NB-0893

WUXI, China, Nov. 14, 2023 /PRNewswire/ -- 2023 BIO-Europe just closed last week. In line with previous conferences, this BD carnival attracted more than 2,000 companies, 5,000 attendees from close to 60 countries all over the world. Recently, we interviewed a global BD expert, Dr. Kaan Certel. He was formerly the Global Head of Oncology External Innovation, Sanofi Partnering. Now he serves as Chief Business Officer of Biocity Pharmaceutics, a Chinese biotech. Form both angles, he shared his views on Chinese biotech transformation and the key points and prospects of BD collaboration between Chinese biotech and MNCs. Q: Congratulations on your new position! Firstly, why did you choose to join BioCity? What are the highlights of this company? A: BioCity is a young, significantly differentiated innovative Chinese biotech with a competitive portfolio in oncology and chronic kidney disease including 7 exciting assets in clinical development phase. The company was founded by Mr. Xiang Bo Jia and Dr. Ivy Wang in 2017. Subsequently, the cofounders recruited Dr. Yong Jiang Hei as the Co-CEO and CMO. The leadership built the company on solid foundation: A patient-centric approach that aims to develop innovative drugs with urgency, born out of a deep understanding of the disease biology and target space. Importantly, each decision point of the development process is data driven. While patient care is front and center, this strategy also creates programs with robust commercial value across all geographies. The approach and the philosophy of the company is an excellent example of the transformation that is exciting the multinationals, who are seeking novel pathways and biology to target, particularly in oncology. In my assessment of thousands of companies during my previous role in Sanofi as the Global Head of Oncology External Innovation, I have rarely come across biotech that brought together all these qualities in China or elsewhere. Therefore, it was not a difficult decision to join this progressive company. Q: Thank you. According to your experience and observation, how's the biotech scene changing in China? A: Over the last few years, China has taken the global lead in scientific innovation. A report published by Japan's National Institute of Science and Technology Policy (NISTP) and printed by the Guardian found that China now publishes the highest number of papers annually, followed by the US and Germany. According to the article, China not only overtook the US in terms of the number of papers published but also in terms of the high impact studies. We're now beginning to see the translation of this progress into innovative pipelines, transforming the face of biotech in China. While emulating the success of proven assets with a fast-follower, me-too approach still prevalent, a few companies are taking the lead by building exciting pipelines with First-in-Class assets targeting novel pathways and biology. The clear recognition of the success of this approach is evident by the recent partnerships between multiple multinational pharma and relatively small Chinese biotech companies. The relatively rich deal terms reflect the potential impact of these programs on improving patients' lives. Oncology still dominates the innovation space, but a few companies are expanding this horizon into additional therapeutic space, such as immune/inflammation, metabolic disorder, and kidney disease. Q: Let's get back to BD. What strategies should a biotech company follow to create a competitive pipeline? A: The company pipeline must strategically combine three concepts: addressing unmet need, performing high quality science, and creating commercial opportunity. This philosophy is essential to create value for patients and shareholders. The pathways and biology explored must be well-validated in the context of the disease. Companies should be open-minded about the modality, the mode-of-action of addressing a target should be scientifically driven. Innovation does not reward copycats, nor should it be taken at face value. Nowadays it becomes more and more difficult to draw a fine line between small molecule companies andbiologics companies. Of course, platform companies will continue to emerge, but they will continue to face significant challenges on the investment side since it's very difficult to assign value to a platform. One productive model is to build a pipeline consisting of pillars that can create synergies through potential combination therapy strategies to address multiple indication spaces, maximizing the opportunity space and asset reach by those in need. The growth of the company will be catalyzed by building around these pillars to solidify the position of the company. BioCity has accomplished this by building a portfolio that focuses on three pillars in oncology: DNA Damage Response (DDR) pathway, Immunooncology, and Antibody-drug conjugates (ADCs). As a result, BioCity is well-positioned to address both the FIC and the BIC spaces with multiple modalities including small molecules, multi-specific antibodies, and antibody-drug conjugates (ADCs) across multiple therapeutic areas. Q: How should biotech companies think about the risks associated with innovation? A: An important component for the continued success of Chinese biotech transformation is the strategic focus. Creating a portfolio of innovative products require novel approaches and calculated risk taking. A great example of this is the current dominant position of Chinese biotech companies in ADC space. Novel targets, novel conjugation methods, and novel cytotoxic payloads differentiate the assets and grab the attention of large pharma companies that are on the hunt for novel assets. The approach should be a strategic one. The value of yet another KRasG12C, or PD-1 inhibitor is not compelling for the investors or the patients. The strategy should begin with understanding the current need and the landscape for each indication and finding the right path to innovation. It is critical to understand the Return on Investment (ROI) for each portfolio asset. The leadership must carefully analyze the investment necessary to develop each program to a point of partnership and put that in the context of expected return from that asset, including the patient population that could potentially benefit from it. Of course, the goal is not to create a pipeline solely focused on a large ROI. The company strategy should favor a balanced portfolio driven by both science and business. Q: What are MNCs prioritizing for potential collaborations, and what are the key points to be taken for Chinese biotech? A: Large pharma companies look for First-in-Class (FIC)/Best-in-Class (BIC) assets with significant commercial potential across the globe. Currently, multiple large pharma companies face significant portfolio challenges in the form of patent cliffs and clinical trial failures. The industry overall is under significant stress and the investor confidence is low. Multinationals are continually reassessing their strategic priorities while focusing their pipelines. Loss of exclusivity and late-stage clinical trial failures pressure the large pharma companies to leverage partnerships, especially on clinical-stage programs, to bridge the revenue gap they are facing. In this current climate, there's significant incentive to focus on and expedite the development of promising programs with compelling data. In order to reduce risk, large pharma companies are prioritizing programs with efficacy signal and good safety profile. Although multinational companies rely heavily on scientific and commercial diligence in their collaboration decisions, they understand that when they enter into a partnership, they are also investing into team expertise in addition to the asset. Therefore, the quality of the teams is just as important as the assets. In this regard, once again, BioCity presents a great example. At BioCity, high-quality pipeline assets are developed by an experienced and dedicated team both in China and the US. Q: What are some important considerations in structuring a deal that you could share? A: First and foremost, it is crucial to select the right partner to enter into complex, at times difficult negotiation process. The partner should be willing to listen to BioCity concerns and address them in mutually beneficial ways. The process moves much more efficiently with a partner that share the same fundamental philosophies. The economic terms of the deal are, of course, important, particularly for the small biotech whose investment represents a significant risk. The upfront and milestone amounts should reward the success of the programs in recognition of that fact. Partners will also have to align on sharing the rights to the programs across various geographies. Promotion and commercialization terms in this regard are very important as strength in this area will determine the reach of the drug and drive sales. For example, BioCity will prioritize retaining the rights in China for development and commercialization while utilizing partner capabilities in the rest of the world as it would not be practical to invest into a global commercialization force for BioCity at this phase of the company. Similarly, rights governing further clinical and preclinical research on the targets must be balanced to allow both parties to expand the benefits of the program. In doing so, however, small biotech companies need to be cognizant of the resource limitations as overstretching the goals could create significant financial stress on the company. Finally, in my view, one of the most critical parts of the contract is the termination clause. While we always plan