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 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the first quarter of 2022 (Press release, Pacira Pharmaceuticals, MAY 4, 2022, View Source [SID1234613553]).

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First Quarter 2022 Financial Highlights

Total revenues of $158.0 million
Net product sales of $129.2 million for EXPAREL, $23.6 million for ZILRETTA, and $3.0 million for iovera°
Net income of $6.8 million, or $0.15 per share (basic and diluted)
Adjusted EBITDA of $53.8 million, or $1.20 per share (basic) and $1.16 per share (diluted)
"We were delighted to end the first quarter of 2022 with record high EXPAREL sales for the month of March, which underscores the significant progress we continue to make despite operational headwinds in the elective surgery market due to COVID and labor-related disruptions," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The successful integration of the Flexion acquisition was evidenced by strong ZILRETTA sales in the first quarter, which we expect to be an important near- and long-term contributor to earnings."

"We look forward to completing our two Phase 3 studies of EXPAREL for lower extremity nerve block and to launching new high-potential registration programs evaluating EXPAREL as a stellate ganglion block for cardiac dysrhythmia. Additionally, as the market moves rapidly toward ultrasound-guided iovera° blocks delivered by pain management specialists, we plan to use our IGOR registry to publish real-world evidence to better support our commercial initiatives," continued Mr. Stack.

Recent Business Highlights

Daryl Gaugler Appointed Chief Operating Officer. Today the company is announcing the appointment of Daryl Gaugler to the position of Chief Operating Officer effective May 4, 2022. Mr. Gaugler has served as the company’s Senior Vice President of Commercial Operations since June 2019. Mr. Gaugler is a seasoned life sciences executive with 30 years of experience in commercial leadership that includes building and directing over 400 commercial teams and designing go-to-market strategies for more than 20 companies. Prior to Pacira, Mr. Gaugler spent over 20 years with the Quintiles Transnational organization (now IQVIA). In his most recent role at Quintiles, President of North America Commercial Solutions, Mr. Gaugler delivered significant revenue and profit growth while leading customer satisfaction and employee engagement within the organization.

New EXPAREL Patents. In March and April 2022, the U.S. Patent and Trademark Office (U.S. PTO) issued Patent Numbers 11,278,494, 11,304,904 and 11,311,486. The ‘494 and ‘486 patents cover composition of EXPAREL while the ‘904 is a product by process patent, each having an expiration date of January 22, 2041. All three patents are now listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalents Evaluations (Orange-Book).

Second Innovation and Training Facility. The company recently launched development plans for its second training facility in Houston, Texas. This 19,000 square-feet state-of-the-art facility will feature an adaptive lecture hall, broadcast studio, and lab space for cadaver and other interactive workshops. Together with the company’s Tampa facility, this second training center will play a core role in developing physician champions and community-based clinicians who want to stay on the forefront of opioid-sparing pain management. The company expects to open the Houston facility before the end of 2022 to host programs for EXPAREL, ZILRETTA and iovera°.
First Quarter 2022 Financial Results

Total revenues were $158.0 million in the first quarter of 2022, versus the $119.0 million reported for the first quarter of 2021.
EXPAREL net product sales were $129.2 million in the first quarter of 2022, versus the $114.7 million reported for the first quarter of 2021.
ZILRETTA net product sales were $23.6 million in the first quarter of 2022. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion Therapeutics, Inc. in November 2021.
First quarter 2022 iovera° net product sales were $3.0 million, versus the $3.3 million reported for the first quarter of 2021.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.6 million in the first quarter of 2022, versus the $0.8 million reported for the first quarter of 2021.
First quarter 2022 royalty and collaborative licensing and milestone revenues were $0.6 million, versus the $0.3 million reported for the first quarter of 2021.
Total operating expenses were $140.6 million in the first quarter of 2022, versus the $99.6 million reported for the first quarter of 2021.
Research and development (R&D) expenses were $21.6 million in the first quarter of 2022, compared to $15.9 million in the first quarter of 2021. R&D expenses included $5.0 million and $4.7 million of product development and manufacturing capacity expansion costs in the first quarters of 2022 and 2021, respectively.
Selling, general and administrative (SG&A) expenses were $64.3 million in the first quarter of 2022, compared to $48.5 million in the first quarter of 2021.
GAAP net income was $6.8 million, or $0.15 per share (basic and diluted), in the first quarter of 2022, compared to $10.4 million, or $0.24 per share (basic) and $0.23 per share (diluted), in the first quarter of 2021.
Non-GAAP net income was $29.9 million, or $0.67 per share (basic) and $0.64 per share (diluted), in the first quarter of 2022, compared to $24.5 million, or $0.56 per share (basic) and $0.53 per share (diluted), in the first quarter of 2021.
Adjusted EBITDA was $53.8 million, or $1.20 per share (basic) and $1.16 per share (diluted) in the first quarter of 2022, compared to $36.2 million, or $0.83 per share (basic) and $0.79 per share (diluted) in the first quarter of 2021.
Pacira ended the first quarter of 2022 with cash, cash equivalents and short-term available-for-sale investments ("cash") of $452.2 million. Cash provided by operations was $30.8 million in the first quarter of 2022, compared to $12.1 million in the first quarter of 2021.
Pacira had 44.9 million basic and 46.4 million diluted weighted average shares of common stock outstanding in the first quarter of 2022.
See "Non-GAAP Financial Information" below.

