Aitisi Biotechnology (Shanghai) Co. Ltd.

– Reported Encouraging Updated Data in Q2 from Two Clinical Trials of Galinpepimut-S (GPS) in Combination with Checkpoint Inhibitors– – Provides Clinical Update for GFH009 Program – – Cash Position of $27.0 million as of June 30, 2022 – – To Host Virtual Investor Symposium on GPS on September 15, 2022 – NEW YORK, Aug. 11, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today provided a business update and reported its financial results for the quarter ended June 30, 2022. “During the second quarter of 2022, SELLAS continued to progress our pipeline of treatment options to potentially improve and prolong the lives of patients battling cancer, with our lead asset, GPS, achieving several important milestones,” said Angelos Stergiou, M.D., Sc.D. h.c., President and Chief Executive Officer of SELLAS. “We reported clinical benefits seen in preliminary data from our Phase 1/2 clinical trial of GPS in combination with the checkpoint inhibitor KEYTRUDA® in patients battling WT1+ advanced ovarian cancer as well as encouraging updated clinical data from a Phase 1 investigator-sponsored clinical trial of GPS in combination with another checkpoint inhibitor, OPDIVO®, in patients with malignant pleural mesothelioma (MPM). In our Phase 3 REGAL study, we continued enrolling patients and activating additional sites across the United States, Europe, and Asia.” “Additionally, we were pleased to report encouraging preliminary results for our GFH009 program, a novel and highly selective, potentially first and best in class CDK9 inhibitor. Clinical data from the ongoing Phase 1 dose-escalating clinical trial of GFH009 in the United States and China in advanced relapsed and refractory lymphoma and acute myeloid leukemia (AML) shows no dose-limiting toxicities at all dose levels studied to date, while also demonstrating early indications of biological efficacy in assessable patients at multiple dose levels. We are excited by these preliminary results as well as the data from preclinical in vitro studies showing significant inhibition of cancer cell growth in four cell lines announced earlier this week, and we look forward to continuing to study GFH009 to further explore its anticancer effects,” concluded Dr. Stergiou. Pipeline Updates: Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting peptide immunotherapeutic Phase 1/2 Study in Combination with KEYTRUDA (pembrolizumab): In May 2022, SELLAS announced top-line clinical data showing clinical benefit from its Phase 1/2 trial of GPS in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in patients diagnosed with WT1+ relapsed or refractory platinum resistant advanced metastatic ovarian cancer.Phase 1 Study in Combination with OPDIVO (nivolumab): In June 2022, SELLAS announced encouraging updated clinical data from a Phase 1 investigator-sponsored clinical trial of GPS in combination with the checkpoint inhibitor OPDIVO in patients with MPM who were either refractory to or relapsed after at least one line of the standard of care therapy.Phase 3 REGAL Study: During the second quarter of 2022, SELLAS continued enrolling patients and activated additional sites in Poland, Greece and Hungary for its registrational global Phase 3 REGAL clinical trial in patients with AML. Enrollment for the study is scheduled to be completed in early in 2023, with an interim analysis planned to occur by the end of the first half of 2023. This timeline is based on current assumptions related to COVID-19 and its impact on the operations of clinical sites, as well as the duration of the pandemic. Because the interim analysis is event driven, it may become available at a different time than currently expected. The Company plans to activate additional sites in the United States and several countries in Europe and Asia throughout the remainder of 2022, including Serbia, Spain, Italy, Poland, Turkey and Taiwan. GFH009: small molecule, highly selective CDK9 inhibitor Preclinical In Vitro Studies in Solid Cancer and AML Cell Lines: In early August, the Company announced results from its preclinical in vitro studies in solid cancer and AML cell lines. The data shows that GFH009 demonstrated significant anti-tumor effects in all four selected cell lines with cancer cell growth inhibited by 90 to 100 percent in three out of the four cell lines and by more than 50 percent in the fourth cell line.Clinical Update on Phase 1 Trial: As of August 1, 2022, enrollment at all originally planned dose levels, administered twice a week, in the AML group (30 mg) and at the 22.5 mg dose level for the lymphoma group was completed. Among the 30 patients evaluable