for success, we should also be prepared for the failure of the programs at various stages and plot exactly how we will manage potential outcomes before we face them. Q: Thank you. Our second-to-last question: what is BioCity's partnering strategy? A: A successful partnering strategy should focus on maximizing the value of the programs and providing global access to patients across geographies expeditiously. Most large oncology indications remain as high unmet need spaces with dismal 5-year survival expectancy. Therefore, BioCity BD team will focus on partners that will help speed up progress in clinic across broad indication spaces. Our aim is to create deal structures that will set up a win-win-win scenario for both partners as well as the patients. As we develop into a global company born in China, we also recognize the importance of retaining significant value of our programs in China through creative deal structuring. This will pave the path for strengthening our clinical development capabilities and building a commercial force in China. For ex-China territories, we will focus on leveraging partner's global capabilities in clinical development and commercialization. The goal of our BD activities at BioCity is to create value for our shareholders and the patients. Q: Last question. How will the BioCity BD team work together to execute on this strategy? We have now begun to reach out to MNCs to socialize our clinical stage programs to explore potential partnership paths. As we meet with our potential partners, we are learning about what additional data that might be necessary to move into deeper licensing discussions. Based on this information we are in the process of assessing each program under multiple partnership scenarios to position the entire portfolio in the strongest possible shape. We have initiated good dialogue with multiple potential partners, and we will continue to cultivate these relationships as we advance the programs to their appropriate inflection points. We believe the inflections would happen not far in the future. Based on the portfolio with great potential, BioCity has built a young, energetic, and competent BD team. As the leader of this team, I am excited to work side by side with my team members and help guide their professional development process. I have all the confidence that the team will blossom into a strong group of BD professionals in a relatively short period of time. The team's development will play an important role in the short-term partnering activities as well as the long-term growth phase of the company. About Dr. Kaan Certel Dr. Kaan Certel has over 20 years of academic and industry experience. He is a globally recognized business development expert, also he is a cancer biologist with a deep understanding of genetics, cell biology, and immunology. Recently, Kaan has been appointed as the Chief Business Officer of Biocity Biopharmaceutics. In this role, he is responsible of leading the company's global BD activities, and supporting strategic management affairs. Before joining BioCity, he was the Global Head of Oncology External Innovation, Sanofi Partnering, where he led a team of senior level professionals to identify and assess potential in-licensing and collaboration opportunities. His previous R&D experience includes small molecule discovery at X-Chem Pharmaceuticals and antibody discovery at X-Body Biosciences, which is now a part of Bristol Myer Squibb. His expertise expands multiple therapeutic areas such as oncology, immune-oncology, and autoimmune diseases. Kaan received his Ph.D. degree in Genetics from the University of Iowa and had his postdoctoral training in the Koch Institute for Integrative Cancer Research at MIT. About BioCity Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including chronic kidney diseases (CKD). The company has established a pipeline of more than 10 innovative drug candidates based on diversified modalities including small molecules, monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). Currently, BioCity Biopharma has 6 oncology assets in Phase 1 development, including the first-in-Class CDH3-targeting ADC, agents targeting the DNA damage response (DDR) pathway via a WEE1 and an ATR inhibitor, and agents targeting the immune system including a T cell engager (CD3/EGFR BsAb), an immune checkpoint inhibitor (TIM-3 mAb), and a T cell activator (4-1BB mAb). In addition, an endothelin A (ETA)-receptor selective antagonist for CKD is in phase 2 randomized trial. For more information, please visit: Contact: [email protected] IR@biocitypharma.com SOURCE BioCity Biopharma

