On June 28, 2023 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported that it has entered into a definitive agreement with a single institutional investor for the purchase and sale of an aggregate of 5,000,000 shares of its common stock (or common stock equivalents in lieu thereof), at a purchase price of $0.45 per share of common stock (or common stock equivalent in lieu thereof), in a registered direct offering (Press release, Sonnet BioTherapeutics, JUN 28, 2023, View Source [SID1234632968]). The Company has also agreed to issue to the investor, in a concurrent private placement, warrants to purchase up to an aggregate of 5,000,000 shares of common stock. The warrants will have an exercise price of $0.6749 per share, are exercisable six months from issuance, and will expire three and one-half years from the date of issuance. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about June 30, 2023, subject to the satisfaction of customary closing conditions.

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Chardan is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the registered direct offering and the concurrent private placement are expected to be approximately $2.25 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds for research and development, including clinical trials, working capital and general corporate purposes.

The securities described above (excluding the warrants and the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-251406) that was originally filed with the Securities and Exchange Commission (the "SEC") on December 17, 2020, and declared effective on December 29, 2020. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from Chardan Capital Markets, LLC, 17 State Street, Suite 2130, New York, New York 10004, at (646) 465-9000, or by email at [email protected].

The warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock 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 Act and such applicable state securities laws.

On June 28, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications, reported topline clinical data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor nivolumab (Opdivo) in patients with malignant pleural mesothelioma (MPM) who were either refractory to or relapsed after at least one line of the standard of care therapy (Press release, Sellas Life Sciences, JUN 28, 2023, View Source [SID1234632967]).

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Nine of the ten patients enrolled received at least three doses of GPS, with the third GPS dose given in combination with nivolumab. All enrolled patients had either received and progressed with or were refractory to frontline pemetrexed-based chemotherapy. Additional immune response data from all ten patients is expected by Q4 2023.

The study details are as follows:

70.3 weeks (17.6 months) median overall survival (OS) in patients who received the combination therapy (9/10 patients) and 54.1 weeks (13.5 months) for all ten patients (nine patients with combination therapy and one GPS only patient). Median overall survival for patients who entered the study as Stage IV patients was 62.3 weeks (15.6 months). OS was calculated as the time from cessation of the most recent previous therapy until confirmed death or most recent data update for patients who are still alive (40 percent of patients)
11.9 weeks median progression-free survival (PFS) for all patients
30% disease control rate (DCR) with three patients achieving stable disease per RECIST criteria with the tumor volume decrease of up to 17%. DCR is the sum of overall response rate and rate of stable disease.
As expected in this high-risk advanced cancer population, all patients experienced adverse events, unrelated and related. Seven out of ten patients (70%) had treatment related toxicities and six (60%) had nivolumab related toxicities. Grade 3 (G3) and higher toxicities were observed in three patients (30%). None of the G3 and higher toxicities were related to GPS. GPS related toxicities were observed in three patients (30%), all were Grade 1 (G1) and included G1 skin induration at the site of injection/injection site reaction and/or fatigue in two patients and G1 dizziness and non-cardiac chest pain, each in one patient.
Of the ten evaluable patients, eight were male and two were female, with a median age of 69 years. Sixty percent of entered the study as Stage III or IV patients. Initial tumor stages were I (one patient), II (three patients), III (two patients) and IV (four patients).
All patients had MPM epithelioid and/or sarcomatoid variant, a tumor which universally expresses Wilms Tumor 1 (WT1), one of the most widely expressed cancer antigens, ranked by the National Cancer Institute as the top priority among cancer antigens for immunotherapy.
"In our GPS trials completed in previous years we have observed and reported increased survival in the maintenance therapy setting, which is the primary setting for our GPS therapy. This year, we have seen in two studies where GPS appears to increase the survival benefit in active disease when combined with checkpoint blockade drugs, one with relapsed/refractory WT1 positive ovarian cancer and now in relapsed/refractory WT1 positive mesothelioma. We believe that these observed survival benefits in the active disease setting further confirms strong biological effect of GPS in even the most challenging settings," said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO, SELLAS. "This is demonstrated by a very promising disease control rate where GPS seems to contribute to stopping progression of extremely aggressive cancers."

"It is important to note that the positive survival outcomes seen in this study are accompanied with a safety profile which is similar to that of the checkpoint inhibitor alone," commented Dragan Cicic, MD, SVP Clinical Development, SELLAS. "It is rare for a drug used to treat advanced cancers to result in no toxicities higher than Grade 1. Interestingly, patients in this trial in whom low toxicities were observed all had survival at the median or higher."