for safety and efficacy, no dose limiting toxicities have been observed. Four lymphoma patients (three at 4.5 mg and one at 9 mg) achieved stable disease (SD). One patient with peripheral T cell lymphoma treated at the 9 mg dose had 62% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) based on computed tomography (CT). Two AML patients, one treated at the 9 mg dose level and one treated at the 15 mg dose level, had decreases of bone marrow blasts equal to or greater than 50%.Phase 1 Clinical Trial Protocol Amendment: The Company announced in July that a second, once-a-week dose cohort has been added in its ongoing Phase 1 clinical trial in both the United States and China to study once-a-week administration starting at the higher dose level of 30 mg which will provide additional data for the safety and efficacy profile for GFH009. Corporate Updates: Underwritten Public Offering: On April 5, 2022, the Company closed an underwritten public offering providing gross proceeds of $25.0 million, before deducting underwriting discounts and commissions and offering expenses.Milestone Payment: The Company received a $1.0 million milestone payment in May 2022 for the approval by China’s National Medical Products Administration (NMPA) of an IND application to initiate the first clinical trial in China for GPS. Financial Results for the Second Quarter 2022: Licensing revenue: There was no licensing revenue for the second quarter of 2022 and $1.0 million for the first half of 2022, which related to China’s NMPA approval of an IND application by 3D Medicines. This compares to $1.9 million for the second quarter of 2021 and $7.6 million for the first half of 2021. R&D Expenses: Research and development expenses for the second quarter of 2022 were $5.5 million, compared to $3.5 million for the same period in 2021. Research and development expenses were $10.1 million for the first half of 2022, compared to $7.7 million for the same period in 2021. The increase was primarily due to an increase in clinical trial expenses related to the Company’s ongoing Phase 3 REGAL clinical trial of GPS in AML patients, a ramp up of the manufacture of clinical trial materials and registration batches of GPS, and personnel related expenses due to increased headcount. Acquired In-Process Research and Development: There was no acquired in-process research and development for the second quarter of 2022. Acquired in-process research and development was $10.0 million for the first half of 2022, resulting from the in-licensing of GFH009. There was no acquired in-process research and development during the same periods in 2021. G&A Expenses: General and administrative expenses for the second quarter of 2022 were $3.1 million, as compared to $2.8 million for the same period in 2021. The increase was primarily due to personnel related expenses due to increased headcount. General and administrative expenses were $6.1 million for the first half of 2022, compared to $6.4 million for the same period in 2021. The decrease was primarily due to a decrease in amortization expense associated with the capitalized contract acquisition costs of the 3D Medicines license agreement and a decrease in professional service fees, partially offset by an increase in personnel related expenses due to increased headcount. Net Loss: Net loss was $8.4 million for the second quarter of 2022, or a basic and diluted loss per share of $0.41, compared to a net loss of $4.6 million for the same period in 2021, or a basic and diluted loss per share of $0.30. Net loss was $25.2 million for the first half of 2022, or a basic and diluted loss per share of $1.39, compared to a net loss of $7.0 million for the same period in 2021, or a basic and diluted loss per share of $0.47. Cash Position: As of June 30, 2022, cash and cash equivalents totaled approximately $27.0 million. Upcoming Investor Symposium The Company will host a virtual investor symposium on Thursday, September 15, 2022, from 1:00 p.m. to 2:00 p.m. ET. The event will focus on the Company’s lead clinical asset, GPS, including the potential commercial opportunity for GPS in AML patients. Event:Galinpepimut-S Update CallDate:Thursday, September 15, 2022Time:1:00 p.m. Eastern TimeLive Call:+1-877-407-9716 (U.S. Toll Free) or +1-201-493-6779 (International)Webcast:https://viavid.webcasts.com/starthere.jsp?ei=1550371&tp_key=70b7ae2fef For interested individuals unable to join the conference call, a replay will be available through September 29, 2022, at +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International). Participants must use the following code to access the replay of the call: 13730135. An archived version of the webcast will also be available on SELLAS’ Investor Relations site: https://www.sellaslifesciences.com/investors/ About SELLAS Life Sciences Group, Inc. