Survival [95% CI]

9.7 months
(5.5, NE)

NE
(6.8, NE)

NE
Confirmed ORR per

RECIST v1.1 [95% CI]

25% (8)c
[11.5, 43.4]

32% (9)c
[15.9, 52.4]

33% (9)
[16.5, 54.0]

Best Overall Responsed:

Complete Response

Partial Response

Stable Disease

Progressive Disease

31% (10)
0

31% (10)

50% (16)

19% (6)

32% (9)
4% (1)

29% (8)

54% (15)

14% (4)

33% (9)
0

33% (9)

52% (14)

15% (4)e

Median Time to Response 2.8 months 4.1 months 1.6 months
Disease Control Rate

[95% CI]

81%
[63.6, 92.8]

86%
[67.3, 96.0]

85%
[66.3, 95.8]

Safetyf

Any Serious Treatment-Emergent

Adverse Events (TEAEs)

related to casdatifan

3% (1) 10% (3) 7% (2)
Grade ≥3 TEAEs related to

casdatifan

Anemia

Hypoxia

42% (14)
9% (3)

32% (10)
7% (2)

17% (5)
10% (3)

CI=confidence interval, NE=not estimable

a Efficacy-evaluable population for this expansion cohort is defined as all eligible participants who received any study treatment and have at least one post-baseline efficacy assessment, or who discontinue study treatment due to progressive disease or death.

b Majority of patients (n=21) were still on treatment at time of DCO.

c In the 50mg BID cohort, one unconfirmed responder remains on treatment. In the 50mg QD cohort, one unconfirmed responder became a confirmed responder after the DCO, increasing the cORR to 32%.

d Unconfirmed best overall response.

e Includes two patients with radiological progressive disease and two patients who had clinical progression before the first scan.

f The safety-evaluable population included all dose expansion enrolled patients who received any amount of any study treatment.

Anixa Biosciences Announces Approval of Protocol Amendment for Ovarian Cancer CAR-T Clinical Trial

On February 18, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer reported that it, along with its partner Moffitt Cancer Center ("Moffitt"), has received approval for an amendment to the protocol governing its ongoing clinical trial using CAR-T therapy for the treatment of ovarian cancer (NCT05316129) (Press release, Anixa Biosciences, FEB 18, 2025, https://ir.anixa.com/news/detail/1066/anixa-biosciences-announces-approval-of-protocol-amendment-for-ovarian-cancer-car-t-clinical-trial [SID1234650329]).

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The key changes in the protocol allows patients who may benefit from a second dose of the CAR-T therapy to receive it and expands enrollment eligibility to include patients with sex cord-stromal tumors (SCSTs) and Sertoli Leydig cell tumors (SLCTs). Previously, Anixa and Moffitt had secured a single patient IND approval for an additional dose for a patient whose biopsy showed cellular infiltration and necrosis, indicating biological activity of the CAR-T therapy. With this amendment, all eligible patients in the trial can receive a second dose of the CAR-T therapy without the need to submit individual INDs for each case.

Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt and the principal investigator of the trial, stated, "This amendment is a crucial development in our ongoing efforts to advance the treatment of ovarian cancer with CAR-T therapy. The ability to administer a second dose to patients who show potential for additional benefit provides us with more flexibility and an opportunity to further evaluate the effectiveness of this innovative therapy."

"We are excited about the approval of this protocol amendment, as it allows us to potentially enhance the efficacy of our CAR-T therapy by providing a second dose to patients who might benefit from it and to treat additional rare types of ovarian cancer. This is a significant step in optimizing the treatment for ovarian cancer, and we look forward to continuing our work with Moffitt Cancer Center as we strive to improve outcomes for patients facing this difficult disease," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.