Metelimumab

Proceeds to accelerate clinical development of first-in-class bifunctional EGFR/TGF-β inhibitor, BCA101, for multiple cancer types, including 1L HPV-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) Presented positive interim clinical data at 2023 ASCO Annual Meeting and ESMO Congress 2023 from ongoing Phase 1/1b dose expansion study of BCA101 in combination with pembrolizumab demonstrating clinically meaningful anti-tumor activity and tolerable safety profile in 1L HPV-negative R/M HNSCC Financing co-led by Braidwell LP and TPG, with participation from other new and existing leading healthcare investors BOSTON, MA, USA I December 12, 2023 I Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics to elicit a potent and durable immune response, today announced the completion of an oversubscribed $165 million Series C financing. The financing was co-led by Braidwell LP and TPG, which is investing in the company through TPG Life Sciences Innovations (TPG LSI) and The Rise Fund, with additional new investors including Deerfield Management, Fairmount, Aisling Capital and a leading biotechnology investor associated with one of the largest alternative asset managers. All existing Series B investors also participated in the round. “Momentum at Bicara is increasing following our BCA101 Phase 1/1b data presentations at key 2023 medical meetings,” said Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics. “Our proof-of-concept data in frontline HPV-negative R/M HNSCC, a very difficult patient population to treat, underscore the promise of BCA101 as a new precision therapeutic option for these patients. With additional data readouts anticipated in 2024, we remain excited about the overall potential of BCA101 to help patients with HPV-negative R/M HNSCC, as well as other solid tumor types. We are thrilled to partner with this syndicate of new and existing leading healthcare investors, who share in our vision for BCA101 and Bicara’s bifunctional antibody platform.” In connection with the Series C financing, Carolyn Ng, Ph.D., Business Unit Partner with TPG LSI, has joined Bicara’s board of directors. “Bicara’s Phase 1/1b dose expansion study of BCA101 has delivered encouraging, clinically meaningful interim results and offers an excellent foundation from which to continue to build Bicara into a leading oncology company,” said Dr. Ng. “I am excited to join Bicara’s board of directors at such an important time and look forward to working with this talented management team and distinguished board of directors to advance new treatments for cancer patients.” With the completion of the Series C financing, Bicara has raised $273 million in 2023. About BCA101 BCA101 is a first-in-class, dual-action, bifunctional antibody designed to inhibit the epidermal growth factor receptor (EGFR) and disable transforming growth factor beta (TGF-β) directly at the tumor site. This approach is designed with the intent to allow BCA101 to inhibit tumor proliferation, while restoring the cytolytic activity of the local immune cells. BCA101 is currently being evaluated in a dose expansion phase of an open-label Phase 1/1b study in combination with pembrolizumab in patients with unresectable R/M HNSCC and advanced SqNSCLC and as a monotherapy for cutaneous squamous cell carcinoma. About Head and Neck Squamous Cell Carcinoma Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. Oral cavity and larynx cancers are generally associated with tobacco consumption, alcohol abuse or both, whereas pharynx cancers are increasingly attributed to infection with human papillomavirus (HPV), primarily HPV-16. Thus, HNSCC can be biologically separated into HPV-negative and HPV-positive HNSCC, the latter carrying a more favorable prognosis. Treatment approaches for locally advanced HNSCC generally consist of surgery followed by chemoradiotherapy (CRT) for oral cavity cancers and primary or definitive CRT for pharynx and larynx cancers. The immune checkpoint inhibitors pembrolizumab and nivolumab are approved by the U.S. FDA for treatment of platinum-refractory recurrent or metastatic HNSCC, and pembrolizumab is approved as first-line monotherapy in patients with unresectable or metastatic disease with a CPS ≥1 or combined with platinum and 5-fluorouracil for patients with any CPS score. HNSCC is the sixth most common cancer worldwide, with approximately 890,000 new cases and 450,000 deaths in 2018. The incidence of HNSCC continues to rise and is anticipated to increase by 30% by 2030. 