On May 13, 2022 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its first quarter ended March 31, 2022 (Press release, HCW Biologics, MAY 13, 2022, View Source [SID1234614522]).

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"We continue to successfully execute our clinical development strategy which is based on our unique approach toward inflammaging," stated Hing C. Wong, Founder and CEO of HCW Biologics Inc. "HCW Biologics is developing immunotherapeutics that do not treat a single indication or symptom. Our approach is to treat a patient systemically to remove the underlying problems causing a condition."

Dr. Wong continued, "Our plan is to use difficult-to-treat cancer indications as the gateway for clinical development of our lead product candidate, HCW9218. In preclinical studies, we have demonstrated that HCW9218 can effectively reduce therapy-induced cancer and normal tissue cellular senescence to augment the anti-tumor activities of chemotherapies and alleviate their side effects. In addition, HCW9218 has been shown to significantly enhance anti-tumor activity of immune checkpoint therapies in a preclinical setting."

Dr. Wong further stated, "We believe that HCW9218 also has potential as a treatment for a broad range of age-related pathologies beyond cancer, through our discovery that HCW9218 can reduce accumulated senescent cells due to the naturally aging process or metabolic dysfunction, leading to the improvement of health span of experimental animals."

Business Highlights:

At the 105th Annual Meeting of the American Association of Immunologists held on May 6 -10, 2022, HCW Biologics showcased two novel groups of fusion molecules invented with the Company’s proprietary and versatile TOBI discovery platform. Two posters were presented which are available on the Company’s website:

A "kick and expand" strategy to generate large numbers of CIML NK cells for adoptive cell therapy for the treatment of cancer using novel fusion proteins HCW9201 and HCW9206.

Robust human regulatory T cell expansion with fusion proteins HCW9302 and HCW9213 circumvents need for magnetic-bead or feeder cell approaches for adoptive cell therapy.

On April 19, 2022, Dr. Hing Wong presented, "Bifunctional Immunotherapeutic HCW9218 for Cancer and Inflammaging," at the Third Annual International Conference on Cell and Experimental Biology. Dr. Wong presented preclinical data for the first time that showed results of the Company’s investigational work related to the treatment of inflammaging indications in naturally-aged mice. The Company believes these results demonstrate the potential of HCW9218 to fundamentally change the treatment of a broad range of diseases and conditions associated with aging, even aging itself, by enhancing health span that has been diminished with aging.

First Quarter 2022 Financial Results:

Cash and cash equivalents: On March 31, 2022, the Company’s cash balance was $18.1 million, short-term investments were $17.0 million and long-term investments were $9.8 million. Investments are all U.S. Treasury bills or notes. The Company estimates that the current cash balance is sufficient to fund operations through the end of 2023.

Revenues: Revenues were $3.1 million for the three-month period ended March 31, 2022, and there were no revenues in the three-month period ended March 31, 2021. Revenues were derived from the sale of clinical development material to our licensee, Wugen.

Research and development (R&D) expenses: R&D expenses were $1.8 million for the three-month period ended March 31, 2022, as compared to $2.3 million for the three-month period ended March 31, 2021. The 22% decrease in R&D expenses was driven primarily by a decrease in manufacturing and materials expenses and preclinical expenses.

General and administrative expenses (G&A): G&A expenses were $1.9 million for the three-month period ended March 31, 2022, as compared to $1.1 million for the three-month period ended March 31, 2021. The 73% increase reflects higher salaries, benefits and related expenses as a result of stock-based compensation expense associated with an equity award to the Company’s CEO upon completion of the Company’s IPO and an increase for Board compensation under our non-employee director compensation program, with a partial offset resulting from a decrease in performance-related bonuses.

Net loss: Net loss was $2.1 million for the three-month period ended March 31, 2022, compared to $2.8 million for the three-month period ended March 31, 2021.

On May 13, 2022 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), a diversified commercial-stage medical technology company, and its majority-owned subsidiary Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid"), a commercial-stage cancer prevention medical diagnostics company, reported that PAVmed and Lucid Chairman & Chief Executive Officer Lishan Aklog, M.D. was selected as one of the Top 50 Healthcare Technology CEOs of 2022 by The Healthcare Technology Report (Press release, PAVmed, MAY 13, 2022, View Source [SID1234614538]).

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"I am so fortunate to work with a rapidly growing team of the best and brightest in the industry, who all share a passion to serve patients through technology and to drive long-term shareholder value through strategic execution."

"I would like to thank The Healthcare Technology Report for this honor," said Dr. Aklog. "I am so fortunate to work with a rapidly growing team of the best and brightest in the industry, who all share a passion to serve patients through technology and to drive long-term shareholder value through strategic execution."