About MPM
With approximately 3,300 cases in the United States each year, accompanied by a rising incidence in developing countries, MPM is notoriously difficult to treat and can lead to poor clinical outcomes with respect to both OS and PFS, especially for those patients with the sarcomatoid variant who show a median OS of approximately 4.0 to 5.0 months. In relapsed and refractory patients who progressed after the first line standard of care pemetrexed, a similar patient population to that in the GPS nivolumab combination trial, the common treatment regimen is vinorelbine and OS in those patients is reported to be between 4.5 and 6.2 months. In patients treated with other chemotherapy regimens, such as carboplatin and irinotecan, median OS is reported to be approximately 7.0 months.

On June 28, 2023 Roivant (Nasdaq: ROIV) reported its financial results for the fourth quarter and fiscal year ended March 31, 2023, and provided an update on the business (Press release, Roivant Sciences, JUN 28, 2023, View Source [SID1234632966]).

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Roivant’s Chief Executive Officer, Matt Gline, noted: "I’m incredibly pleased with the progress we’ve made in recent months. Last week, we reported RVT-3101 data from the chronic period of TUSCANY-2, our Phase 2b study in ulcerative colitis. These data surpassed our expectations, demonstrating improvement from the induction period at week 14 to the chronic period at week 56 across all key efficacy endpoints for patients treated with the expected Phase 3 dose. In addition, earlier this spring we announced positive topline results for VTAMA’s ADORING 1 and ADORING 2 Phase 3 trials in atopic dermatitis. The results reported across both studies showed efficacy comparable to that of many systemic products, and we feel VTAMA has the potential to be a safe and efficacious topical option for adults and children as young as 2 years old. Finally, we reported strong growth in VTAMA revenue this past quarter in psoriasis with over 75% of US commercial lives now covered. These recent developments, combined with our strong balance sheet, continue to support Roivant’s growing leadership in the treatment of immunological and inflammatory disease, and we are proud of our continued track record in clinical execution."

Recent Developments

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Dermavant: For the quarter and fiscal year ended March 31, 2023, Roivant reported VTAMA net product revenue of $13.7 million and $28.0 million, respectively, representing a 25% gross-to-net yield for the quarter. As of June 2023, over 170,000 VTAMA prescriptions have been written by approximately 11,000 unique prescribers for psoriasis, based on IQVIA data. Coverage has been expanded to 125 million US commercial lives, representing 76% of the total. VTAMA met the primary and all secondary endpoints in two Phase 3 studies, evaluating 813 moderate-to-severe atopic dermatitis patients. Importantly, no new safety or tolerability signals were observed in this population, which included children as young as 2 years old.

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Immunovant: In May 2023, Immunovant announced its Investigational New Drug (IND) application and Clinical Trial Application (CTA) for IMVT-1402 were cleared by the FDA and MEDSAFE, respectively, and its Phase 1 clinical trial in healthy subjects was initiated in New Zealand. Additionally, a Phase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease (GD) was initiated.

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Telavant: In June 2023, Telavant reported positive data from the chronic period of TUSCANY-2, a large, global Phase 2b study evaluating RVT-3101 for the treatment of ulcerative colitis. Outcomes were measured at week 56 for the chronic period (vs. week 14 from the previously reported induction period). At the expected Phase 3 dose in the overall population and in the biomarker positive populations, RVT-3101 treatment produced clinically meaningful efficacy results with improved Clinical Remission, Endoscopic Improvement, and Endoscopic Remission at week 56.

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Roivant: Roivant reported its consolidated cash, cash equivalents and restricted cash of $1.7B at March 31, 2023, supporting cash runway into the second half of calendar year 2025.

Major Upcoming Milestones

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Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024.

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Immunovant expects IMVT-1402 Phase 1 initial data from single-ascending dose cohorts in August/September 2023 and initial data from multiple-ascending dose cohorts in October/November 2023. Additionally, for batoclimab: top-line results from the ongoing myasthenia gravis (MG) trial are expected in the second half of calendar year 2024. Top-line results from the Phase 3 thyroid eye disease (TED) program, consisting of two Phase 3 clinical trials, are expected in the second half of calendar year 2025. Initial data from period 1 of the Phase 2B trial in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected to be available in the first half of calendar year 2024. Initial results from the Phase 2 proof-of-concept trial in GD are expected in the fourth quarter of calendar year 2023.

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Telavant has initiated a Phase 2 dose-ranging study of RVT-3101 in Crohn’s disease with data expected in the fourth quarter of calendar year 2024.