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing GFH009, a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit www.sellaslifesciences.com. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, and is not a trademark of SELLAS. OPDIVO® is a registered trademark of Bristol Myers Squibb, and is not a trademark of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products. Forward-Looking StatementsThis press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the clinical development of GPS and GFH009 for various cancer indications, including the timing of commencement and completion of, and data from, clinical trials therefor, the potential for GPS and GFH009 as drug development candidates for various cancer indications, alone and in combination with other therapeutic agents and the timing for the completion of enrollment for the GPS REGAL Phase 3 clinical trial. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the COVID-19 pandemic and its impact on the Company’s clinical plans, risks and uncertainties associated with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 31, 2022 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. Investor ContactAllison SossKCSA Strategic CommunicationsEmail: SELLAS@kcsa.com Phone: 212.896.1267 Media ContactRaquel Cona / Michaela FawcettKCSA Strategic CommunicationsEmail: SELLAS@kcsa.com Phone: 212.896.1276 SELLAS LIFE SCIENCES GROUP, INC.CONSOLIDATED STATEMENTS OF OPERATIONS(Amounts in thousands, except share and per share data)(Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Licensing revenue $— $1,900 $1,000 $7,600 Operating expenses: Cost of licensing revenue — 100 100 200 Research and development 5,529 3,456 10,140 7,740 Acquired in-process research and development — — 10,000 — General and administrative 3,094 2,797 6,118 6,358 Total operating expenses 8,623 6,353 26,358 14,298 Operating loss (8,623) (4,453) (25,358) (6,698)Non-operating income (expense), net: Change in fair value of warrant liability 48 (28) 37 (59)Change in fair value of contingent consideration 115 (134) 115 (263)Interest income 46 2 48 4 Total non-operating income (expense), net 209 (160) 200 (318)Net loss $(8,414) $(4,613) $(25,158) $(7,016) Per share information: Net loss per common share, basic and diluted $(0.41) $(0.30) $(1.39) $(0.47)Weighted-average common shares outstanding, basic and diluted 20,286,624 15,270,288 18,104,176 15,074,887 SELLAS LIFE SCIENCES GROUP, INC.CONSOLIDATED BALANCE SHEETS(Amounts in thousands, except share and per share data)(Unaudited) June 30, 2022 December 31, 2021 ASSETS Current assets: Cash and cash equivalents$26,987 $21,355 Restricted cash and cash equivalents 100 100 Prepaid expenses and other current assets 1,650 1,589 Total current assets 28,737 23,044 Operating lease right-of-use assets 1,045 723 Goodwill 1,914 1,914 Deposits and other assets 514 594 Total assets$32,210 $26,275 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$3,339 $2,144 Accrued expenses and other current liabilities 3,006 2,640 Operating lease liabilities 341 198 Acquired in-process research and development payable 5,500 — Total current liabilities 12,186 4,982 Operating lease liabilities, non-current 783 610 Warrant liability 3 40 Contingent consideration 181 296 Total liabilities 13,153 5,928 Commitments and contingencies (Note 7) Stockholders’ equity: Preferred stock, $0.0001 par value; 5,000,000 shares authorized; Series A convertible preferred stock, 17,500 shares designated; no shares issued and outstanding at June 30, 2022 and December 31, 2021 — — Common stock, $0.0001 par value; 350,000,000 shares authorized, 20,551,918 and 15,895,637 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively 2 2 Additional paid-in capital 182,816 158,948 Accumulated deficit (163,761) (138,603) Total stockholders’ equity 19,057 20,347 Total liabilities and stockholders’ equity$32,210 $26,275