Initiated a global Phase 2b trial to treat rheumatoid arthritis (RA) with rosnilimab, our PD-1 agonist Initiating in Q4 2023 a global Phase 2 trial to treat ulcerative colitis (UC) with rosnilimab Announced positive top-line Phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP) Reiterating cash runway through year-end 2026 and updating expected year-end 2023 cash and investments of $400 to $410 million SAN DIEGO, Nov. 02, 2023 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported operating results for the third quarter ended September 30, 2023 and provided a business update. “We’ve made strong progress this quarter executing against our multi-year plan to develop best-in-class immune cell modulators to drive differentiated clinical outcomes in heterogeneous, systemic autoimmune and inflammatory diseases,” said Daniel Faga, president and chief executive officer of Anaptys. “Enrollment is ongoing in our global Phase 2b trials in atopic dermatitis for ANB032, our BTLA agonist, and rheumatoid arthritis for rosnilimab, our PD-1 agonist, while also initiating a global Phase 2 trial in ulcerative colitis for rosnilimab in Q4 2023.” Updates on Wholly Owned Immune Cell Modulator Pipeline Rosnilimab (PD-1 agonist antibody) Initiated in August a global Phase 2b trial in moderate-to-severe RA 420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70 At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period Top-line Week 12 data anticipated by mid 2025 Anticipate initiation in Q4 2023 of a global Phase 2 trial in moderate-to-severe UC 130-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period Top-line Week 12 data anticipated by H1 2026 Hosted a virtual PD-1 Agonist (Rosnilimab) R&D Event in October 2023 Replay of the audio webcast is available here Announcing two poster presentations at American College of Rheumatology (ACR) Convergence 2023 in San Diego, Nov. 10-15, 2023. Full preliminary program is available online on the ACR website - Optimizing PD-1 Agonist Signaling with Membrane Proximal Binding of Rosnilimab, a Clinical Stage PD-1 Agonist IgG1 Antibody (abstract #0086) Rosnilimab, a Novel PD-1 Agonist Monoclonal Antibody, Inhibits Peripheral T Cell Proliferation and Cytokine Secretion and Reduces Circulating PD-1 High Expressing T Cells: Results from a Phase 1 Healthy Volunteer Clinical Trial (abstract #0455) ANB032 (BTLA agonist antibody) Enrollment ongoing for global Phase 2b trial in moderate-to-severe atopic dermatitis (AD) 160-patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI75 and IGA 0/1 Top-line Week 14 data anticipated by year-end 2024 Presented poster on ANB032’s previously reported healthy volunteer Phase 1 data and a trial-in-progress poster presentation on ANB032’s Phase 2b study in moderate-to-severe AD at the 32 European Academy of Dermatology and Venerology (EADV) Congress in October 2023 Poster presentations are available here ANB033 (anti-CD122 antagonist antibody) Plan to submit an Investigational New Drug (IND) application in H1 2024 Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing Announced positive top-line Phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP) 53.3% of patients who received a single dose of 750mg IV imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4 (primary endpoint), compared to 13.3% of patients on placebo (p=0.0131) Demonstrated favorable safety and tolerability with no SAEs, low incidence and no increase of infections vs. placebo and no cases of DRESS or Guillain-Barre in imsidolimab-treated patients Only one of 30 (3.3%) imsidolimab-treated patients had detectable ADA, which were non-neutralizing Intend to out-license imsidolimab in 2024 Updates on GSK Immuno-Oncology Financial Collaboration GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer Anaptys has regained full global rights to GSK4074386, a Phase 2 ready LAG-3 antagonist antibody, from GSK Year-End Cash Guidance Reiterating cash runway through year-end 2026 with updated expected year-end 2023 cash and investments of $400 to $410 million Third Quarter Financial Results Cash, cash equivalents and investments totaled $453.3 million as of September 30, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $130.9 million. The decrease relates to cash used for the $50 million stock repurchase program and operating activities. Collaboration revenue was $3.3 million and $8.2 million for the three and nine months ended September 30, 2023, compared to $1.3 million and $3.5 million for the three and nine months ended September 30, 2022. The change is due primarily to increased royalties recognized for sales of Jemperli. Research and development expenses were $30.9 million and $98.8 million for the three and nine months ended September 30, 2023, compared to $22.1 million and $65.4 million for the three and nine months ended September 30, 2022. The increase was due primarily to manufacturing and development costs for rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.2 million and $7.7 million for the three and nine months ended September 30, 2023 as compared to $1.5 million