On May 4, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, Deciphera Pharmaceuticals, MAY 4, 2022, View Source [SID1234613471]).

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"We have made significant progress on our 2022 goals so far this year, demonstrating our commercial success with QINLOCK, strengthening our balance sheet, and rapidly advancing our potential best-in-class and first-in-class clinical-stage pipeline," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "The strong commercial launch of QINLOCK in Germany underscores the long-term potential for this medicine to benefit patients with GIST around the world. The pivotal Phase 3 MOTION study of vimseltinib, which we are developing for the treatment of tenosynovial giant cell tumor, or TGCT, is now enrolling patients and we expect to present updated results from the Phase 1/2 study in patients with TGCT in the second half of this year."

Mr. Hoerter continued, "We are very excited about our potential first-in-class autophagy pathway inhibitor, DCC-3116. At this year’s AACR (Free AACR Whitepaper) Annual Meeting, we presented encouraging preclinical data for DCC-3116 in combination with KRASG12C inhibitors highlighting the broad potential of this product candidate to benefit patients. We expect to present initial data from the single agent dose escalation portion of the Phase 1 study later this year."

First Quarter 2022 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $28.8 million in QINLOCK net product revenue in the first quarter of 2022, including $23.4 million in U.S. net product revenue and $5.4 million in international net product revenue.
Launched in Germany and received authorization for the post-approval paid access program in France.
Received a favorable ASMR III rating for QINLOCK from the Transparency Commission of the French National Authority for Health.
Vimseltinib

Continued enrollment and site activation in the pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT. MOTION is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with TGCT who are not amenable to surgery. The primary endpoint of the study is objective response rate at week 25 as measured by RECIST v1.1 by blinded independent central review.
Expects to present updated results from the ongoing Phase 1/2 study in TGCT patients in the second half of 2022.
DCC-3116

Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022.
The results showed that treatment of mutant KRASG12C NSCLC cell lines with KRASG12C inhibitors sotorasib and adagrasib induced autophagy via activation of ULK1/2 kinases as measured by an increase in ULK-mediated phosphorylation of the key ULK autophagy substrate ATG13 and resulting increase in autophagic flux.
DCC-3116 in combination with KRASG12C inhibitors translated to deeper and longer tumor regressions in mutant KRASG12C NSCLC models in vivo than with KRASG12C inhibitors alone.
Expects to present data in the second half of 2022 from the single agent dose escalation portion of the Phase 1 study of DCC-3116 in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.
Expects to initiate three Phase 1b study combination dose escalation cohorts in the second half of 2022:
In combination with trametinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations.
In combination with binimetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations, subject to feedback from regulatory authorities.
In combination with sotorasib, an FDA- approved KRASG12C inhibitor, in patients with advanced or metastatic solid tumors with KRASG12C mutations, subject to feedback from regulatory authorities.
Expects to present additional preclinical data for DCC-3116 in the second half of 2022 and continue to explore preclinical combinations with multiple additional anti-cancer agents with diverse mechanisms of action.
Proprietary Drug Discovery Platform

Expects to nominate a development candidate in 2022 from the pan-RAF inhibitor research program discovered using the Company’s novel switch-control inhibitor platform.
Corporate Updates

Announced the closing in April 2022 of an underwritten public offering of 7,501,239 shares of the Company’s common stock at a public offering price of $10.00 per share and, in lieu of common stock to certain investors, the Company issued pre-funded warrants to purchase 9,748,761 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant. The shares of common stock sold include 2,250,000 shares pursuant to the option granted by the Company to the underwriters, which option was exercised in full. This offering resulted in net proceeds of $163.4 million after deducting underwriting discounts and commissions and other offering expenses.
First Quarter 2022 Financial Results

Revenue: Total revenue for the first quarter was $29.2 million, which includes $28.8 million of net product revenue of QINLOCK and $0.4 million of collaboration revenue compared to $25.2 million of total revenue, including $20.0 million of net product revenue of QINLOCK and $5.2 million of collaboration revenue, for the same period in 2021.
Cost of Sales: Cost of sales were $0.4 million in the first quarter ended March 31, 2022 compared to $0.2 million in the same period in 2021. Cost of sales for newly launched products will not include the full cost of manufacturing until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. Deciphera does not expect the cost of sales as a percentage of net sales of QINLOCK to increase significantly after the Company has sold all zero cost inventories and commenced the sales of inventories that will reflect the full cost of manufacturing. The Company expects to continue to sell zero cost inventories of QINLOCK in the U.S. during 2022.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $47.4 million, compared to $55.7 million for the same period in 2021. The decrease was primarily due to lower clinical trial costs related to QINLOCK, including INTRIGUE, our Phase 3 study for the treatment of second-line GIST for which top-line results were announced in November 2021, and the discontinuation of our rebastinib program following the corporate restructuring implemented in the fourth quarter of 2021, partially offset by an increase in clinical trial costs related to our Phase 1 study of DCC-3116, preclinical costs, and personnel costs. Non-cash, stock-based compensation was $6.3 million and $5.0 million for the first quarters of 2022 and 2021, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2022 were $28.3 million, compared to $30.7 million for the same period in 2021. The decrease was primarily due to a decrease in professional and consultant fees. Non-cash, stock-based compensation was $8.0 million and $6.2 million for the first quarters of 2022 and 2021, respectively.
Net Loss: For the first quarter of 2022, Deciphera reported a net loss of $46.9 million, or $0.80 per share, compared with a net loss of $61.3 million, or $1.06 per share, for the same period in 2021.
Cash Position: As of March 31, 2022, cash, cash equivalents, and marketable securities were $275.4 million, compared to $327.6 million as of December 31, 2021. In April 2022, the Company completed an underwritten public offering that resulted in aggregate net proceeds of $163.4 million. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2025.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 4, 2022 at 8:00 AM ET. The conference call may be accessed by dialing (877) 270-2148 (domestic) or (412) 902-6510 (international). A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On May 4, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported financial results for the quarter ended March 31, 2022 (Press release, Allogene, MAY 4, 2022, View Source [SID1234613519]).

