On May 11, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported its financial results for the quarter ended March 31, 2023 and provided a business update (Press release, Phio Pharmaceuticals, MAY 11, 2023, View Source [SID1234631530]).

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"Expecting to commence the Phase 1 clinical trial in adoptive cell therapy (ACT) with our partner AgonOx, by the end of the second quarter of 2023 is the next major milestone in our development strategy," said Robert Bitterman, Phio Pharmaceuticals’ President and Chief Executive Officer. "The trial in collaboration with AgonOx is designed to assess safety and potential enhanced therapeutic benefit from the administration of Phio’s PH-762 treated ‘double positive’ CD8 tumor infiltrating lymphocytes (DP TIL) in patients with melanoma and other advanced solid tumors."

Recent Business Updates

Presented two abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in April, which included:
In vivo data showing that intratumoral administration of mPH-762 stimulated a local anti-tumor immune response and generated systemic tumor-reactive memory T cells. These data further support intratumoral use of PH-762 in the clinical setting, with deeper understanding of the mechanism of abscopal efficacy.
Pre-clinical data showing that intratumoral administration of dual-targeting PD-1/CTLA-4 INTASYL may provide an effective treatment option, with an improved safety profile compared to a combination PD-1/CTLA-4 systemic therapy.
Will be presenting an abstract at the American Society of Gene and Cell Therapy in May 2023, which includes:
Pre-clinical data demonstrating that using INTASYL to silence TIGIT and CBLB-B may be used to improve the anti-tumor response of NK cells, creating a more effective cell therapy for treating cancer.
Strengthened the balance sheet in April 2023 through an equity offering priced at-the-market under Nasdaq rules for net proceeds of approximately $1.7 million, after deducting placement agent fees and offering expenses.
Financial Results

Cash Position

At March 31, 2023, the Company had cash of $9.0 million as compared with $11.8 million at December 31, 2022. Subsequent to the end of the first quarter of 2023, the Company completed an equity offering of common stock and warrants for net proceeds of approximately $1.7 million, after deducting placement agent fees and offering expenses. The Company expects its current cash will be sufficient to fund currently planned operations into the first quarter of 2024.

Research and Development Expenses

Research and development expenses increased 35% to approximately $2.1 million for the quarter ended March 31, 2023 compared with approximately $1.6 million for the quarter ended March 31, 2022. The increase in research and development expenses was primarily driven by a ramp up in clinical-related expenses for the Company’s planned intratumoral and ACT clinical trials with PH-762 as compared to the prior year period. The Company anticipates research and development expenses to continue to increase as a result of clinical-related activities as our pipeline programs progress in clinical development.

General and Administrative Expenses

General and administrative expenses increased 39% to approximately $1.5 million for the quarter ended March 31, 2023 compared with approximately $1.1 million for the quarter ended March 31, 2022. The increase in general and administrative expenses was primarily due to increased professional service fees for legal, patent and public relations related services as compared to the prior year period.

Net Loss

Net loss increased 36% to approximately $3.6 million, or $3.15 per share, for the quarter ended March 31, 2023, compared with $2.6 million, or $2.34 per share, for the quarter ended March 31, 2022. The increase in net loss was primarily attributable to the increases in research and development and general and administrative expenses, as described above.

About INTASYL

INTASYL compounds are chemically modified siRNAs that provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity, targeting a broad range of cell types and tissues. INTASYL drugs are designed to precisely target specific proteins that reduce the body’s ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy (ACT) applications.

In comparison to biologics and cell and gene therapies, INTASYL has a favorable preclinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial dosing convenience to the prescriber and patient.

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

•
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.
•
R&D Expenses: Research and development (R&D) expenses were $22.1 million for the first quarter of 2023.
•
G&A Expenses: General and administrative (G&A) expenses were $8.1 million for the first quarter of 2023.
•
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.

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

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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.