On May 11, 2023 PharmaCyte Biotech, Inc. (Nasdaq: PMCB) ("PharmaCyte" or the "Company") reported a cash tender offer for up to 7,750,000 shares at $3.25 per share, less any applicable withholding taxes and without interest (Press release, PharmaCyte Biotech, MAY 11, 2023, View Source [SID1234631529]). The Company also announces that it has completed a private placement financing of convertible redeemable preferred stock and warrants from existing investors, raising gross proceeds of approximately $35 million in a private placement financing of convertible redeemable preferred stock and warrants from existing investors.

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Tender Offer

The Company intends to commence the tender offer today, May 11, 2023. The tender offer is scheduled to expire at 11:59 p.m., New York City time, on June 9, 2023, unless extended or earlier terminated (the "expiration date"). The purchase of common stock in connection with the tender offer will be funded entirely through the Company’s cash on hand.

Stockholders must validly tender and not validly withdraw their common stock before the expiration date to be eligible to participate in the tender offer. Tendered shares of common stock may only be withdrawn on or before the expiration date.

The tender offer will be subject to various terms and conditions as will be described in the Offer to Purchase. The Depositary for the tender offer will be American Stock Transfer & Trust Company, LLC, and the Information Agent for the tender offer will be D.F. King & Co., Inc.

None of the Company or its Board of Directors, the Information Agent for the tender offer, or the Depositary for the tender offer will make any recommendation to shareholders as to whether to tender or refrain from tendering their shares in the tender offer. Shareholders must make their own decision as to how many shares they will tender, if any. Shareholders should consult their financial and tax advisors in making this decision.

PharmaCyte’s CEO Josh Silverman commented, "We continue to evaluate our current assets, which are intended to address a highly unmet medical need in pancreatic cancer. However, given that we are unable at this time to provide shareholders with a definitive timeframe on when we expect to have completed that evaluation or to predict what steps we will take following our evaluation, we believe it is in the best interest of both the Company and its shareholders to provide the opportunity for existing, and in some cases long-time, shareholders to move on, while still allowing those dedicated to the Company to remain for what may be a very long process until regulatory approval of any commercial asset. Based on our current cash position, in-house assets, and a simultaneous search for additional assets that we believe would be accretive to the Company, we believe our current strategy and activities have the highest potential to maximize shareholder value. Our financing helps to maintain our very favorable cash position, and we are grateful to all of our shareholders, regardless of their actions around this tender offer, for their loyalty and patience in this continued time of transition for the Company. We look forward to the time when we are able to provide more specific updates regarding Cell-in-a-Box or a potential strategic acquisition."

The tender offer described in this press release has not yet commenced. This press release is for information purposes only, and is not an offer to purchase or the solicitation of an offer to sell any shares of PharmaCyte common stock. The solicitation of offers to purchase shares of PharmaCyte common stock will be made only pursuant to the tender offer documents, including an Offer to Purchase and related Letter of Transmittal, that the Company intends to distribute to shareholders and file as part of a tender offer statement on Schedule TO with the U.S. Securities and Exchange Commission (the "SEC"), today, May 11, 2023.

PHARMACYTE SHAREHOLDERS ARE URGED TO READ THE TENDER OFFER STATEMENT (INCLUDING THE OFFER TO PURCHASE, LETTER OF TRANSMITTAL AND RELATED TENDER OFFER DOCUMENTS) WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY PHARMACYTE WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION CONCERNING THE TERMS OF THE TENDER OFFER.

Once the tender offer is commenced, copies of the tender offer statement on Schedule TO, the Offer to Purchase, the Letter of Transmittal and other documents that the Company will be filed with the SEC, will be distributed by the Company to the Company’s shareholders at no expense to them and will also be available to shareholders free of charge at the SEC website at www.sec.gov.

Private Placement

The Company has completed a private placement financing of convertible redeemable preferred stock and warrants from existing investors, raising gross proceeds of approximately $35 million. The preferred stock has a conversion price of $4.00 per share, subject to adjustment, and warrants to acquire up to an aggregate amount of 8,750,000 additional shares of the Company’s common stock. The warrants are exercisable immediately at an exercise price of $4.00 per share and expire five years from the date of issuance. The preferred stock conversion price and warrant exercise price of $4.00 per share represent an approximately 43.9% premium to yesterday’s closing share price.

The preferred stock, along with the associated warrants, were offered and sold in a transaction exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws. Accordingly, the preferred stock, warrants and underlying shares of common stock issuable upon conversion or exercise of the preferred stock and warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issuable upon conversion of the preferred stock and exercise of the warrants issued in connection with the private placement.

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

On May 11, 2023 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported plans to share preliminary data from the dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial for NVL-655, a novel ALK-selective inhibitor, in the second half of 2023, and reported first quarter 2023 financial results (Press release, Nuvalent, MAY 11, 2023, View Source [SID1234631528]).