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"This month marks the fourth anniversary of Allogene. I am immensely proud of all that we have accomplished in such a short period of time, including our ability to treat more patients with our pipeline of AlloCAR T candidates than anyone else in the field," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Every advance we make in manufacturing, clinical development, and research brings us one step closer to achieving our vision of making CAR T therapy accessible to all eligible patients."

Corporate Highlights
Cell Forge 1 (CF1), Allogene’s commercial scale manufacturing facility located in Newark, California is now operational and producing GMP material with the intent of supplying ALLO-501A for the planned pivotal study as well as other clinical trials. CF1 is projected to have the ability to manufacture approximately 20,000 ALLO-501A AlloCAR T doses annually at scale.

In March, the Company published its inaugural ESG report. The report details Allogene’s commitment to corporate integrity and sustainable business operations and highlights its priorities: employees, the environment, and patients, including increasing their access to potential life-saving products.

Pipeline Updates
Hematologic Malignancies
Enrollment in the Phase 1 ALLO-501A ALPHA2 trial in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) has re-opened with the goal of offering AlloCAR T to patients while the Company prepares to launch the pivotal Phase 2 ALPHA2 trial. The single-arm pivotal ALPHA2 trial of ALLO-501A in r/r LBCL is planned to initiate mid-2022. The single-arm ALPHA2 trial is on track to begin mid-year 2022 with FDA discussions directed at finalizing clinical trial design and Chemistry Manufacturing and Controls (CMC) requirements.

The EXPAND trial, planned to support registration of the lymphodepleting agent ALLO-647, is intended to demonstrate the contribution of ALLO-647 to the lymphodepletion regimen and benefit to patient outcomes.

Enrollment has also resumed in trials targeting BCMA for the treatment of patients with r/r multiple myeloma (MM), including the UNIVERSAL trial with ALLO-715 and the IGNITE trial with TurboCAR candidate, ALLO-605. During the quarter, preclinical data was published demonstrating the superior long-term in vitro myeloma-killing activity of allogeneic anti-BCMA
CAR T cells from healthy donors compared with anti-BCMA CAR T cells from patients with MM. The findings were published in Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

In May 2022, the Company was granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) for ALLO-605 for the treatment of MM.

The Company intends to provide an update on its CD19 and BCMA programs by the end of the year.

Solid Tumors
ALLO-316 is the Company’s first AlloCAR T candidate for solid tumors. The Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, anti-tumor efficacy, pharmacokinetics, and pharmacodynamics of ALLO-316 in patients with advanced or metastatic clear cell renal cell carcinoma (RCC). The trial, now in its second dose level cohort, continues to accrue patients.

In April, the Company presented preclinical data at the 2022 AACR (Free AACR Whitepaper) Annual Meeting which support the ongoing clinical evaluation of ALLO-316 for the treatment of patients with RCC and other CD70 expressing cancers. The findings were simultaneously published in AACR (Free AACR Whitepaper)’s Cancer Research.

In March, the FDA granted ALLO-316 Fast Track Designation (FTD) based on its potential to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies. Metastatic solid tumors have historically been a challenge regardless of treatment modality, and the five-year survival rate for patients with advanced kidney cancer is less than 15%, highlighting the need for innovation.

First Quarter Financial Results
•Research and development expenses were $60.2 million for the first quarter of 2022, which includes $11.1 million of non-cash stock-based compensation expense.
•General and administrative expenses were $19.9 million for the first quarter of 2022, which includes $11.2 million of non-cash stock-based compensation expense.
•Net loss for the first quarter of 2022 was $79.9 million, or $0.56 per share, including non-cash stock-based compensation expense of $22.3 million.
•The Company had $733.1 million in cash, cash equivalents, and investments as of March 31, 2022.

2022 Financial Guidance
•Allogene continues to expect full year GAAP Operating Expenses to be between $360 million and $390 million including estimated non-cash stock-based compensation expense of $90 million to $100 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 6579454. The webcast will be made
available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On May 4, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that it will host a first quarter 2022 investor call on Wednesday, May 11, 2022 at 8:00 AM EDT to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, MAY 4, 2022, View Source [SID1234613536]).

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To access the call, participants may dial (888) 428-7458 (Toll Free US & Canada) or (862) 298-0702 (International) at least five minutes prior to the start of the call. Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

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.

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).