3D Vaccine Patch/Courtesy of University of North Carolina School of Medicine. A vaccine patch that generates an immune response ten times greater than that of a traditional intramuscular injection has been developed by researchers at the University of North Carolina at Chapel Hill and Stanford University. Its T-cell and antigen-specific antibody response is even greater. That’s 50-fold higher than with subcutaneous injections. Consequently, the patch is not only painless, it requires less vaccine to generate the same or greater effects. This 3D-printed patch enhanced vaccine retention in the skin and increased immune cell activation in the lymph nodes. That was evidenced by higher total levels of immunoglobulin G (IgG), more balanced IgG1/IgG2a and more functional cytotoxic CD8+ T cells and CD4+T cells secreting T helper type 1 (TH1) cytokines. The patch consists of 700 µm PEG microneedles 3D-printed on a 10x10mm polymer patch. The needles were coated with vaccine and then the patch was placed on the skin. The result is a painless, less invasive vaccine delivery method that can be administered by patients themselves without the need for medical personnel. Details appeared recently in Proceedings of the National Academy of Scientists. As lead author Shaomin Tian, a researcher in the department of microbiology and immunology in the UNC School of Medicine, told BioSpace, there are two key mechanisms that make the vaccine patch more effective than standard intramuscular injections. First, she said, “skin is the first line of bodily protection. The density of cells that sample invading pathogens is 1,000 times higher (in skin) than those found in the muscles. Therefore, intradermal vaccination via microneedles inherently targets the vaccines to the rich immune cell populations in the skin and (thus) helps mount faster and stronger immunity.” Furthermore, Tian continued, “the dry solid film microneedle vaccines are specially formulated with highly viscous components. Upon vaccine administration, an antigen depot can be formed that supports sustained antigen exposure to immune cells, and therefore, helps induce stronger immune responses.” This delivery method can be adjusted to deliver many different vaccines or biologics (including mRNA vaccines) for COVID-19, seasonal influenza, measles, hepatitis and other conditions. Importantly for global distribution, microneedle formulations are stored in a dried form, so there is no need for vaccine reconstitution, or possibly, for cooling during shipping and storage. The researchers are collaborating with VLP Therapeutics to formulate RNA-based microneedle patch vaccines. “Custom formulation of various types of vaccines – including mRNA – on microneedle patches requires upfront investigation time,” Tian pointed out. “We anticipate that once standardized formulations are established for each class of vaccines (which we are now working on), this will be a quick process, especially for already approved vaccines.” The next step will be to test those microneedle formulations and the patch in non-human primates. Ultimately, Tian said, “I envision a normal regulatory review process, including evaluation of the vaccine safety and efficacy/protection, will still be required for microneedle patch-based mRNA vaccine formulations.” The other key challenge to commercialization is manufacturing the patches in massive quantities under GMP conditions. “This could be addressed relatively easily by establishing clean manufacturing facilities that house large numbers of 3D printers for mass fabrication,” she suggested. The anticipated benefits are likely to outweigh any challenges, though. Design flexibility is one of the key benefits of 3D printing vaccine patches. The 3D printing process enables the microneedles to be sharper – and thus yield more reproducible results – than is possible when using the traditional master templates and molds used to make microneedles commercially today. This new method also enables needles with different shapes to be included on the same patch to avoid what the authors called a “bed of nails effect.” This novel 3D printing process uses continuous liquid interface production (CLIP) technology developed by study author Joseph M. DeSimone, professor of translational medicine and chemical engineering at Stanford University and professor emeritus at UNC-Chapel Hill. CLIP technology created faceted microneedles with greater surface area than the smooth square pyramidal design. This difference allowed the needles to carry more vaccine than traditional microneedles – 27.6 μg vs 20.3 μg ovalbumin, for 36% higher loading. Additionally, CLIP “allows the direct fabrication and rapid screening of a multitude of microneedle properties (such as geometry, composition and density) in an iterative design process, with the need to consider the parameters associated with mold filling or the limitations of needle geometries that cannot be molded,” the authors wrote. Because microneedle patch vaccinations are painless when compared to traditional hypodermic needle injections, “this would be an ideal vaccination approach for children, the elderly and those who may have needle phobia. It thus could help enhance the vaccination rate,” Tian speculated.