Financial Guidance

The company’s product sales continue to be impacted by COVID-19, which has caused significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market, the company is currently not providing revenue or gross margin guidance. To provide greater transparency, Pacira is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° until it has gained enough visibility around the impacts of COVID-19. Pacira is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter.

Today the company is reiterating its full-year 2022 operating expense guidance as follows:

Non-GAAP R&D expense of $75 million to $85 million;
Non-GAAP SG&A expense of $220 million to $230 million; and
Stock-based compensation of $40 million to $45 million.
See "Non-GAAP Financial Information" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, May 4, 2022, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 4063578. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 4063578. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per common share, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, adjusted EBITDA (as defined below) and adjusted EBITDA per share, because these non-GAAP financial measures exclude the impact of items that management believes affect comparability or underlying business trends.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2022 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures.

On May 4, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, reported an upcoming oral presentation on novel oncolytic adenovirus VCN-11 at the 25th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper), to be held virtually and in-person from May 16-19, 2022 in Washington, D.C (Press release, Synthetic Biologics, MAY 4, 2022, View Source [SID1234613552]).

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The oral presentation will feature Ramon Alemany, Ph.D., Head of the Immunotherapy and Virotherapy Group at the Translational Research Laboratory of the Institut Catala d’Oncologia (ICO) and Institut de Investigacio Biomedica de Bellvitage (IDIBELL).

"We are excited to present new data on VCN-11, which should further position us at the forefront of oncolytic virus development," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "VCN-11 is a next-generation adenovirus that is genetically modified to express hyaluronidase and degrade the protective tumor stroma barrier. It is also engineered to incorporate a proprietary albumin binding domain in the virus’ outer shell, which is intended to improve systemic delivery by enabling the virus to coat itself in albumin and thereby evade neutralizing antibodies (NAbs). The presentation at ASGCT (Free ASGCT Whitepaper) will include preclinical results showcasing the potential of VCN-11 to balance safety, with no major toxicities observed, and effectively target tumors after intravenous re-administration, even in the presence of high level NAbs. We look forward to building upon our foundation of compelling proof-of-mechanism data and continuing to advance our oncolytic adenovirus (OV) program through clinical development."

The full abstract (#98) is accessible on the ASGCT (Free ASGCT Whitepaper) conference portal and details for the oral presentation are included below.

Title: Oncolytic Adenovirus with Hyaluronidase Activity That Evades Neutralizing Antibodies and Allows Re-Administration: VCN-11
Session Title: Cancer-Oncolytic Viruses
Presenter: Ramon Alemany, Ph.D.
Presentation Date and Time: Monday, May 16, 2022, 5:15 – 5:30 p.m. ET

On May 4, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HM43239, an oral, myeloid kinome inhibitor, for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation (Press release, Aptose Biosciences, MAY 4, 2022, View Source [SID1234613551]). Currently, an international Phase 1/2 clinical trial is ongoing for HM43239 in the R/R AML patient population. HM43239 received orphan drug designation from the FDA for treatment of acute myeloid leukemia in 2018.

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"Fast Track status acknowledges HM43239’s potential to fill an unmet need for AML patient populations and supports our efforts as we advance it towards a potential registration study," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "HM43239, which potently inhibits all tested forms of FLT3 and the SYK and JAK driven pathways, already has delivered complete remissions in a broad diversity of relapsed or refractory AML patients in an ongoing Phase 1/2 clinical trial, including patients with prior failure of other FLT3 inhibitor agents. Fast Track designation will help facilitate the drug’s development."

About Fast Track Designation

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the sponsor is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. Visit the FDA website for more information.

About HM43239

HM43239 is a potent oral genotype-agnostic small molecule inhibitor of a constellation of kinases operative in myeloid malignancies and known to be involved in tumor proliferation, resistance to therapy, and differentiation. Currently being developed for the treatment of patients with acute myeloid leukemia (AML), HM43239 is a potent inhibitor of FLT3, SYK, mutant forms of cKIT, JAK1/2, and other kinases. Regarding FLT3, HM43239 is highly active in vivo against FLT3 internal tandem duplication (ITD), as well as resistance-conferring D835 and gatekeeper (F691) tyrosine kinase domain (TKD) mutations. In vivo murine xenograft models suggest superior antitumor activity and favorable tolerability relative to established kinase inhibitor in AML, including gilteritinib (FLT3 inhibitor) and entospletinib (SYK inhibitor). Additionally, in vivo xenograft models suggest synergy with inhibitors of DNMT, BCL-2, and other key therapeutic targets, highlighting the combinatorial optionality of HM43239 in AML. In an ongoing international Phase 1/2 clinical trial, HM43239 has delivered complete remissions in a diversity of relapsed or refractory AML patients and continues to be a well-tolerated oral agent.

