PULSE BIOSCIENCES, INC. ANNOUNCES COMMENCEMENT OF RIGHTS OFFERING

On May 4, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported that it has commenced its previously announced rights offering of up to $15,000,000 of units (the "Units," and each, a "Unit") at the Initial Price (as defined below) (Press release, Pulse Biosciences, MAY 4, 2022, View Source [SID1234613554]). The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m., Eastern Time, on May 23, 2022 (the "Expiration Date").

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Pursuant to the rights offering, Pulse Biosciences is distributing non-transferable subscription rights to purchase the Units to each holder of the Company’s common stock, par value $0.001 per share ("Common Stock"), as of April 25, 2022. Each Unit consists of one share of Common Stock and a warrant to purchase one share of Common Stock. The subscription price per Unit shall be equal to the lesser of (i) $3.72 per Unit (the "Initial Price") or (ii) the volume weighted average price of the Company’s Common Stock for the five trading day period through and including the Expiration Date (the "Alternate Price"). The subscription price will determine the final number of Units issuable, and subsequently the pro rata number of Units to which stockholders can subscribe. Each warrant will be exercisable for one share of the Company’s Common Stock at an exercise price that shall be equal to the subscription price for the Units. The Common Stock and the warrants comprising the Units will separate upon the closing of the rights offering and will be issued separately; however, they may only be purchased as a Unit and the Units will not trade as a separate security.

Stockholders wishing to exercise subscription rights must timely pay $3.72 per Unit, the Initial Price, for the number of Units they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional Units in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional Units that are not purchased by other stockholders, on a pro rata basis and subject to availability.

The rights offering is being made pursuant to the Company’s shelf registration statement on Form S-3, which was deemed effective by the Securities and Exchange Commission (the "SEC") on August 21, 2020, including the prospectus contained therein as modified by the prospectus supplement containing the detailed terms of the rights offering filed with the SEC on May 4, 2022. Copies of the foregoing documents may be obtained at the SEC’s website at www.SEC.gov. Questions about the rights offering and requests for copies of the prospectus and prospectus supplement relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information, subscription and warrant agent for the rights offering, at the address and phone number provided at the end of this release.

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

First Patient Dosed in Phase II Renal Cancer Theranostics Study

On May 4, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that a first patient has been dosed in the ‘STARLITE 2’ Phase II study of the Company’s investigational renal cancer therapy, TLX250 (177Lu-DOTA-girentuximab), at Memorial Sloan Kettering Cancer Center (MSK) in New York (Press release, Telix Pharmaceuticals, MAY 4, 2022, View Source [SID1234613572]).

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STARLITE 2 (NCT05239533) will assess the efficacy of TLX250 targeted radiation in combination with immunotherapy for clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. TLX250 targets carbonic anhydrase IX (CA9),[1] a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy.[2] The concept is that low doses of targeted radiation can potentially overcome immune resistance – or "immune prime" a tumour and therefore make it more responsive to cancer immunotherapy.

This Phase II study, in patients who have progressed following prior immunotherapy, will evaluate TLX250-delivered radiation in combination with the anti-PD-1[3] immunotherapy Opdivo[4] (nivolumab). The primary endpoint is to determine the safety and efficacy of combination therapy with TLX250 as assessed by the tumours responding to the Telix therapy versus the current standard of care alone. Telix’s investigational companion imaging agent TLX250-CDx (89Zr-DFO-girentuximab) will also be used in the study to image CA9 expression. The single-arm investigator-led study is expected to enrol approximately 30 patients.

Telix Chief Medical Officer, Dr. Colin Hayward noted, "The integration of precision nuclear medicine and medical oncology is underway and Telix is at the forefront of this movement to develop personalised products and patient-friendly regimens. We wish to express our gratitude to Dr. Darren Feldman and his clinical team, as well as the patients who will contribute to this ground-breaking study."

Disclosure: MSK has institutional financial interests related to Telix.

About TLX250

TLX250 (177Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets carbonic anhydrase IX (CA9), a cell surface protein that is highly expressed in several human cancers including ccRCC. High CA9 tumour expression is generally correlated with poor prognosis. Telix’s companion investigational diagnostic imaging agent TLX250-CDx (89Zr-DFO-girentuximab) is currently the subject of a global Phase III trial (ZIRCON trial, NCT03849118).