Photo credit, all images: Arevo On May 26, additive manufacturing specialist Arevo (Milpitas, Calif., U.S.) launches Scotsman, a new electric scooter brand whose flagship product is a custom 3D-printed, carbon fiber/thermoplastic composite electric kickscooter. Scotsman’s entire unibody construction — frame, handlebar, stem and foldable baseboard — are 3D-printed with aerospace-grade Hexcel (Stamford, Conn., U.S.) carbon fiber and polyamide (PA), constructed seamlessly without joints or glue. Designed for impact resistance and durability, the composite frame is said to weigh 15-20 kilograms (33-44 pounds) plus the weight of the battery pack, which can be removed for lighter-weight transport. Like Superstrata, Arevo’s 3D-printed carbon fiber/polyamide bicycle launched in July 2020, the Scotsman is a direct-to-consumer product manufactured at Arevo’s Vietnam-based manufacturing facility. Also like Superstrata, each Scotsman is tailor-made for the customer’s height, weight, arm and leg lengths, and riding position — a level of customization said to be a world-first within the scooter industry. According to Sonny Vu, CEO of Arevo, the Scotsman’s design is intended to bridge the gap between bulky shared scooters and “toy-like” personal use scooters. Notes Josh Morenstein, founder of Branch Creative, the studio that worked with Arevo to design the Scotsman, “In designing the Scotsman, we wanted to elevate the scooter experience to a sophisticated alternative means of transportation that appeals to the urban professional commuting to work as much as the performance geek who wants the latest in electric mobility. Being able to 3D print in continuous carbon fiber composite enabled us to pursue designs not otherwise possible in other materials and fabrication techniques.” Vu adds, “Scotsman has many features for consumers in terms of connectivity and different customization options, but from a materials perspective, it’s really quite an innovation. Soctsman shows the capabilities of using continuous fiber 3D printing for very complex, curved parts and pieces you just couldn’t make from a traditional lamination approach. You certainly couldn’t customize each scooter.  You’d have to make multiple molded pieces that would have to be glued or welded together, adding weight and reducing the strength. We don’t do any of that. It’s just one piece coming out of the printer because our printer does prints up to a cubic meter.” The current production facility in Ho Chi Minh City, which will be fully operational this summer, houses 76 of Arevo’s robotic direct energy deposition (DED), continuous fiber composite 3D printers, which Vu says will be capable of printing 2,000 bike/scooter frames per month, or about 1 Superstrata frame per machine per day, and a little faster for a Scotsman frame. He notes that a new, even larger facility, in Da Nang, Vietnam, will open next year housing hundreds of 3D printers for increased production capacity. Additional high-end features of the Scotsman include: high-power motors (up to 2,000-watt output). dual motor system for added stability. dual regenerative brake system. proprietary composite suspension system. dual battery bay architecture for extended riding. quick release battery system that doubles as a USB-C powerbank to charge any devices. fully connected (always on GPS + cellular) riding experience, including Find My Scooter and Unlock features, and a built-in dashcam that has a Record My Ride feature. “With Superstrata and now Scotsman, our goal is to demonstrate what we can do,” Vu says. “We’re putting out very good products, made at scale, and brought to market really fast.” He notes that Arevo plans to leverage the skills and knowledge gained from both products to manufacture bicycle, electric vehicle and other components in future as well using the company’s 3D printing facilities. The Scotsman electric scooter will retail for $2,999 and is available for pre-order with special pricing now at Scotsman’s preorder website. Shipping begins in December 2021.