On May 11, 2023 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported its financial results for the first quarter ended March 31, 2023 (Press release, RAPT Therapeutics, MAY 11, 2023, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-first-quarter-2023-financial-results [SID1234631533]).

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"In 2023, we are continuing to focus on advancing our two lead programs, RPT193 and FLX475," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "In the first quarter, we expanded our RPT193 program with the initiation of a Phase 2a clinical trial in asthma. We continue to enroll our Phase 2b trial of RPT193 in atopic dermatitis and expect top line data from this trial in mid-2024. These two indications are the first of what we believe could be multiple indications amenable to RPT193 treatment. We also continue to enroll our Phase 2 trial of FLX475 in multiple cancer indications and anticipate providing an update in the second half of this year. Importantly, our cash position is strong and is expected to support our operations through mid-2025."

Financial Results for the First Quarter Ended March 31, 2023

Net loss for the first quarter of 2023 was $29.3 million, compared to $20.5 million for the first quarter of 2022.

Research and development expenses for the first quarter of 2023 were $25.6 million, compared to $16.7 million for the same period in 2022. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and early stage programs, as well as increases in personnel expense, lab supplies, facilities and stock-based compensation expense, partially offset by lower development costs related to FLX475.

General and administrative expenses for the first quarter of 2023 were $6.0 million, compared to $4.7 million for the same period in 2022. The increase in general and administrative expenses was primarily due to increases in expenses for personnel, stock-based compensation, facilities and professional services.

As of March 31, 2023, the Company had cash, cash equivalents and marketable securities of $231.6 million.

On May 11, 2023 Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, reported its financial results for the first quarter ended March 31, 2023, along with an update on the Company’s key corporate highlights and upcoming milestones (Press release, Rain Oncology, MAY 11, 2023, View Source [SID1234631532]).

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"We remain excited for MANTRA’s topline data readout, which we continue to anticipate in the second quarter. We are hopeful these data will support a potential new therapeutic option for patients with dedifferentiated liposarcoma, and also assert the importance of p53’s role in the regulation of cancer," said Avanish Vellanki, co-founder and chief executive officer of Rain. "We continue to maintain strong fiscal prudence with tightly controlled cash burn on top of continued enrollment in MANTRA-2, and the anticipated, imminent start of the MANTRA-4 clinical trial."

First Quarter 2023 Key Research and Development (R&D) Highlights and Upcoming Milestones

· Phase 3 Dedifferentiated Liposarcoma (DDLPS) Trial (MANTRA)
o Trial achieved required number of at least 105 progression events
o Company expects to announce topline data in the second quarter of 2023
o Company anticipates filing regulatory applications in the United States and other regions globally, subject to supportive clinical topline data readout

· Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors (n=65)
o Clinical trial continues to enroll across solid tumors with MDM2 copy number greater than or equal to 8

· Phase 1/2 Basket Trial (MANTRA-4) in Advanced Solid Tumors Exhibiting Loss of the CDKN2A Gene
o Company expects to commence trial in mid-2023, which will evaluate the combination of milademetan with Roche’s FDA-approved immune-oncology therapy, atezolizumab in 30 patients who have previously failed or progressed on immunotherapy

Our updated corporate presentation is available at the "Corporate Presentation" section of the Rain website.

First Quarter 2023 Financial Results

For the three months ended March 31, 2023, Rain reported a net loss of $20.5 million, as compared to a net loss of $17.4 million for the same period in 2022. Net loss per share for the three months ended March 31, 2023, was $0.56, as compared to a net loss per share of $0.66 for the same period in 2022.

Research and development (R&D) expenses were $16.7 million for the three months ended March 31, 2023, as compared to $13.6 million for the same period in 2022. The increase was primarily related to clinical trial costs for milademetan, higher payroll-related costs for our R&D personnel, and various other R&D costs for milademetan. Non-cash stock-based compensation expenses included in R&D expenses were approximately $1.1 million in the three months ended March 31, 2023, as compared to $0.9 million in the same period in 2022.

General and administrative (G&A) expenses were $5.1 million for the three months ended March 31, 2023, as compared to $3.9 million for the same period in 2022. The increase was primarily due to higher professional services costs and legal costs, as well as higher payroll-related costs. Non-cash stock-based compensation expense included in G&A expenses was approximately $0.4 million for each of the three months ended March 31, 2023 and 2022.

Total non-cash stock-based compensation expenses were approximately $1.6 million for the three months ended March 31, 2023, as compared to $1.2 million for the same period in 2022.