10-Q – Quarterly report [Sections 13 or 15(d)]

G1 Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Alector to Participate at the BofA Securities 2022 Healthcare Conference

On May 4, 2022 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported management will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on Thursday, May 12, 2022, at 11:20 a.m. PT (Press release, Alector, MAY 4, 2022, View Source [SID1234613472]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

Mirati Therapeutics Reports First Quarter 2022 Financial Results and Recent Corporate Updates

On May 4, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the first quarter of 2022 and recent corporate updates (Press release, Mirati, MAY 4, 2022, View Source [SID1234613520]).

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"Mirati continues to make significant progress across our pipeline, as we focus on executing our ambitious goals," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "This includes working toward our first potential commercial launch in the U.S. this year with adagrasib for the treatment of patients with previously-treated KRASG12C-mutated lung cancer and advancing the adagrasib program in earlier lines of therapy and across additional tumors. In addition, we completed enrollment of our Phase 3 trial evaluating sitravatinib in advanced lung cancer, continue to enroll patients in an ongoing Phase 1 study with our MTA cooperative PRMT5 inhibitor, MRTX1719, and continue to advance our novel preclinical programs. These milestones, combined with our strong financial position enable us to continue to invest in the advancement of our broad targeted oncology portfolio and prepare to become a successful commercial stage company."

Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)
•Announced two oral presentations at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Presentations to include full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with pre-treated non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation and late-breaking data on adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases.
•Presented preclinical data describing the mechanism of adagrasib CNS penetration at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data were simultaneously published in the journal of Clinical Cancer Research, which also included preliminary clinical experience in patients with active, untreated CNS metastases.
Sitravatinib (Potent TAM receptor inhibitor)
•Completed enrollment in the global, registrational Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO)1 in second or third line non-squamous NSCLC. The Company expects to reach the number of events needed to trigger an interim analysis of overall survival in Q4 2022.
MRTX1719 (MTA Cooperative PRMT5 inhibitor)
•Enrolling patients in an ongoing Phase 1 dose escalation cohort of the Company’s investigational MTA-cooperative PRMT5 inhibitor, MRTX1719, with initial clinical data expected in 2023.
1

MRTX1133 (Potent and selective KRASG12D inhibitor)
•Presented preclinical results on the pharmacogenomics of the Company’s investigational KRASG12D inhibitor, MRTX1133, at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The Company plans to file an IND application for this program in the second half of 2022.
MRTX0902 (Potent SOS-1 inhibitor)
•Presented preclinical results on the design and discovery of the Company’s investigational SOS1 inhibitor, MRTX0902, at the 2022 AACR (Free AACR Whitepaper) Annual Meeting. The Company expects to file an IND application for this program in the second half of 2022.
First Quarter 2022 Financial Results
•Ended the first quarter with approximately $1.3 billion in cash, cash equivalents, and short-term investments.
•Research and development expenses for the first quarter of 2022 were $131.0 million, compared to $104.1 million for the same period in 2021. The increase in research and development expenses is primarily due to an increase in salaries and other employee-related expense, which includes an increase in share-based compensation expense, an increase in expense associated with the development of adagrasib, sitravatinib and MRTX1719, an increase in preclinical and early discovery activities, as well as an increase in other research and development costs, offset by a decrease in expense for MRTX1133. The Company recognized research and development-related share-based compensation expenses of $26.3 million during the first quarter of 2022, compared to $14.5 million for the same period in 2021.
•General and administrative expenses for the first quarter of 2022 were $54.0 million, compared to $28.4 million for the same period in 2021. The increase is due to an increase in salaries and other employee-related expenses, which includes an increase in share-based compensation expense, an increase in professional services expense primarily associated with commercial scale up, an increase in insurance, rent and other facilities-related costs. The Company recognized general and administrative-related share-based compensation expenses of $16.6 million in the first quarter of 2022, compared to $10.2 million for the same period in 2021.
•Net loss for the first quarter of 2022 was $188.4 million, or $3.40 per share basic and diluted, compared to a net loss of $135.7 million, or $2.67 per share basic and diluted for the same period in 2021.
Conference Call Information
There will be a conference call on May 4, 2022 at 4:30 p.m. ET/ 1:30 p.m. PT during which company executives will review financial information for the first quarter of 2022 and provide a corporate update.
Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 313-209-4906 or international +1 800-406-5356, confirmation code: 6391007.
A replay of the call will be available approximately 2 hours after the event has ended at the same website.