The Healthcare Technology Report described this year’s awardees as "some of the most cultivated, intelligent executives in the healthcare and technology industry." Their "leadership and innovation remain crucial in the development of industry leading medical devices, next generation software platforms, cutting-edge drugs and therapeutics, and advanced diagnostics, among other technologies" all while making "momentous contributions and improvements across the globe."

The editors carefully evaluated hundreds of CEOs across the fields of healthcare, medical devices, biotech, healthcare software, and more. The list includes CEOs from industry leaders such as Medtronic, Edwards Lifesciences and ResMed. Like Dr. Aklog, many of the recipients are founders or co-founders of their organizations.

About Lishan Aklog, M.D.
Dr. Lishan Aklog is Chairman & CEO of PAVmed Inc. (Nasdaq: PAVM), a diversified, commercial-stage medical technology company which he co-founded, and its majority-owned subsidiary Lucid Diagnostics Inc., a cancer prevention medical diagnostics company (Nasdaq: LUCD). He also serves on the board of the leading medtech industry group, AdvaMed, and as an independent public company director. He previously co-founded a medtech holding company which founded four medical device companies and led one of its portfolio companies which commercialized one of his life-saving inventions, AngioVac. Dr. Aklog has consulted for leading medtech companies and is an inventor on dozens of patents. The Healthcare Technology Report previously recognized him as a Top Healthcare Technology CEO of 2021. Prior to entering the life sciences industry as an entrepreneur and executive, Dr. Aklog had a distinguished career as an innovator in cardiac surgery, serving on the faculty of leading academic medical centers including Harvard Medical School and Mount Sinai Medical Center, and in professional society leadership positions. He was recognized as an America’s Top Doctor for over a decade. He received his undergraduate degree in Physics, magna cum laude, and M.D., cum laude, from Harvard University. He completed his training at Harvard teaching hospitals and leading medical centers in London and Paris.

On May 13, 2022 UroGen Pharma Ltd. (Nasdaq: URGN) reported that highlighted four presentations of interest featuring data on JELMYTO (mitomycin) for pyelocalyceal solution for patients with low-grade upper tract urothelial cancer (LG-UTUC) and investigational agent UGN-102 (mitomycin) for intravesical solution in Phase 3 clinical development as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) at the upcoming 2022 American Urological Association (AUA) Annual Meeting, May 13-16 in New Orleans, Louisiana (Press release, UroGen Pharma, MAY 13, 2022, View Source [SID1234614523]). The presentations will be published in the June 2022 issue of The Journal of Urology and will be accessible via the AUA website.

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Details on AUA Presentations:

Podium Presentation
Abstract #: PD26-08
Session: Low-grade urothelial carcinoma recurs at a tempo that naturally accelerates from Adagio to Allegro
Presenter: Alex Sankin, M.D., Associate Professor Department of Urology, Albert Einstein College of Medicine
Date and Time: Saturday, May 14, 2022 at 2:10-2:20 PM CT
Location: Room 252

ICU Theater
Session: Chemoablation as primary treatment: Transforming the paradigm for low grade UTUC with JELMYTO
Presenter: Jennifer Linehan, M.D. Associate Professor of Urology and Urologic Oncology at the Saint John’s Cancer Institute
Date and Time: Sunday, May 15, 2022 at 12:00-1:00 PM CT
Location: S&T Hall: Booth 1043

Moderated Poster
Abstract #: MP54-06
Session: Longitudinal Health-Related Quality of Life Outcomes in Adults with Non-Muscle-Invasive Bladder Cancer Receiving a Chemoablative Gel as a Primary Treatment (Optima II: Phase 2b, single arm, open-label trial)
Presenter: Angela Smith, M.D., M.S. Associate Professor at the University of North Carolina (UNC) Department of Urology in Chapel Hill, North Carolina
Date and Time: Monday, May 16, 2022 at 8:45-10:00 AM CT
Location: Room 228

Podium Presentation
Abstract #: PD58-06
Session: Antegrade Administration of Reverse Thermal Mitomycin Gel for Primary Chemoablation of Upper Tract Urothelial Carcinoma via Percutaneous Nephrostomy Tube: a Multi-Institutional Real-World Experience
Presenter: Kyle Rose, M.D., Urologic Oncology Fellow at Moffitt Cancer Center in Tampa, Fla.
Date and Time: Monday, May 16, 2022 at 1:50-2:00 PM CT
Location: Room 252

UroGen will be hosting Booth #837 at the Ernest N. Morial Convention Center during AUA 2022.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG UTUC in adults. It is recommended for primary treatment of biopsy-proven LG UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.

Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.

are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

On May 13, 2022 Glycostem Therapeutics B.V., a leading clinical-stage company focused on the development of therapeutic allogeneic off-the-shelf Natural Killer (NK) cells, reported that an abstract on further findings of patients treated in its phase I/IIa WiNK trial have been accepted and will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, which will take place 9th – 12th June 2022 in Vienna, Austria (Press release, Glycostem Therapeutics, MAY 13, 2022, View Source [SID1234614540]). oNKord is the company’s first-generation off-the-shelf allogeneic NK cell therapy under clinical development. Glycostem is furthermore developing a range of CAR-NK, combination therapy and TCR-NK products in-house.

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"Achieving measurable residual disease (MRD) negativity is associated with longer-term survival in patients with AML. Our initial clinical data shows that all patients in the first dose cohort reached some level of MRD negativity with an excellent safety profile thus far," said Dr. Kai Pinkernell, CMO of Glycostem. "We are looking forward to the results on the following, increased dose levels, which we expect to further support the safety and activity of oNKord as shown in the early follow up."

The EHA (Free EHA Whitepaper) abstract is now available at View Source as EHA (Free EHA Whitepaper)-3555 with the title:

EARLY SAFETY AND CLINICAL COURSE OF PATIENTS WITH ACUTE MYELOID LEUKEMIA AND MEASURABLERESIDUAL DISEASE RECEIVING GTA002, AN OFF-THE-SHELF, EX VIVO-CULTURED ALLOGENEIC NK CELL PREPARATION

Glycostem will present the poster on Friday, 10th June 2022 at 16:30 – 17:45 CEST.

On May 13, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the quarter ended March 31, 2022 and provided a corporate update (Press release, Tempest Therapeutics, MAY 13, 2022, View Source [SID1234614524]).

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"The team continued to execute well throughout the first quarter of this year, enabling us to present the first clinical data from a Tempest program at the ASCO (Free ASCO Whitepaper) Annual Meeting in June," said Stephen R. Brady, chief executive officer of Tempest. "We look forward to the upcoming oral presentation, which will highlight the clinical profile and responses observed in the monotherapy and combination Phase 1 study of TPST-1120, our novel PPARa antagonist."

________________________
1 If approved by the FDA

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) completed enrollment in the Phase 1 monotherapy and combination dose escalation arms; (ii) announced that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) accepted for an oral presentation at its 2022 Annual Meeting an abstract containing the TPST-1120 Phase 1 monotherapy and combination data; and (iii) continued enrollment in first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating both monotherapy and combination (with anti-PD-1 checkpoint inhibitor, pembrolizumab) dose and schedule optimization arms, towards establishing an RP2D; (ii) presented preclinical data further differentiating TPST-1495 from other approaches targeting the prostaglandin E2 (PGE2) pathway at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting; and (ii) announced that ASCO (Free ASCO Whitepaper) accepted for a poster presentation a "trials in progress" for the ongoing TPST-1495 Phase 1 clinical monotherapy and combination therapy clinical trial.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): presented the first data with proprietary targeted molecules demonstrating therapeutic benefit in tumor-bearing mice at the AACR (Free AACR Whitepaper) 2022 Annual Meeting.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): (i) first presentation of clinical data from a Tempest program at the oral presentation of the Phase 1 monotherapy and combination data at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting; and (ii) objective response data from the first 40 HCC patients in the first-line randomized study expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) presentation of "trial in progress" poster at ASCO (Free ASCO Whitepaper) 2022 Annual Meeting; and (iii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the second half of 2022.
PIPE Financing

On April 27, we announced a $15 million private investment in public equity (PIPE) financing to EcoR1 Capital, LLC and Versant Venture Capital.
Financial Results

First Quarter

Tempest ended the first quarter of 2022 with $45.8 million in cash and cash equivalents, compared to $51.8 million at December 31, 2021. The decrease was primarily due to cash used in operations of $7.1 million offset by proceeds from sales under our ATM program of $1.4 million. Cash balance does not reflect $15 million raised in April from PIPE financing.
Net cash used in operations for the quarter ended March 31, 2022 was $7.1 million compared to $6.3 million for the same period in 2021.
Net loss and net loss per share for the quarter ended March 31, 2022 were $8.5 million and $1.18, respectively, compared to $5.4 million and $10.55, respectively, for the first quarter of 2021.
Research and development expenses for the first quarter of 2022 were $5.1 million compared to $3.6 million for the same period in 2021. The $1.5 million increase was primarily attributable to expanded research and development efforts and increased fees for consulting services and compensation expenses.
For the three months ended March 31, 2022, general and administrative expenses were $3.0 million compared to $1.5 million for the same period in 2021. The increase of $1.5 million was primarily due to higher professional and consulting fees, insurance, and compensation expenses.