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ALKOVE-1 is a Phase 1/2, multicenter, open-label, dose-escalation and expansion trial evaluating NVL-655 in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. The Phase 1 dose-escalation portion of the study is enrolling patients with previously treated ALK-positive solid tumors and will evaluate the overall safety and tolerability of NVL-655. Additional objectives include determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. Preclinical data, including those presented recently at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, demonstrated that NVL-655 had broad preclinical activity across diverse ALK oncoproteins, single and compound resistance mutations, and tumor types while maintaining strong selectivity for ALK over TRKB and CNS penetrance.

"2023 is a year of focused, data-driven execution towards our goal of delivering a pipeline of novel kinase inhibitors to patients as efficiently as possible," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We plan to report preliminary data from our ALKOVE-1 trial of NVL-655 for patients with advanced ALK-positive NSCLC and other solid tumors in the second half of the year. We continue to enroll patients in the Phase 1 portion of the ARROS-1 trial of NVL-520 for advanced ROS1-positive NSCLC and other solid tumors in support of RP2D selection, and to advance NVL-330, our novel HER2-selective inhibitor for patients with HER2 exon 20 insertion-positive cancers, through IND-enabling studies. With a solid cash position and an expert team, we are well-positioned to deliver on both our near- and long-term goals."

First Quarter 2023 Financial Results

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Cash Position & Operating Runway: Cash, cash equivalents and marketable securities were $450.5 million as of March 31, 2023. Nuvalent believes the existing cash, cash equivalents and marketable securities are expected to be sufficient to fund its current operating plan into the second half of 2025.
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R&D Expenses: Research and development (R&D) expenses were $22.1 million for the first quarter of 2023.
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G&A Expenses: General and administrative (G&A) expenses were $8.1 million for the first quarter of 2023.
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Net Loss: Net loss for the first quarter of 2023 was $25.2 million, or $0.44 per share.
About NVL-655

NVL-655 is a novel brain-penetrant ALK-selective inhibitor created to overcome limitations observed with currently available ALK inhibitors. NVL-655 is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with the solvent front G1202R mutation or compound mutations G1202R / L1196M ("GRLM"), G1202R / G1269A ("GRGA"), or G1202R/L1198F ("GRLF"). NVL-655 has been optimized for CNS penetrance to improve treatment options for patients with brain metastases. NVL-655 has been observed in preclinical studies to selectively inhibit wild-type ALK and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and drive more durable responses for patients. NVL-655 is currently being investigated in the ALKOVE-1 study (NCT05384626), a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive NSCLC and other solid tumors.

On May 11, 2023 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported that it will present preliminary data from its Phase 1 dose escalation clinical trial of NKX019 at two upcoming scientific conferences in June 2023: the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Hybrid Congress and the 17TH International Conference on Malignant Lymphoma (17-ICML) (Press release, Nkarta, MAY 11, 2023, View Source [SID1234631527]). NKX019 is an allogeneic, off-the-shelf cell therapy candidate comprising NK cells derived from healthy donors and engineered to target the B-cell antigen CD19.

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The purpose of the presentations is to ensure that clinical investigators and the broader clinical community have the opportunity to assess the NKX019 clinical data from the November 2022 data cut-off in a peer-reviewed format. These data were previously disclosed at a company event in December 2022. Nkarta continues to plan to present an update to these data later in 2023.

European Hematology Association 2023 Hybrid Congress
Oral Presentation: First in Human Data of NKX019, an Allogeneic CAR NK for the Treatment of Relapsed/Refractory (R/R) B-Cell Malignancies
June 10, 2023
Session s437 4:30 p.m. – 5:45 p.m. CEST
Presentation S261
Abstracts are available on the EHA (Free EHA Whitepaper) website.

17TH International Conference on Malignant Lymphoma
Encore Poster Presentation: First in Human Data of NKX019, an Allogeneic CAR NK for the Treatment of Relapsed/Refractory (R/R) B-Cell Malignancies
June 14 – June 16, 2023
Abstract 389
Abstract titles are available on the 17-ICML website.
Abstracts are expected to be available on the ICML website on June 9, 2023 at 5:59 p.m. ET.

The presentations will be made available electronically on the Nkarta website following their delivery at the scheduled scientific sessions.

About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.

On May 11, 2023 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported that it will present preliminary data from its Phase 1 dose escalation clinical trial of NKX019 at two upcoming scientific conferences in June 2023: the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Hybrid Congress and the 17TH International Conference on Malignant Lymphoma (17-ICML) (Press release, Nkarta, MAY 11, 2023, View Source [SID1234631526]). NKX019 is an allogeneic, off-the-shelf cell therapy candidate comprising NK cells derived from healthy donors and engineered to target the B-cell antigen CD19.

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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

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The purpose of the presentations is to ensure that clinical investigators and the broader clinical community have the opportunity to assess the NKX019 clinical data from the November 2022 data cut-off in a peer-reviewed format. These data were previously disclosed at a company event in December 2022. Nkarta continues to plan to present an update to these data later in 2023.