As of March 31, 2023, Rain had $109.8 million in cash, cash equivalents and short-term investments. Consistent with the prior quarter, Rain will not provide guidance on cash runway at this time. Rain will continue to assess its cash runway and provide further guidance in the next quarter, if appropriate, after the release of MANTRA topline results in this quarter.

As of March 31, 2023, Rain had approximately 36.4 million shares of common stock outstanding.

First Quarter 2023 Results Conference Call and Webcast Details

The management of Rain Oncology will host a conference call and webcast for the investment community today, May 11, 2023 at 2:00 pm PT (5:00 pm ET). A live webcast may be accessed here: View Source;tp_key=22d79acd4c. The conference call can be accessed by dialing (877) 704-4453 (domestic) or (201) 389-0920 (international). The passcode for the conference call is 13738120.

Replay of the call will be available by visiting the "Events" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

About Milademetan

Milademetan (also known as RAIN-32) is an oral small molecule inhibitor of the MDM2-p53 complex that reactivates p53. Milademetan has demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supported by a rationally designed dosing schedule to mitigate safety concerns and widen the potential therapeutic window of inhibition of the p53-MDM2 complex. Rain has completed enrollment in a Phase 3 trial of milademetan (MANTRA) in patients with LPS and anticipates topline data this quarter. In addition, milademetan is being evaluated in a Phase 2 tumor-agnostic basket trial in certain solid tumors with MDM2 amplification (MANTRA-2). Rain anticipates commencing a Phase 1/2 clinical trial to evaluate the safety, tolerability and efficacy of milademetan in combination with Roche’s atezolizumab in patients with loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and wildtype p53 advanced solid tumors (MANTRA-4), in mid-2023. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LPS.

On May 11, 2023 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, reported financial results for the quarter ended March 31, 2023, and provided a corporate update (Press release, Pyxis Oncology, MAY 11, 2023, View Source [SID1234631531]).

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Pyxis Oncology ended the first quarter of 2023 with approximately $150.8 million in cash, cash equivalents, restricted cash and short-term investments, which is expected to provide a runway into the first half of 2025, enabling the Company to evaluate early signs of potential clinical activity for PYX-201 and PYX-106 and initiate tumor-specific expansion cohorts following dose selection. Clinical sites are active and patient screening continues in the Phase 1 trial of PYX-106, referred to as PYX-106-101, and dosing is expected to begin during the second quarter of 2023. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for PYX-201 in pancreatic cancer, and subject dosing is underway in the Phase 1 trial of PYX-201, known as PYX-201-101.

"The first quarter of 2023 was marked by the transition of Pyxis Oncology to a clinical-stage company as we initiated two Phase 1 trials for PYX-201 and PYX-106," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "Receipt of ODD for PYX-201 in pancreatic cancer is an important achievement highlighting the need for new treatment options, and we remain focused on execution as our two clinical programs advance. We continue to anticipate preliminary data, including biomarker results and early signs of potential clinical activity, from both trials in the late-2023 to early-2024 timeframe."

Q1 2023 Financial Results

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As of March 31, 2022, Pyxis Oncology had cash and cash equivalents (including restricted cash) and short-term investments of $150.8 million (preliminary, unaudited), which is expected to fund operations into the first half of 2025. This cash balance reflects a one-time, $8 million payment to Pfizer, Inc. made during the first quarter related to the expansion of the license agreement for our Flexible Antibody Conjugation Technology (FACT) platform, which was announced in the fourth quarter of 2022.

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Research and development expenses were $11.9 million for the three months ended March 31, 2023, compared to $20.1 million for the three months ended March 31, 2022. The period-over-period decline was primarily due to inclusion of a $10 million license fee for PYX-106 in the first quarter of 2022 and lower contract manufacturing and preclinical costs, which were partially offset by increased clinical trial-related costs and personnel-related expenses due to higher clinical headcount.
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General and administrative expenses were $9.1 million for the three months ended March 31, 2023, compared to $11.3 million for the three months ended March 31, 2022. The period-over-period decrease was primarily due to a reduction in professional and consultant fees, which were mainly related to the first quarter 2022 build-out of our general and administrative function.
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Net loss was $19.2 million, or $0.54 per common share, for the three months ended March 31, 2023, compared to $31.4 million, or $0.97 per common share, for the three months ended March 31, 2022. Net losses for the quarters ended March 31, 2023 and 2022 included $4.9 million and $3.4 million, respectively, related to non-cash stock-based compensation expense.
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As of May 10, 2023, the outstanding number of shares of common stock of Pyxis Oncology was 38,245,287.

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.