1 About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to combine the precision of well validated, tumor-targeting antibodies with the power of tumor microenvironment modulators. The Company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, offering the potential for synergistic therapeutic impact at the site of the tumor. Bicara’s lead product candidate, BCA101, is a first-in-class EGFR/TGF-β-trap bifunctional antibody in clinical development for multiple tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X . SOURCE: Bicara Therapeutics

MIRAMAR, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2023. A human data readout from the ongoing Phase 1 clinical trial to evaluate HCW9218 in patients with chemo-refractory/chemo-resistant solid tumors was presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (“SITC”) by Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota, who serves as a Principal Investigator of this trial, which is sponsored by the University of Minnesota. Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “We believe the findings we shared in the preliminary human data readout at SITC provide support for future Phase 2 studies of HCW9218 in combination with chemotherapy and/or immune checkpoint inhibitors against solid tumors in patients with ovarian cancer. We are pleased to see the consistency of results in humans with those that we saw in our preclinical animal studies. Together, we believe these findings verify the balanced bifunctional activities of HCW9218 in stimulating effector immune cells and reducing TGF-β-mediated responses.” Business Highlights: The Company expects to complete the initial phase of both of its ongoing clinical studies in cancer indications in late 2023 or early 2024.Highlights of the human data readout from the Phase 1 clinical trial presented at SITC include: HCW9218 was administered subcutaneously once every three weeks for up to six cycles at dose levels 0.25 mg/kg (DL1), 0.5 mg/kg (DL2), 0.8 mg/kg (DL3) or 1.2 mg/kg (DL4). The median number of cycles was three.87% (13/15) had >4 lines of prior therapy. Tumor types included: Ovarian (n=6), Colorectal (n=4), Rectal (n=3), and Liver (n=2).53% (8/15) patients treated with HCW9218 were evaluated in a post-treatment assessment, including biopsies and scanning. Tumor types included: Ovarian (n=3), Colorectal (n=3), Rectal (n= 1) and Liver (n=1).50% (4/8) patients evaluated in post-treatment assessments exhibited stable disease following HCW9218 treatment. Patients showed stable disease lasting over 6 months. Clinical benefit was observed from DL2, DL3 and DL4.66% (2/3) patients with ovarian cancer who underwent post-treatment assessments showed stable disease.HCW9218 significantly reduced blood levels of TGF-β in cancer patients in a dose-dependent manner, without causing treatment-emergent skin lesions and bleeding events previously reported with TGF-β antagonists in clinic.Based on the ability of HCW9218 to activate, expand and induce tumor trafficking of progenitor exhausted stem-like and transitory CD8+ T cells, HCW9218 treatment presents a promising approach to enhancing the antitumor activity of immune checkpoint inhibitors in patients with solid tumors.Repeated HCW9218 administration up to the highest planned dose level was well tolerated by patients with chemotherapy-refractory advanced solid tumors, which has provided support for the Recommended Phase 2 Dose level for future Phase 2 studies of HCW9218. Third Quarter 2023 Financial Results: Revenues: Revenues for the quarter ended September 30, 2022 and 2023 were $1.8 million and $853,102, respectively. Revenues for the nine months ended September 30, 2022 and 2023 were $5.4 million and $1.5 million, respectively. Revenues were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the inputs for manufacturing Wugen’s products. The Company expects Wugen to limit its purchases for the remainder of 2023, due primarily to changes in its clinical development program and delays in ramping up its manufacturing process.Research and development (R&D) expenses: R&D expenses for the quarter ended September 30, 2022 and 2023 were $2.6 million and $1.7 million, respectively, a