European Hematology Association 2023 Hybrid Congress
Oral Presentation: First in Human Data of NKX019, an Allogeneic CAR NK for the Treatment of Relapsed/Refractory (R/R) B-Cell Malignancies
June 10, 2023
Session s437 4:30 p.m. – 5:45 p.m. CEST
Presentation S261
Abstracts are available on the EHA (Free EHA Whitepaper) website.

17TH International Conference on Malignant Lymphoma
Encore Poster Presentation: First in Human Data of NKX019, an Allogeneic CAR NK for the Treatment of Relapsed/Refractory (R/R) B-Cell Malignancies
June 14 – June 16, 2023
Abstract 389
Abstract titles are available on the 17-ICML website.
Abstracts are expected to be available on the ICML website on June 9, 2023 at 5:59 p.m. ET.

The presentations will be made available electronically on the Nkarta website following their delivery at the scheduled scientific sessions.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.

On May 11, 2023 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company developing Stealth Editors to perform in vivo gene editing without triggering the immune system, reported its financial results for the three-month period ended March 31, 2023 and other recent developments (Press release, NeuBase Therapeutics, MAY 11, 2023, View Source [SID1234631525]).

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"To date in 2023, we have made steady progress advancing the development of our gene editing application based on our PATrOL platform. One of the main drivers behind the initial success of this application area, and speed at which we are moving forward, is the ability to leverage our extensive experience in peptide nucleic acids ("PNAs"), the chemistry which forms the core of our platform. PNAs have been shown to engage the double-stranded human genome due to their high binding affinity and exquisite sequence selectivity. This chemistry would allow us to tag a locus in the genome that harbors a mutation with a simple synthetic compound and recruit the cell’s own machinery to repair the mutation. This is the approach behind our in vivo gene editing platform," stated Dietrich A. Stephan, Ph.D., Founder and Chief Executive Officer of NeuBase. "We believe our Stealth Editors can potentially address up to 90% of disease-causing mutations, compared to the estimated approximately 20% addressed by base editing platforms currently in development. In addition, our approach to gene editing offers several benefits that differentiate us from CRISPR/Cas editors, base editors, and prime editors. For example, Stealth Editors are non-immunogenic and have exquisite fidelity, maximizing the ability to re-dose should durability wane over time, which is a situation we have seen with gene therapy approaches in the past."

"Throughout the remainder of the year we look forward to presenting initial ex vivo and in vivo editing results against high-value genetic mutations, together with associated performance metrics, such as fidelity and efficiency. This includes preclinical data in two oral presentations the NeuBase team will provide at the ASGCT (Free ASGCT Whitepaper) 26th Annual Meeting taking place next week. We plan to follow up the presentations with an investor and analyst conference call on May 22, 2023 to discuss these data," concluded Dr. Stephan.

First Quarter of 2023 and Recent Operating Highlights

Gene Editing Program:

The Company is advancing development of the differentiated gene editing capabilities of its PATrOL platform and development of Stealth Editors.
Two abstracts accepted for oral presentations at the ASGCT (Free ASGCT Whitepaper) 26th Annual Meeting, which is being held in Los Angeles, CA and virtually on May 16-20, 2023. Management plans to hold an investor and analyst conference call on May 22, 2023.

Details of the gene editing pipeline expected to be provided during 2023.
Gene Editing Research Agreements:
The Company’s previously announced collaboration with a global healthcare company to evaluate the PATrOL platform for three monogenic genetic diseases remains on track. The global healthcare company will have the exclusive opportunity, subject to certain terms and conditions, to license and develop the drug candidates created under this research evaluation agreement.
Engaged in discussions with other healthcare companies on the potential for additional research agreements.
Gene Silencing Pipeline Collaborations:
NeuBase continued active pursuit of collaborative initiatives, including partnerships, for the Company’s myotonic dystrophy type 1, Huntington’s disease, and KRAS (G12D and G12V) programs. The Company currently expects that any collaborations that could result from these discussions would be announced in the second half of 2023.
Financial Results for the Quarter Ended March 31, 2023

As of March 31, 2023, the Company had cash and cash equivalents of approximately $13.8 million, compared with approximately $17.4 million as of December 31, 2022.
NeuBase estimates its current cash and cash equivalents are sufficient to fund currently planned operating and capital expenditures into the second quarter of 2024.

For the quarter ended March 31, 2023, the Company reported a net loss of approximately $4.1 million, or a net loss of $0.12 per share, compared with a net loss of approximately $9.9 million, or a net loss of $0.30 per share, for the same period last year.

For the quarter ended March 31, 2023, total operating expenses were approximately $4.2 million, consisting of approximately $2.9 million in general and administrative expenses and $1.3 million in research and development expenses. This compares with total operating expenses of approximately $9.9 million for the same period last year, consisting of approximately $3.1 million in general and administrative expenses and $6.8 million in research and development expenses.

On April 21, 2023, the Company’s Board of Directors approved a change in its fiscal year from the twelve months beginning October 1 and ending September 30 to the twelve months beginning January 1 and ending December 31, which will be effective for the year ending December 31, 2023.