and $5.0 million in the same period in 2022. General and administrative expenses were $10.2 million and $31.7 million for the three and nine months ended September 30, 2023, compared to $8.9 million and $27.2 million for the three and nine months ended September 30, 2022. The G&A non-cash, stock-based compensation expense was $5.6 million and $17.4 million for the three and nine months ended September 30, 2023 as compared to $4.7 million and $15.7 million in the same period in 2022. Net loss was $37.3 million and $121.4 million for the three and nine months ended September 30, 2023, or a net loss per share of $1.41 and $4.49, compared to a net loss of $33.5 million and $102.3 million for the three and nine months ended September 30, 2022, or a net loss per share of $1.18 and $3.64. About Anaptys Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and a planned Phase 2 trial for the treatment of ulcerative colitis; and ANB032, its BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis. Its preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody, for the treatment of autoimmune and inflammatory diseases. In addition, Anaptys has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)) and an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) in second line NSCLC. To learn more, visit or follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of initiation of the Company’s clinical trials, including rosnilimab’s clinical trial in ulcerative colitis; the timing of the release of data from the Company’s clinical trials, including rosnilimab’s Phase 2b clinical trial in rheumatoid arthritis and Phase 2 clinical trial in ulcerative colitis and ANB032’s Phase 2b clinical trial in atopic dermatitis; the timing of ANB033’s IND filing; whether any of the Company’s product candidates will be best in class; the potential to receive any additional royalties from the GSK collaboration; the Company’s ability to find a licensing partner for imsidolimab or etokimab and the timing of any such transaction; and the Company’s projected cash runway and estimated year-end cash balance. Statements including words such as “plan,” “intend,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Contact: Nick Montemarano Senior Director, Investor Relations and Strategic Communications 858.732.0178 investors@anaptysbio.com AnaptysBio, Inc. Consolidated Balance Sheets (in thousands, except par value data) (unaudited) September 30, 2023 December 31, 2022 ASSETS Current assets: Cash and cash equivalents $ 26,295 $ 71,308 Receivables from collaborative partners 3,269 1,419 Short-term investments 386,752 369,933 Prepaid expenses and other current assets 11,684 4,545 Total current assets 428,000 447,205 Property and equipment, net 2,254 2,089 Operating lease right-of-use assets 16,613 17,898 Long-term investments 40,203 142,935 Other long-term assets 256 256 Total assets $ 487,326 $ 610,383 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 6,521 $ 2,784 Accrued expenses 30,916 21,633 Current portion of operating lease liability 1,741 1,637 Total current liabilities 39,178 26,054 Liability related to sale of future royalties 311,272 304,413 Operating lease liability, net of current portion 16,493 17,813 Stockholders’ equity: Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at September 30, 2023 and December 31, 2022, respectively — — Common stock, $0.001 par value, 500,000 shares authorized, 26,575 shares and 28,513 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively 27 29 Additional paid in capital 694,591 717,797 Accumulated other comprehensive loss (2,350 ) (5,246 ) Accumulated deficit (571,885 ) (450,477 ) Total stockholders’ equity 120,383 262,103 Total liabilities and stockholders’ equity $ 487,326 $ 610,383 AnaptysBio, Inc. Consolidated Statements of Operations and Comprehensive Loss (in thousands, except per share data) (unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Collaboration revenue $ 3,318 $ 1,293 $ 8,152 $ 3,479 Operating expenses: Research and development 30,878 22,064 98,758 65,424 General and administrative 10,172 8,862 31,670 27,236 Total operating expenses 41,050 30,926 130,428 92,660 Loss from operations (37,732 ) (29,633 ) (122,276 ) (89,181 ) Other income (expense), net: Interest income 4,854 2,262 13,993 3,711 Non-cash interest expense for the sale of future royalties (4,431 ) (6,135 ) (13,125 ) (16,857 ) Other income, net 1 4 — 16 Total other income (expense), net 424 (3,869 ) 868 (13,130 ) Net loss (37,308 ) (33,502 ) (121,408 ) (102,311 ) Unrealized gain (loss) on available for sale securities 1,261 (2,146 ) 2,896 (5,585 ) Comprehensive loss $ (36,047 ) $ (35,648 ) $ (118,512 ) $ (107,896 ) Net loss per common share: Basic and diluted $ (1.41 ) $ (1.18 ) $ (4.49 ) $ (3.64 ) Weighted-average number of shares outstanding: Basic and diluted 26,546 28,289 27,038 28,071