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Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with systemic lupus erythematosus (SLE) in the fourth quarter of calendar year 2023. Priovant also expects to announce topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.

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Hemavant plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk myelodysplastic syndromes (MDS) patients in the second half of calendar year 2023.

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Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024.

Matt Gline added: "I am incredibly pleased to welcome Meghan FitzGerald to our Board of Directors. Meghan’s deep expertise in healthcare and her extraordinary commitment to patients will be invaluable to Roivant’s mission to accelerate the development and commercialization of medicines that matter."

Fourth Quarter and Fiscal Year Ended March 31, 2023, Financial Summary

Cash Position

As of March 31, 2023, the company had cash, cash equivalents and restricted cash of approximately $1.7 billion.

Research and Development Expenses

Research and development (R&D) expenses decreased by $3.2 million to $131.9 million for the three months ended March 31, 2023, compared to $135.1 million for the year ended March 31, 2022, primarily due to decreases in share-based compensation of $11.9 million and other expenses of $3.7 million, partially offset by an increase in program specific costs of $12.3 million, largely driven by the anti-FcRn franchise.

Non-GAAP R&D expenses were $126.0 million for the three months ended March 31, 2023, compared to $117.8 million for the three months ended March 31, 2022.

R&D expenses increased by $42.2 million to $525.2 million for the year ended March 31, 2023, compared to $483.0 million for the year ended March 31, 2022, primarily due to increases in program-specific costs of $45.8 million and personnel-related expenses of $28.1 million, partially offset by a decrease in share-based compensation of $32.8 million. The increase of $45.8 million in program-specific costs largely reflects the progression of our programs and drug discovery, including the anti-FcRn franchise, RVT-2001, brepocitinib, and RVT-3101. The asset acquisitions of brepocitinib, RVT-2001, and RVT-3101 were completed in September 2021, November 2021, and November 2022, respectively. Increases in program-specific costs were partially offset by certain decreases, including $19.3 million for tapinarof, which was primarily due to the completion of ADORING 1 and ADORING 2 phase 3 atopic dermatitis clinical trials during the year ended March 31, 2023. The increase of $28.1 million in personnel-related expenses largely reflects the progression of our programs, particularly the anti-FcRn franchise. The decrease of $32.8 million in share-based compensation expense was primarily due to the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination in September 2021, resulting in the recognition of a one-time catch-up expense of $22.9 million relating to cumulative service rendered between the grant date of the respective awards and completion of the Business Combination and continued recognition of expense over the requisite service periods.

Non-GAAP R&D expenses were $489.2 million for the year ended March 31, 2023, compared to $416.1 million for the year ended March 31, 2022.

Acquired In-Process Research and Development Expenses

There was no acquired in-process research and development (IPR&D) expense for the three months ended March 31, 2023. Acquired IPR&D expenses were $1.5 million for the three months ended March 31, 2022.

Acquired IPR&D expenses decreased by $42.1 million to $97.7 million for the year ended March 31, 2023, compared to $139.9 million for the year ended March 31, 2022. The decrease was primarily due to higher consideration for the purchase of IPR&D during the year ended March 31, 2022 as a result of consideration for the purchase of IPR&D of $82.1 million relating to the acquisition of brepocitinib, a one-time milestone expense of approximately $39 million due to the achievement of a development milestone related to tapinarof, and consideration for the purchase of IPR&D of $14.1 million relating to the acquisition of RVT-2001. Acquired IPR&D expenses for the year ended March 31, 2023, was driven by consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of RVT-3101 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses decreased by $13.5 million to $125.5 million for the three months ended March 31, 2023, compared to $139.0 million for the three months ended March 31, 2022. The decrease was primarily due to a decrease in share-based compensation of $40.0 million, partially offset by higher SG&A expenses at Dermavant as a result of the commercial launch of VTAMA.

Non-GAAP SG&A expenses were $102.6 million for the three months ended March 31, 2023, compared to $77.3 million for the three months ended March 31, 2022.

SG&A expenses decreased by $174.5 million to $600.5 million for the year ended March 31, 2023, compared to $775.0 million for the year ended March 31, 2022. The decrease was primarily due to a decrease in share-based compensation expense of $314.6 million, partially offset by higher SG&A expenses at Dermavant as a result of the commercial launch of VTAMA. The decrease in share-based compensation resulted from the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination in September 2021, resulting in the recognition of a one-time catch-up expense of $350.0 million for the year ended March 31, 2022, for cumulative service rendered between the grant date of the respective awards and completion of the Business Combination.