On May 4, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) and SOLTI-Innovative Cancer Research reported new clinical biomarker data demonstrating pelareorep’s immunotherapeutic effects, synergy with checkpoint inhibition, and potential to improve the outlook for patients with HR+/HER2- breast cancer (Press release, Oncolytics Biotech, MAY 4, 2022, View Source [SID1234613550]). The data, which are featured in a poster presentation at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Meeting, are from cohorts 1 and 2 of the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.

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Patients in AWARE-1’s first two cohorts were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1), or with (cohort 2), the PD-L1 checkpoint inhibitor atezolizumab approximately 21 days prior to the surgical resection of their tumors. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with HR+/HER2- disease, the breast cancer subtype that Oncolytics intends to examine in a future registrational study. Previously reported results showed AWARE-1 met its primary translational endpoint, with cohort 2 achieving the pre-specified success criteria for treatment-induced increases in CelTIL score (link to the PR). CelTIL score is a metric for tumor inflammation and cellularity and is associated with improved clinical outcomes in breast cancer patients.

"The latest data from AWARE-1 further demonstrate pelareorep’s potential to improve clinical outcomes in breast cancer patients through its ability to activate T cells and remodel the tumor microenvironment," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "Notably, pelareorep treatment increased markers of tumor cell death and, perhaps even more impressive, 100% of evaluable pelareorep-treated patients had a favorable Risk of Recurrence Score (ROR-S) compared to 55% at baseline. Together, these latest AWARE-1 results further establish pelareorep’s ability to attack tumors through multiple mechanisms."

Key data and conclusions from the ESMO (Free ESMO Whitepaper) Breast Cancer poster include:

Gene expression analyses showed 100% of evaluable patients had a Risk of Recurrence Score (ROR-S) classified as "low" at surgery vs. 55% with a "low" ROR-S at baseline (information pertaining to prognostic testing of gene signature assays in breast cancer can be found by clicking here)
Treatment with pelareorep with (cohort 2) or without (cohort1) atezolizumab led to the conversion of tumors from the more aggressive luminal B to the luminal A subtype, which is associated with improved clinical outcomes
100% of evaluable cohort 2 tumors were luminal A at surgery (21 days post-treatment) vs. 70% at baseline (pre-treatment)
70% of evaluable cohort 1 patients had luminal A tumors at surgery vs. 40% at baseline
Pooled analysis of tumors from cohorts 1 and 2 shows a statistically significant 4-fold post-treatment increase in the average expression of caspase 3, which is a marker of apoptotic cell death
Pooled analysis across cohorts 1 and 2 shows statistically significant increases in markers of T cell activation and no significant changes in markers of T cell exhaustion from baseline to surgery
Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "AWARE-1’s results continue to exceed our expectations. With each new dataset, we gain additional clarity on how pelareorep’s immunologic mechanism of action synergistically combines with checkpoint inhibition. The study has also identified changes in blood T cell populations as a potential biomarker to predict patient response. We are now working to confirm these promising findings with efficacy data and additional biomarker analyses from our ongoing BRACELET-1 trial. If positive, we expect BRACELET-1’s results to inform the design of a registrational study in HR+/HER2- breast cancer and validate our broader strategy of developing pelareorep in combination with leading anti-cancer agents."

BRACELET-1 is a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. The trial includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep, and paclitaxel plus pelareorep in combination with a checkpoint inhibitor. Top-line data from the trial are expected in Q4 2022.

The poster, entitled, The oncolytic virus pelareorep primes the tumor microenvironment for checkpoint blockade therapy in early breast cancer patients – Results from AWARE-1 study, is being presented during the "Biomarkers and translational research and precision medicine" session of the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting. Following the conclusion of the meeting, the poster will be available on the Posters & Publications page of Oncolytics’ website (LINK).

About AWARE-1

AWARE-1 was an open-label window-of-opportunity study in early-stage breast cancer. The study combined pelareorep, without or with atezolizumab, and the standard of care therapy according to breast cancer subtype. Tumor tissue was collected from patients as part of their initial breast cancer diagnosis, again on day three following initial treatment, and finally at three weeks following treatment, on the day their tumor is surgically resected. Key objectives of the study were to confirm that pelareorep is acting as a novel immunotherapy, to evaluate potential synergy between pelareorep and checkpoint blockade, and to collect biomarker data. The primary endpoint of the translational study was overall CelTIL score (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study included safety and tumor and blood-based biomarkers.