decrease of $981,352, or 37%. R&D expenses for the nine months ended September 30, 2022 and 2023 were $6.4 million and $5.5 million, respectively, a decrease of $868,434, or 14%. The change is primarily attributable to a decrease in preclinical expenses and manufacturing costs and an increase in costs associated with clinical trial activities. As of September 30, 2023, the Company anticipates it has the required supplies of its lead molecules, HCW9218 and HCW9302, in place to provide for planned clinical development activities for the next 20-24 months. In the three months ended September 30, 2023, costs were incurred primarily for master cell bank characterization for HCW9101H, a high-producing cell line of a key component of the manufacturing process for the Company's proprietary molecules including those licensed to Wugen, as well as ancillary activities such as shipping, insurance and storage. During this period, all preclinical costs were incurred to complete IND-enabling activities for HCW9302. The Company expects to submit an IND application for permission to conduct a clinical trial to evaluate HCW9302 in an autoimmune disorder by the end of 2023.General and administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2022 and 2023 were $1.7 million and $3.6 million, respectively, an increase of $1.9 million, or 107%. G&A expenses for the nine months ended September 30, 2022 and 2023 were $5.3 million and $9.7 million, respectively, an increase of $4.4 million, or 83%. The increase was primarily attributable to increases in professional fees, which include legal fees associated with legal proceedings brought against the Company by Altor BioScience, LLC and NantCell, Inc., or Altor/NantCell, which is discussed further below.Net loss: Net loss for the quarter ended September 30, 2022 and 2023 was $3.9 million and $4.9 million, respectively, an increase of $1.0 million, or 26%. Net loss for the nine months ended September 30, 2022 and 2023 was $9.5 million and $14.3 million, respectively, an increase of $4.8 million, or 51%. Financial Guidance As of September 30, 2023, the Company held $11.2 million in cash and cash equivalents. In addition, the Company recognized prepaid expenses of $1.7 million, and a deposit for interest reserve of $5.3 million. The Company advanced $4.4 million toward its new lab and manufacturing facilities prior to drawing funds available under the 2023 Loan Agreement. With the current cash and cash equivalents and funds available to the Company under the 2023 Loan Agreement, including recouping the amounts advanced toward its new lab and manufacturing facilities, the Company believes it has adequate capital to fund operations and other commitments to the end of 2024. On April 27, 2023, in connection with the Altor/NantCell matter, the U.S. District Court for the Southern District of Florida (the “Court”) approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Altor/NantCell’s proceeding against the Company is now proceeding in arbitration before JAMS. Although adverse decisions (or settlements) may occur in arbitration, it is not possible to reasonably estimate the possible loss or range of loss, if any, associated therewith at this time. As such, no accrual for these matters has been recorded within the Company’s financial statements. In the year ahead, the Company expects to continue to incur legal expenses on its own behalf in connection with the legal proceedings brought against it by Altor/NantCell. Further, while legal expenses incurred by Dr. Wong in connection with the arbitration against him that was initiated by Altor/NantCell are covered through advancement of expenses from Altor/NantCell, under certain circumstances, the Company may be required to advance his legal fees. The Company incurred legal expenses on its own behalf in the period ended September 30, 2023, and it expects to continue to incur material costs and expenses in connection with defending itself in the foregoing legal matters through the end of 2023 and into 2024. About HCW Biologics HCW Biologics is a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation, and age-related diseases, such as cancer, cardiovascular diseases, diabetes, neurodegenerative diseases, autoimmune diseases, as well as other conditions such as long-haul COVID-19. The Company has combined a deep