Non-GAAP SG&A expenses were $407.6 million for the year ended March 31, 2023, compared to $271.1 million for the year ended March 31, 2022.

Loss from Continuing Operations

Loss from continuing operations was $175.4 million for the three months ended March 31, 2023, compared to $291.3 million for the three months ended March 31, 2022. On a per common share basis, loss from continuing operations was $0.20 for the three months ended March 31, 2023, and $0.39 for the three months ended March 31, 2022. Non-GAAP loss from continuing operations was $189.4 million for the three months ended March 31, 2023, compared to $187.7 million for the three months ended March 31, 2022.

Loss from continuing operations was approximately $1.2 billion for the year ended March 31, 2023, compared to $924.1 million for the year ended March 31, 2022. On a per common share basis, loss from continuing operations was $1.58 for the year ended March 31, 2023, and $1.26 for the year ended March 31, 2022. Non-GAAP loss from continuing operations was $924.3 million for the year ended March 31, 2023, compared to $784.2 million for the year ended March 31, 2022.

On June 28, 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 that it has entered into definitive agreements for the issuance and sale of an aggregate of 578,697 of its shares of common stock (or common stock equivalents) in a registered direct offering at a purchase price of $2.57 per share (or common stock equivalent) and associated unregistered warrants (Press release, NeuBase Therapeutics, JUN 28, 2023, View Source [SID1234632965]). In a concurrent private placement, NeuBase has also agreed to issue and sell an aggregate of 1,366,829 of its shares of common stock (or common stock equivalents), at the same purchase price of $2.57 per share (or common stock equivalent) and associated unregistered warrants as in the registered direct offering. In addition, the Company has agreed to issue in the offerings unregistered Series A warrants to purchase up to an aggregate of 1,945,526 shares of common stock and unregistered short-term Series B warrants to purchase up to an aggregate of 1,945,526 shares of common stock. The registered direct offering and the private placement were priced at-the-market under Nasdaq rules.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.

Each series of unregistered warrants will have an exercise price $2.32 per share and become exercisable immediately upon issuance. The Series A warrants will have a term of five and one-half years from the date of issuance and the short-term Series B warrants will have a term of eighteen months from the date of issuance.

The offerings are expected to close on or about June 30, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the concurrent offerings are expected to be approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by NeuBase. NeuBase currently intends to use the net proceeds from the offerings for working capital and general corporate purposes.

The securities offered in the registered direct offering (but excluding the securities offered in the private placement and the shares of common stock underlying the unregistered warrants issued in the registered direct offering) are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-254980), including a base prospectus, previously filed with the Securities and Exchange Commission (the "SEC") on April 1, 2021 and declared effective by the SEC on April 14, 2021. The offering of the securities to be issued in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source When available, electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the securities in the private placement and the unregistered warrants described above are being made in transactions not involving a public offering and have not been registered pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the private placement, the unregistered warrants and underlying shares of common stock may not be reoffered or resold 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.

NeuBase has agreed to file an initial registration statement with the SEC covering the resale of the securities to be issued in the private placement no later than 30 days following the date of the definitive agreement and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after the date of the definitive agreement in the event of a "full review" by the SEC.

On June 28, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the Company has been awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001, a second-generation photodynamic therapy photosensitizer agent for the treatment of cutaneous metastatic breast cancer (CMBC) (Press release, Kintara Therapeutics, JUN 28, 2023, View Source [SID1234632964]).

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"We are delighted that the National Institutes of Health recognizes that Kintara’s REM-001 program shows an opportunity to address an unmet medical need by significantly improving the quality of life and reducing co-morbidities for patients with CMBC," said Robert E. Hoffman, President and CEO of Kintara. "The support from the NIH validates the potential of our program to help patients with metastatic breast cancer who have little or no treatment options for this devastating disease. We look forward to advancing our REM-001 program with this grant."

Funds from the NIH SBIR grant will enable Kintara to restart the REM-001 CMBC program and generate clinical evidence to demonstrate proof of concept for the photodynamic therapy platform in CMBC. Completion of this study is intended to aid in the design of a planned phase 3 registrational study.

A 2003 meta-analysis of over 20,000 cancer patients found that 24% of breast cancer patients included in the analysis had developed cutaneous metastases, which was the highest rate of any cancer type. According to the American Cancer Society’s estimates for 2021, it was projected that there would be approximately 281,550 new cases of invasive breast cancer diagnosed in women in the United States. Accordingly, the prevalence of CMBC may be in excess of 50,000 cases annually in the United States.