understanding of disease-related immunology with its expertise in advanced protein engineering to develop the TOBI™ (Tissue factOr-Based fusIon) discovery platform. The Company uses its TOBITM discovery platform to generate designer, novel multi-functional fusion molecules with immunotherapeutic properties. The invention of HCW Biologics’ two lead molecules, HCW9218 and HCW9302, was made via the TOBI™ discovery platform. The Company currently has two ongoing clinical trials to evaluate HCW9218 in cancer indications. The Masonic Cancer Center, University of Minnesota, is the sponsor of a Phase 1 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant solid tumors that have progressed after prior chemotherapies (Clinicaltrials.gov: NCT05322408). The Company is the sponsored of a Phase 1b/2 clinical trial to evaluate HCW9218 in chemo-refractory/chemo-resistant advanced pancreatic cancer (Clinicaltrials.gov: NCT05304936). The Company’s lead molecule for its regulatory T cell expansion program, HCW9302, is currently undergoing IND-enabling studies for an autoimmune indication. Forward Looking Statements Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, without limitation, statements regarding completion of Phase 1/1b clinical studies in cancer; potential of HCW9218 to treat other aging-associated diseases beyond cancer; potential of HCW9218 as a combination therapy with checkpoint inhibitors and of HCW9218’s mechanism of action; timing of completion for trials; the Company’s cash runway; the Company’s expectations regarding future purchases by Wugen; timing of submission of INDs; duration of the supply of the Company’s lead molecules; and timing and outcome of the Altor/NantCell arbitration and the Company’s liability related thereto. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 28, 2023, the Form 10-Q filed with the SEC on November 14, 2023, and in other filings filed from time to time with the SEC. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Company Contact:Rebecca ByamCFOHCW Biologics Inc.rebeccabyam@hcwbiologics.com HCW Biologics Inc.Condensed Statements of Operations(Unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2022 2023 2022 2023 Revenues: Revenues $1,809,025 $853,102 $5,380,570 $1,517,792 Cost of revenues (1,447,220) (678,325) (3,062,496) (1,210,077) Net revenues 361,805 174,777 2,318,074 307,715 Operating expenses: Research and development 2,648,794 1,667,442 6,408,353 5,539,919 General and administrative 1,732,666 3,585,215 5,321,262 9,716,765 Total operating expenses 4,381,460 5,252,657 11,729,615 15,256,684 Loss from operations (4,019,655) (5,077,880) (9,411,541) (14,948,969) Interest expense (32,184) (95,514) (32,184) (284,465) Other (expense) income, net 137,645 234,753 (38,237) 919,688 Net loss $(3,914,194) $(4,938,641) $(9,481,962) $(14,313,746) Net loss per share, basic and diluted $(0.11) $(0.14) $(0.26) $(0.40) Weighted average shares outstanding, basic and diluted 35,835,135 35,926,921 35,809,216 35,907,123 HCW Biologics Inc.Condensed Balance Sheets December 31, September 30, 2022 2023 Unaudited ASSETS Current assets: Cash and cash equivalents $22,326,356 $11,220,793 Short-term investments 9,735,930 — Accounts receivable, net 417,695 710,078 Prepaid expenses 1,394,923 1,742,341 Other current assets 196,015 174,881 Total current assets 34,070,919 13,848,093 Investments 1,599,751 1,599,751 Property, plant and equipment, net 10,804,610 14,780,872 Deposit for interest reserve — 5,250,000 Other assets 333,875 137,626 Total assets $46,809,155 $35,616,342 LIABILITIES AND STOCKHOLDERS’ EQUITY Liabilities Current liabilities: Accounts payable $1,226,156 $3,153,834 Accrued liabilities and other current liabilities 1,730,325 2,262,839 Total current liabilities 2,956,481 5,416,673 Debt, net 6,409,893 6,332,736 Other liabilities 14,275 — Total liabilities 9,380,649 11,749,409 Commitments and contingencies (Note 8) Stockholders’ equity: Common stock: Common, $0.0001 par value; 250,000,000 shares authorized and 35,876,440 shares issued at December 31, 2022; 250,000,000 shares authorized and 35,927,321 shares issued at September 30, 2023 3,588 3,593 Additional paid-in capital 82,962,964 83,715,133 Accumulated deficit (45,538,046) (59,851,793)Total stockholders’ equity 37,428,506 23,866,933 Total liabilities and stockholders’ equity $46,809,155 $35,616,342